COOK Medical Zenith Flex Series Instructions For Use Manual

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MEDICAL

Zenith Flex® AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System

Instructions for Use

Endovaskulární graft Zenith Flex® AAA se zaváděcím systémem H&L-B One-Shot™

Návod k použití

Zenith Flex® AAA endovaskulær protese med H&L-B One-Shot™ indføringssystem

Brugsanvisning

Endovaskuläre AAA-Prothese Zenith Flex® mit H&L-B One-Shot™ Einführsystem

Gebrauchsanweisung

Ενδαγγειακό μόσχευμα AAA Zenith Flex® με το σύστημα εισαγωγής H&L-B One-Shot™

Οδηγίες χρήσης

Endoprótesis vascular para AAA Zenith Flex® con el sistema de introducción H&L-B One-Shot™

Instrucciones de uso

Endoprothèse vasculaire Zenith Flex® AAA à système d’introduction H&L-B One-Shot™

Mode d’emploi

Zenith Flex® AAA endovaszkuláris graft H&L-B One-Shot™ felvezetőrendszerrel

Használati utasítás

Endoprotesi addominale Zenith Flex® con sistema di introduzione H&L-B One-Shot™

Istruzioni per l’uso

Zenith Flex® AAA endovasculaire prothese met H&L-B One-Shot™ introductiesysteem

Gebruiksaanwijzing

Zenith Flex® AAA endovaskulært implantat med H&L-B One-Shot™ innføringssystem

Bruksanvisning

Stent-graft wewnątrznaczyniowy Zenith Flex® AAA z systemem wprowadzającym H&L-B One-Shot™

Instrukcja użycia

Prótese endovascular AAA Zenith Flex® com o sistema de introdução H&L-B One-Shot™

Instruções de utilização

Zenith Flex® AAA endovaskulära transplantat med H&L-B One-Shot™ införingssystem

Bruksanvisning

*T_ZAAAF36_REV7*

ENGLISH

TABLE OF CONTENTS

1 DEVICE DESCRIPTION ................................................23

1.1 Aortic Main Body and Iliac Leg Components ........................23

1.2 Main Body Delivery System .........................................23

1.3 Iliac Leg Delivery System ...........................................23

1.4 Zenith AAA Endovascular Graft Ancillary Components ..............23

2 INDICATIONS FOR USE ...............................................23

3 CONTRAINDICATIONS ................................................23

4 WARNINGS AND PRECAUTIONS ......................................23

4.1 General ...........................................................23

4.2 Patient Selection, Treatment and Follow-Up .......................23

4.3 Pre-Procedure Measurement Techniques and Imaging ............23

4.4 Device Selection .................................................24

4.5 Implant Procedure ............................................... 24

4.6 Molding Balloon Use ............................................. 24

4.7 MRI Safety and Compatibility ......................................24

5 ADVERSE EVENTS ....................................................24

5.1 Observed Adverse Events ..........................................24

Table 5.1.1 Death and Rupture from Clinical Study .................24

Table 5.1.2 Adverse Events in Clinical Study ........................25

5.2 Potential Adverse Events ...........................................25

Device Related Adverse Event Reporting ..........................25

6 SUMMARY OF CLINICAL STUDIES .....................................25

6.1 Objectives .........................................................25

6.2 Study Design .......................................................25

Table 6.2.1 Patient Follow-Up and Accountability ..................26

6.3 Patient Demographics ..............................................26

Table 6.3.1 Comparison of Subject Characteristics ..................26

Table 6.3.2 Aneurysm Diameter Distribution .......................26

6.4 Results .............................................................26

Table 6.4.1 Devices Implanted .....................................26

Table 6.4.2 Primary Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

Table 6.4.3 Success Measures .....................................28

Table 6.4.4 Abdominal Radiographic Findings – Device Integrity ...28

Table 6.4.5 CT Findings – Graft Patency ............................28

Table 6.4.6 CT Findings – Graft (Main Body) Migration ..............28

Table 6.4.7 Abdominal Radiograph Findings – Limb Separation ....29

6.5 Endoleak Management .............................................29

Table 6.5.1 Endoleaks (All Types, New and Persistent) ..............29

Table 6.5.2 First Occurrence of Endoleak for Standard Risk Patients .29

Table 6.5.3 First Occurrence of Endoleak for High Risk Patients .....29

Table 6.5.4 First Occurrence of Endoleak for Roll-in Patients ........29

6.6 Aneurysm Change .................................................30

Table 6.6.1 Change in Maximum Aneurysm Diameter by Interval ...30 Table 6.6.2 Change in Aneurysm Size and Endoleak at 12 Months ..30 Table 6.6.3 Change in Aneurysm Size and Endoleak at 24 Months ..30

6.7 AAA-Related Secondary Interventions ..............................30

Table 6.7.1 Secondary Interventions (to 12 Months) ................30

Table 6.7.2 Secondary Interventions (>12 to 24 Months) ...........30

6.8 Secondary Outcome Measures .....................................31

Table 6.8.1 Secondary Outcomes by Treatment Group .............31

7 PATIENT SELECTION AND TREATMENT ................................31

Individualization of Treatment .........................................31

8 PATIENT COUNSELING INFORMATION .................................31

9 HOW SUPPLIED ......................................................31

10 CLINICAL USE INFORMATION ........................................31

10.1 Physician Training .................................................31

10.2 Inspection Prior to Use ............................................31

10.3 Materials Required ...............................................31

10.4 Materials Recommended .........................................31

10.5 Device Diameter Sizing Guidelines ................................32

Table 10.5.1 Main Body Graft Diameter Sizing Guide ...............32

Table 10.5.2 Iliac Leg Graft Diameter Sizing Guide

11 DIRECTIONS FOR USE ...............................................32

Anatomical Requirements .............................................32

General Use Information ...............................................32

Pre-Implant Determinants .............................................32

Patient Preparation ....................................................32

11.1 Bifurcated System ................................................32

11.1.1 Bifurcated Main Body Preparation/Flush ....................32

11.1.2 Contralateral Iliac Leg Preparation/Flush ....................32

11.1.3 Ipsilateral Iliac Leg Preparation/Flush .......................32

11.1.4 Vascular Access and Angiography ..........................32

11.1.5 Main Body Placement ......................................32

11.1.6 Contralateral Iliac Wire Guide Placement ....................32

11.1.7 Main Body Proximal (Top) Deployment .....................33

11.1.8 Contralateral Iliac Leg Placement and Deployment ..........33

11.1.9 Main Body Distal (Bottom) Deployment .....................33

11.1.10 Docking of Top Cap .......................................33

11.1.11 Ipsilateral Iliac Leg Placement and Deployment ...........33

11.1.12 Molding Balloon Insertion ................................33

12 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP ............33

12.1 General ..........................................................33

12.2 Contrast and Non-Contrast CT Recommendations .................34

12.3 Abdominal Radiographs ..........................................34

12.4 Ultrasound. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

12.5 MRI Safety and Compatibility ......................................34

12.6 Additional Surveillance and Treatment ............................34

13 PATIENT TRACKING INFORMATION ................................ 34

14 TROUBLESHOOTING ..............................................34

14.1 Trigger-Wire Release Troubleshooting ........................... 34

14.2 Suprarenal Stent Deployment Troubleshooting ....................35

Final Angiogram ..........................................33

Table 12.1 Recommended Imaging Schedule

for Endograft Patients .............................................34

Table 12.2 Acceptable Imaging Protocols ..........................34

14.1.1 Main Body Proximal (Top) Deployment

14.1.2 Docking of Top Cap

14.1.3 Ipsilateral Iliac Leg Placement and Deployment

14.1.4 Contralateral Iliac Leg Placement and Deployment

14.2.1 Main Body Proximal (Top) Deployment .....................35

14.2.2 Docking of Top Cap ........................................35

14.2.3 Ipsilateral Iliac Leg Placement and Deployment .............35

14.2.4 Contralateral Iliac Leg Placement and Deployment ..........35

........................................35

..................32

.....................34

............35

.........35

ČESKY

OBSAH

1 POPIS ZAŘÍZENÍ ...................................................36

1.1 Komponenty aortálního hlavního těla a iliakálního ramena ........36

1.2 Aplikační systém hlavního těla ....................................36

1.3 Aplikační systém pro iliakální rameno .............................36

1.4 Pomocné komponenty endovaskulárního graftu Zenith AAA ......36

2 URČENÉ POUŽITÍ ..................................................36

3 KONTRAINDIKACE .................................................36

4 VAROVÁNÍ A UPOZORNĚNÍ .........................................36

4.1 Obecně ...........................................................36

4.2 Výběr, léčba a následné kontroly pacienta .........................36

4.3 Měřicí techniky a zobrazování před výkonem .....................36

4.4 Volba zařízení ....................................................37

4.5 Postup implantace ...............................................37

4.6 Použití tvarovacího balónku ......................................37

4.7 Bezpečnost a kompatibilita vyšetření MRI ...........................37

5 NEŽÁDOUCÍ PŘÍHODY ............................................. 37

5.1 Zaznamenané nežádoucí příhody ................................37

Tabulka 5.1.1 Úmrtí a ruptura v klinické studii ....................37

Tabulka 5.1.2 Nežádoucí příhody v klinické studii ................ 38

5.2 Potenciální nežádoucí příhody ....................................38

Hlášení nežádoucích příhod souvisejících se zařízením ............. 38

6 SOUHRN KLINICKÝCH STUDIÍ .......................................38

6.1 Cíle ..............................................................38

6.2 Uspořádání studie ................................................38

Tabulka 6.2.1 Kontrolní vyšetření a dostupnost pacienta ......... 39

6.3 Data o pacientech ................................................39

Tabulka 6.3.1 Porovnání charakteristik subjektů ..................39

Tabulka 6.3.2 Distribuce průměru aneuryzmatu ..................39

6.4 Výsledky ......................................................... 39

Tabulka 6.4.1 Implantované zařízení .............................39

Tabulka 6.4.2 Primární výsledky. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Tabulka 6.4.3 Měřítka úspěšnosti ................................ 41

Tabulka 6.4.4 Radiografické nálezy v břišní oblasti –

integrita zařízení ................................................41

Tabulka 6.4.5 Nálezy na CT – průchodnost graftu ................41

Tabulka 6.4.6 Nálezy na CT – migrace graftu (hlavního těla) ...... 41

Tabulka 6.4.7 Radiografické nálezy v břišní oblasti –

separace větve ..................................................42

6.5 Léčba endoleaku .................................................42

Tabulka 6.5.1 Endoleaky (všechny typy, nové a perzistující) .......42

Tabulka 6.5.2 První výskyt endoleaku u pacientů se

standardním rizikem ............................................42

Tabulka 6.5.3 První výskyt endoleaku u pacientů s vysokým

rizikem .........................................................42

Tabulka 6.5.4 První výskyt endoleaku u roll-in pacientů ..........42

6.6 Změna aneuryzmatu .............................................43

Tabulka 6.6.1 Změna maximálního průměru aneuryzmatu

podle časového intervalu .......................................43

Tabulka 6.6.2 Změna velikosti aneuryzmatu a endoleaku

po 12 měsících ..................................................43

Tabulka 6.6.3 Změna velikosti aneuryzmatu a endoleaku

po 24 měsících ..................................................43

6.7 Sekundární intervence související s AAA .......................... 43

Tabulka 6.7.1 Sekundární intervence (do 12 měsíců) .............43

Tabulka 6.7.2 Sekundární intervence (>12 až 24 měsíců) .........43

6.8 Měření sekundárních výsledků. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Tabulka 6.8.1 Sekundární výsledky podle léčených skupin ........44

7 VÝBĚR A LÉČBA PACIENTA ..........................................44

Individualizace léčby .................................................44

8 PORADENSTVÍ PRO PACIENTY ......................................44

9 STAV PŘI DODÁNÍ ..................................................44

10 INFORMACE O KLINICKÉM POUŽITÍ ................................44

10.1 Školení lékařů ...................................................44

10.2 Kontrola před použitím .........................................44

10.3 Požadovaný materiál ............................................44

10.4 Doporučený materiál ............................................44

10.5 Pokyny k určení průměru zařízení. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Tabulka 10.5.1 Návod k měření průměru hlavního těla graftu .....45

Tabulka 10.5.2 Návod k měření průměru iliakálního ramena

graftu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

11 POKYNY K POUŽITÍ ...............................................45

Anatomické požadavky ................................................45

Obecné informace o použití ............................................45

Rozhodující činitele před implantací ....................................45

Příprava pacienta ......................................................45

11.1 Systém s bifurkací ...............................................45

11.1.1 Příprava a propláchnutí hlavního těla s bifurkací ...........45

11.1.2 Příprava a propláchnutí kontralaterálního iliakálního

ramena .........................................................45

11.1.3 Příprava a propláchnutí ipsilaterálního iliakálního

ramena .........................................................45

11.1.4 Cévní přístup a angiografie ............................... 45

11.1.5 Umístění hlavního těla ....................................45

11.1.6 Umístění vodicího drátu kontralaterální iliakální větve .....46

11.1.7 Rozvinutí proximální (horní) části hlavního těla ............46

11.1.8 Umístění a rozvinutí kontralaterálního iliakálního ramena ..46

11.1.9 Rozvinutí distální (dolní) části hlavního těla ...............46

11.1.10 Aretace horní čepičky ...................................46

11.1.11

Umístění a rozvinutí ipsilaterálního iliakálního ramena

11.1.12 Zavedení tvarovacího balónku ...........................46

Finální angiogram .......................................46

12 POKYNY K ZOBRAZOVÁNÍ A POOPERAČNÍ KONTROLE ..............46

12.1 Obecně .........................................................46

Tabulka 12.1 Doporučený plán zobrazovacích vyšetření pro

pacienty s endograftem .........................................47

12.2 Doporučení pro kontrastní a nekontrastní CT ....................47

Tabulka 12.2 Akceptovatelné zobrazovací protokoly .............47

12.3 Abdominální radiogramy ........................................47

12.4 Ultrazvuk ....................................................... 47

12.5 Bezpečnost a kompatibilita vyšetření MRI ........................47

12.6 Další sledování a léčba ..........................................47

13 INFORMACE PRO SLEDOVÁNÍ PACIENTŮ ...........................47

14 ŘEŠENÍ PROBLÉMŮ ..................................................47

14.1 Řešení problémů s uvolňovacím drátem ............................ 47

14.1.1 Rozvinutí proximální (horní) části hlavního těla ...................47

14.1.2 Aretace horní čepičky .............................................48

14.1.3 Umístění a rozvinutí ipsilaterálního iliakálního ramena ...........48

14.1.4 Umístění a rozvinutí kontralaterálního iliakálního ramena ........48

14.2 Řešení problémů s rozvinováním suprarenálního stentu .............48

14.2.1 Rozvinutí proximální (horní) části hlavního těla ...................48

14.2.2 Aretace horní čepičky .............................................48

14.2.3 Umístění a rozvinutí ipsilaterálního iliakálního ramena ...........48

14.2.4 Umístění a rozvinutí kontralaterálního iliakálního ramena ........48

......46

DANSK

INDHOLDSFORTEGNELSE

1 BESKRIVELSE AF PRODUKTET ........................................50

1.1 Komponenter til aortisk hovedprotese og til iliaca-ben ..............50

1.2 Hovedprotesens fremføringssystem ................................50

1.3 Fremføringssystem for iliaca-ben ...................................50

1.4 Tilbehørskomponenter til Zenith AAA endovaskulær protese ........50

2 TILSIGTET ANVENDELSE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50

3 KONTRAINDIKATIONER ..............................................50

4 ADVARSLER OG FORHOLDSREGLER ...................................50

4.1 Generelle ..........................................................50

4.2 Patientudvælgelse, behandling og opfølgning ....................

4.3 Måleteknik og billeddiagnostik før proceduren ....................

4.4 Udvælgelse af produkt ........................................... 51

4.5 Implantationsprocedure ..........................................51

4.6 Brug af formningsballon ..........................................51

4.7 Sikkerhed og kompatibilitet ved MR-scanning ......................

5 UØNSKEDE HÆNDELSER .............................................51

5.1 Observerede uønskede hændelser ..................................

Tabel 5.1.1 Død og ruptur fra klinisk undersøgelse .................

Tabel 5.1.2 Uønskede hændelser i klinisk undersøgelse ............52

5.2 Mulige uønskede hændelser. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52

Rapportering af uønskede hændelser, relateret til anordning .........52

6 RESUME OVER KLINISKE UNDERSØGELSER ............................52

6.1 Målsætning ........................................................52

6.2 Undersøgelsens design .............................................52

Tabel 6.2.1 Patientopfølgning og ansvarlighed .....................53

6.3 Demografiske oplysninger om patienter ............................53

Tabel 6.3.1 Sammenligning af forsøgspersoners karakteristika ......53

Tabel 6.3.2 Fordeling af aneurismets diameter .....................53

6.4 Resultater ..........................................................53

Tabel 6.4.1 Implanterede anordninger .............................53

Tabel 6.4.2 Primære resultater .....................................54

Tabel 6.4.3 Måltal for succes .......................................55

Tabel 6.4.4 Abdominale fund under røntgen –

Anordningens integritet ..........................................55

Tabel 6.4.5 CT fund – Åbenhed af protese .........................55

Tabel 6.4.6 CT fund – Migration af protese (hovedprotese) .........55

Tabel 6.4.7 Abdominale fund under røntgen – separation af lem ...56

6.5 Styring af endolækage .............................................56

Tabel 6.5.1 Endolækager (alle typer, nye og vedvarende) ...........56

Tabel 6.5.2 Første tilfælde af endolækage for

standardrisikopatienter ...........................................56

Tabel 6.5.3 Første tilfælde af endolækage for højrisikopatienter ....56

Tabel 6.5.4 Første tilfælde af endolækage for indlæringspatienter ..56

6.6 Aneurismeændring ................................................57

Tabel 6.6.1 Ændring i aneurismets maksimale diameter

efter interval ......................................................57

Tabel 6.6.2 Ændring af aneurismets størrelse og endolækage

ved 12 måneder ..................................................57

Tabel 6.6.3 Ændring af aneurismets størrelse og endolækage

ved 24 måneder ..................................................57

6.7 AAA-relaterede sekundære interventioner ..........................57

Tabel 6.7.1 Sekundære interventioner (til 12 måneder) .............57

Tabel 6.7.2 Sekundære interventioner (> 12 til 24 måneder) ........57

6.8 Måltal for sekundære resultater .....................................58

Tabel 6.8.1 Sekundære resultater efter behandlingsgruppe ........58

7 PATIENTUDVÆLGELSE OG BEHANDLING ..............................58

Individualisering af behandling ........................................58

8 PATIENTRÅDGIVNINGSINFORMATION .................................58

9 LEVERING ...........................................................58

10 INFORMATION OM KLINISK ANVENDELSE ............................58

10.1 Lægeuddannelse .................................................58

10.2 Inspektion inden brug ............................................58

10.3 Nødvendige materialer ............................................58

10.4 Anbefalede materialer ............................................58

10.5 Retningslinjer for størrelsesbestemmelse af produktdiameter ......59

Tabel 10.5.1 Størrelsesguide for hovedprotesens diameter .........59

Tabel 10.5.2 Størrelsesguide for iliaca-benprotesens diameter ......59

11 VEJLEDNING .......................................................59

Anatomiske krav .......................................................59

Generel information om anvendelse ...................................59

Afgørende faktorer før implantation ....................................59

Klargøring af patienten ................................................59

11.1 Bifurkationssystem ................................................59

11.1.1 Forberedelse/skylning af bifurkationshovedprotese .........59

11.1.2 Forberedelse/skylning af kontralateral iliaca-ben ............59

11.1.3 Forberedelse/skylning af ipsilateral iliaca-ben ...............59

11.1.4 Vaskulær adgang og angiografi .............................59

11.1.5 Placering af hovedprotese ..................................59

11.1.6 Placering af den kontralaterale iliaca-kateterleder ...........59

11.1.7 Proksimal (top) anlæggelse af hovedprotese ................60

11.1.8 Placering og anlæggelse af kontralateral iliaca-ben ..........60

11.1.9 Distal (bund) anlæggelse af hovedprotese ..................60

11.1.10 Sammenkobling af tophætten .............................60

11.1.11 Placering og anlæggelse af ipsilateral iliaca-ben ............60

11.1.12 Indføring af formningsballon ..............................60

Slutangiogram .............................................60

12 RETNINGSLINJER FOR BILLEDDIAGNOSTIK OG POSTOPERATIV

OPFØLGNING ......................................................60

12.1 Generelle .........................................................60

Tabel 12.1 Anbefalet billeddiagnostisk plan for

endoprotesepatienter .............................................61

12.2 Anbefalinger for CT-scanning med og uden kontrast ...............61

Tabel 12.2 Acceptable billeddiagnostiske protokoller ..............61

12.3 Abdominale røntgenbilleder ......................................61

12.4 Ultralydsscanning .................................................61

12.5 Sikkerhed og kompatibilitet ved MR-scanning .....................61

12.6 Yderligere kontrol og behandling ..................................61

13 OPLYSNINGER OM SPORING AF PATIENTER ..........................61

14 FEJLSØGNING .......................................................61

14.1 Fejlfinding ved udløser-wirens frigørelse ............................61

14.1.1 Proksimal (top) anlæggelse af hovedprotese. . . . . . . . . . . . . . . . . . . . . .61

14.1.2 Sammenkobling af tophætten ....................................62

14.1.3 Placering og anlæggelse af ipsilateral iliaca-ben ..................62

14.1.4 Placering og anlæggelse af kontralateral iliaca-ben ...............62

14.2 Fejlfinding ved anlæggelse af den suprarenale stent ................ 62

14.2.1 Proksimal (top) anlæggelse af hovedprotese. . . . . . . . . . . . . . . . . . . . . .62

14.2.2 Sammenkobling af tophætten ....................................62

14.2.3 Placering og anlæggelse af ipsilateral iliaca-ben ..................62

14.2.4 Placering og anlæggelse af kontralateral iliaca-ben ...............62

DEUTSCH

INHALTSVERZEICHNIS

1 BESCHREIBUNG DES INSTRUMENTS ..................................64

1.1 Hauptteil (Aortenteil) und iliakale Schenkel .........................64

1.2 Einführsystem für Hauptteil ........................................64

1.3 Einführsystem für iliakale Schenkel .................................64

1.4 Hilfskomponenten für die endovaskuläre AAA-Prothese Zenith ......64

2 VERWENDUNGSZWECK ..............................................64

3 KONTRAINDIKATIONEN ..............................................64

4 WARNHINWEISE UND VORSICHTSMASSNAHMEN ......................64

4.1 Allgemeines .......................................................64

4.2 Auswahl, Behandlung und Nachsorge der Patienten ..............

4.3 Messtechniken und Bildgebung vor dem Eingriff ..................

4.4 Auswahl der Prothese ............................................65

4.5 Implantationsverfahren ..........................................65

4.6 Verwendung des Modellierungsballons ...........................65

4.7 Sicherheit und Kompatibilität mit MRT ..............................65

5 UNERWÜNSCHTE EREIGNISSE ........................................65

5.1 Beobachtete unerwünschte Ereignisse ..............................65

Tabelle 5.1.1 Todesfälle und Rupturen in der klinischen Studie .....65

Tabelle 5.1.2 Unerwünschte Ereignisse in der klinischen Studie .....66

5.2 Mögliche unerwünschte Ereignisse .................................66

Bericht zu prothesenbezogenen unerwünschten Ereignissen .........66

6 ZUSAMMENFASSUNG DER KLINISCHEN STUDIEN ......................66

6.1 Ziele ...............................................................66

6.2 Studiendesign .....................................................66

Tabelle 6.2.1 Patientennachsorge und Verantwortlichkeiten ........67

6.3 Patientendemographische Daten ...................................67

Tabelle 6.3.1 Vergleich der Patientenmerkmale ....................67

Tabelle 6.3.2 Ver teilung der Aneurysmadurchmesser ...............67

6.4 Ergebnisse .........................................................67

Tabelle 6.4.1 Implantierte Geräte ..................................68

Tabelle 6.4.2 Primärergebnisse ....................................68

Tabelle 6.4.3 Erfolgsmaßstäbe .....................................69

Tabelle 6.4.4 Abdominale Röntgenbefunde – Unversehrtheit

der Prothese ......................................................69

Tabelle 6.4.5 CT-Befunde – Durchgängigkeit der Prothese ..........69

Tabelle 6.4.6 CT-Befunde – Migration der Prothese (Hauptteil) ......69

Tabelle 6.4.7 Abdominale Röntgenbefunde – Ansatzablösung. . . . . .70

6.5 Endoleak-Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70

Tabelle 6.5.1 Endoleaks (alle Typen, neu und persistierend) .........70

Tabelle 6.5.2 Erstes Auftreten eines Endoleaks bei

Standardrisikopatienten ..........................................70

Tabelle 6.5.3 Erstes Auftreten eines Endoleaks bei

Hochrisikopatienten ..............................................70

Tabelle 6.5.4 Erstes Auftreten eines Endoleaks bei Studienpatienten ...70

6.6 Aneurysmaänderungen ............................................71

Tabelle 6.6.1 Änderungen des maximalen

Aneurysmadurchmessers nach Intervall ...........................71

Tabelle 6.6.2 Änderung der Aneurysmagröße und

Endoleak nach 12 Monaten .......................................71

Tabelle 6.6.3 Änderung der Aneurysmagröße und

Endoleak nach 24 Monaten .......................................71

6.7 AAA-bezogene Sekundärinterventionen ............................71

Tabelle 6.7.1 Sekundäre Interventionen (bis 12 Monate) ............71

Tabelle 6.7.2 Sekundäre Interventionen (> 12 bis 24 Monate) .......71

6.8 Maßstäbe für sekundäre Ergebnisse ................................72

Tabelle 6.8.1 Sekundäre Ergebnisse nach Behandlungsgruppe .....72

7 AUSWAHL UND BEHANDLUNG DER PATIENTEN. . . . . . . . . . . . . . . . . . . . . . . .72

Individuelle Gestaltung der Behandlung ...............................72

8 INFORMATIONEN ZUR AUFKLÄRUNG DES PATIENTEN ..................72

9 LIEFERFORM ........................................................72

10 INFORMATIONEN ZUM KLINISCHEN EINSATZ .........................72

10.1 Ärzteschulung ....................................................72

10.2 Überprüfung vor dem Gebrauch ..................................72

10.3 Erforderliche Materialien ..........................................72

10.4 Empfohlene Materialien ...........................................72

10.5 Richtlinien zur Bestimmung des Prothesendurchmessers ...........73

Tabelle 10.5.1 Anleitung zur Bestimmung des Durchmessers

des Prothesenhauptteils ...........................................73

Tabelle 10.5.2 Anleitung zur Bestimmung des Durchmessers

des iliakalen Prothesenschenkels ..................................73

11 GEBRAUCHSANWEISUNG ...........................................73

Anatomische Voraussetzungen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

Allgemeine Informationen zum Gebrauch ..............................73

Die Präimplantationsphase bestimmende Faktoren .....................73

Vorbereitung des Patienten ............................................73

11.1 Gegabeltes System ................................................73

11.1.1 Vorbereitung/Spülen des gegabelten Hauptteils ............73

11.1.2 Vorbereitung/Spülen des kontralateralen iliakalen

Schenkels ........................................................73

11.1.3 Vorbereitung/Spülen des ipsilateralen iliakalen

Schenkels ........................................................73

11.1.4 Gefäßzugang und Angiographie ............................73

11.1.5 Positionieren des Hauptteils ................................73

11.1.6 Positionieren des kontralateralen iliakalen Führungsdrahts ..74

11.1.7

Entfalten des proximalen (oberen) Hauptkörpers

11.1.8 Positionieren und Entfalten des kontralateralen iliakalen

Schenkels ........................................................74

11.1.9 Entfalten des distalen (untersten) Stents des Hauptteils .....74

11.1.10 Andocken der oberen Kappe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74

11.1.11 Positionieren und Entfalten des ipsilateralen iliakalen

Schenkels ........................................................74

11.1.12 Einführen des Modellierungsballons .......................74

Abschließendes Angiogramm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

12 RICHTLINIEN FÜR DIE BILDGEBUNG UND POSTOPERATIVE

NACHSORGE .......................................................75

12.1 Allgemeines ......................................................75

Tabelle 12.1 Empfohlener Bildgebungsplan für Patienten mit

Endoprothese ....................................................75

12.2 Empfehlungen für CT mit und ohne Kontrastmittel ................75

Tabelle 12.2 Akzeptable Bildgebungsprotokolle ...................75

12.3 Röntgenaufnahmen des Abdomens ...............................75

12.4 Ultraschall ........................................................75

12.5 Sicherheit und Kompatibilität mit MRT ............................75

12.6 Zusätzliche Überwachung und Behandlung .......................76

13 INFORMATIONEN ZUR PATIENTENVERFOLGUNG .....................76

14 FEHLERBEHEBUNG ...................................................76

14.1 Fehlerbehebung am Auslösedrahtmechanismus ....................76

14.1.1 Entfalten des proximalen (oberen) Hauptkörpers .................76

14.1.2 Andocken der oberen Kappe .....................................76

14.1.3 Positionieren und Entfalten des ipsilateralen iliakalen Schenkels .76

14.1.4 Positionieren und Entfalten des kontralateralen iliakalen

Schenkels ................................................................76

14.2 Fehlerbehebung bei der suprarenalen Stententfaltung ..............76

14.2.1 Entfalten des proximalen (oberen) Hauptkörpers .................76

14.2.2 Andocken der oberen Kappe .....................................77

14.2.3 Positionieren und Entfalten des ipsilateralen iliakalen Schenkels .77

14.2.4 Positionieren und Entfalten des kontralateralen iliakalen

Schenkels ................................................................77

.............74

64 64

ΕΛΛΗΝΙΚΑ

ΠΙΝΑΚΑΣ ΠΕΡΙΕΧΟΜΕΝΩΝ

1 ΠΕΡΙΓΡΑΦΗ ΤΗΣ ΣΥΣΚΕΥΗΣ ..........................................78

1.1 Εξαρτήματα αορτικού κύριου σώματος και λαγόνιου σκέλους .......78

1.2 Σύστημα τοποθέτησης κύριου σώματος ............................78

1.3 Σύστημα τοποθέτησης λαγόνιου σκέλους ...........................78

1.4 Βοηθητικά εξαρτήματα ενδαγγειακού μοσχεύματος AAA Zenith .....78

2 ΧΡΗΣΗ ΓΙΑ ΤΗΝ ΟΠΟΙΑ ΠΡΟΟΡΙΖΕΤΑΙ .................................78

3 ΑΝΤΕΝΔΕΙΞΕΙΣ ......................................................78

4 ΠΡΟΕΙΔΟΠΟΙΗΣΕΙΣ ΚΑΙ ΠΡΟΦΥΛΑΞΕΙΣ ................................78

4.1 Γενικά .............................................................78

4.2 Επιλογή, θεραπεία και παρακολούθηση ασθενούς .................

4.3 Τεχνικές μέτρησης και απεικόνιση πριν από τη διαδικασία .........

4.4 Επιλογή συσκευής ................................................79

4.5 Διαδικασία εμφύτευσης .......................................... 79

4.6 Χρήση μπαλονιού διαμόρφωσης .................................79

4.7 Ασφάλεια και συμβατότητα με μαγνητική τομογραφία (MRI) .........

5 ΑΝΕΠΙΘΥΜΗΤΕΣ ΕΝΕΡΓΕΙΕΣ ..........................................79

5.1 Παρατηρούμενες ανεπιθύμητες ενέργειες ...........................

Πίνακας 5.1.1 Θάνατος και ρήξη από την κλινική μελέτη ...........80

Πίνακας 5.1.2 Ανεπιθύμητες ενέργειες στην κλινική μελέτη .........80

5.2 Δυνητικές ανεπιθύμητες ενέργειες ..................................80

Αναφορά ανεπιθύμητων ενεργειών που σχετίζονται με

τη συσκευή .........................................................80

6 ΠΕΡΙΛΗΨΗ ΤΩΝ ΚΛΙΝΙΚΩΝ ΜΕΛΕΤΩΝ. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80

6.1 Στόχοι .............................................................80

6.2 Σχεδιασμός της μελέτης ............................................80

Πίνακας 6.2.1 Παρακολούθηση και υπευθυνότητα ασθενών ........81

6.3 Δημογραφικά στοιχεία των ασθενών ................................81

Πίνακας 6.3.1 Σύγκριση των χαρακτηριστικών των ασθενών .......81

Πίνακας 6.3.2 Κατανομή διαμέτρων ανευρύσματος ................81

6.4 Αποτελέσματα .....................................................81

Πίνακας 6.4.1 Συσκευές που εμφυτεύτηκαν ........................82

Πίνακας 6.4.2 Πρωτεύοντα αποτελέσματα .........................82

Πίνακας 6.4.3 Μετρήσεις επιτυχίας. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

Πίνακας 6.4.4 Κοιλιακά ακτινογραφικά ευρήματα –

Ακεραιότητα της συσκευής. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

Πίνακας 6.4.5 Ευρήματα αξονικής τομογραφίας –

Βατότητα μοσχεύματος ...........................................83

Πίνακας 6.4.6 Ευρήματα αξονικής τομογραφίας –

Μετανάστευση μοσχεύματος (κύριο σώμα) ........................83

Πίνακας 6.4.7 Κοιλιακά ακτινογραφικά ευρήματα –

Διαχωρισμός μέλους ..............................................84

6.5 Διαχείριση ενδοδιαφυγής ..........................................84

Πίνακας 6.5.1 Ενδοδιαφυγές (Όλοι οι τύποι, νέες και επίμονες). . . . . .84

Πίνακας 6.5.2 Πρώτη εμφάνιση ενδοδιαφυγής για ασθενείς

τυπικού κινδύνου .................................................84

Πίνακας 6.5.3 Πρώτη εμφάνιση ενδοδιαφυγής για ασθενείς

υψηλού κινδύνου .................................................84

Πίνακας 6.5.4 Πρώτη εμφάνιση ενδοδιαφυγής για ασθενείς

εισαγωγικής περιόδου ............................................84

6.6 Μεταβολή ανευρύσματος ..........................................85

Πίνακας 6.6.1 Μεταβολή στη μέγιστη διάμετρο ανευρύσματος

κατά διάστημα ....................................................85

Πίνακας 6.6.2 Μεταβολή στο μέγεθος του ανευρύσματος και

ενδοδιαφυγή στους 12 μήνες .....................................85

Πίνακας 6.6.3 Μεταβολή στο μέγεθος του ανευρύσματος και

ενδοδιαφυγή στους 24 μήνες .....................................85

6.7 Δευτερεύουσες επεμβάσεις που σχετίζονται με AAA ................85

Πίνακας 6.7.1 Δευτερεύουσες επεμβάσεις (έως 12 μήνες) ..........85

Πίνακας 6.7.2 Δευτερεύουσες επεμβάσεις (>12 έως 24 μήνες) ......85

6.8 Μετρήσεις δευτερεύουσας έκβασης ................................86

Πίνακας 6.8.1 Δευτερεύουσες εκβάσεις κατά ομάδα θεραπείας .....86

7 ΕΠΙΛΟΓΗ ΚΑΙ ΘΕΡΑΠΕΙΑ ΑΣΘΕΝΩΝ ...................................86

Εξατομίκευση της θεραπείας ...........................................86

8 ΠΛΗΡΟΦΟΡΙΕΣ ΓΙΑ ΤΙΣ ΣΥΣΤΑΣΕΙΣ ΠΡΟΣ ΤΟΝ ΑΣΘΕΝΗ ................86

9 ΤΡΟΠΟΣ ΔΙΑΘΕΣΗΣ ..................................................86

10 ΠΛΗΡΟΦΟΡΙΕΣ ΓΙΑ ΤΗΝ ΚΛΙΝΙΚΗ ΧΡΗΣΗ ............................86

10.1 Εκπαίδευση ιατρού ...............................................86

10.2 Επιθεώρηση πριν από τη χρήση ...................................86

10.3 Απαιτούμενα υλικά ................................................86

10.4 Συνιστώμενα υλικά ................................................86

10.5 Κατευθυντήριες οδηγίες προσδιορισμού μεγέθους διαμέτρου

συσκευής ..............................................................87

Πίνακας 10.5.1 Οδηγός προσδιορισμού μεγέθους διαμέτρου

μοσχεύματος κύριου σώματος ....................................87

Πίνακας 10.5.2 Οδηγός προσδιορισμού μεγέθους διαμέτρου

μοσχεύματος λαγόνιου σκέλους ...................................87

11 ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ ..................................................87

Ανατομικές απαιτήσεις .................................................87

Γενικές πληροφορίες χρήσης ...........................................87

Προσδιοριστικοί παράγοντες προ της εμφύτευσης .....................87

Προετοιμασία ασθενούς ...............................................87

11.1 Διχαλωτό σύστημα ................................................87

11.1.1 Προετοιμασία/Έκπλυση διχαλωτού κύριου σώματος ........87

11.1.2 Προετοιμασία/Έκπλυση ετερόπλευρου λαγόνιου σκέλους ...87

11.1.3 Προετοιμασία/Έκπλυση σύστοιχου λαγόνιου σκέλους .......87

11.1.4 Αγγειακή προσπέλαση και αγγειογραφία ....................87

11.1.5 Τοποθέτηση κύριου σώματος ...............................87

11.1.6 Τοποθέτηση του ετερόπλευρου λαγόνιου συρμάτινου

οδηγού ...........................................................88

11.1.7 Εγγύς (άνω) απελευθέρωση του κύριου σώματος ............88

11.1.8 Τοποθέτηση και απελευθέρωση του ετερόπλευρου λαγόνιου

σκέλους ..........................................................88

11.1.9 Περιφερική (κάτω) απελευθέρωση του κύριου σώματος .....88

11.1.10 Σύνδεση του άνω πώματος ................................88

11.1.11 Τοποθέτηση και απελευθέρωση του σύστοιχου λαγόνιου

σκέλους ..........................................................88

11.1.12 Εισαγωγή μπαλονιού διαμόρφωσης .......................88

Τελικό αγγειόγραμμα ......................................89

12 ΚΑΤΕΥΘΥΝΤΗΡΙΕΣ ΟΔΗΓΙΕΣ ΑΠΕΙΚΟΝΙΣΗΣ ΚΑΙ ΜΕΤΕΓΧΕΙΡΗΤΙΚΗ

ΠΑΡΑΚΟΛΟΥΘΗΣΗ .................................................89

12.1 Γενικά ............................................................89

Πίνακας 12.1 Συνιστώμενο πρόγραμμα απεικόνισης για

ασθενείς με ενδαγγειακό μόσχευμα ...............................89

12.2 Συστάσεις αξονικής τομογραφίας με και χωρίς

σκιαγραφικό μέσο ................................................89

Πίνακας 12.2 Αποδεκτά πρωτόκολλα απεικόνισης ..................89

12.3 Κοιλιακές ακτινογραφίες ..........................................89

12.4 Υπέρηχος .........................................................89

12.5 Ασφάλεια και συμβατότητα με μαγνητική τομογραφία (MRI) .......89

12.6 Επιπλέον παρακολούθηση και θεραπεία ...........................90

13 ΠΛΗΡΟΦΟΡΙΕΣ ΠΑΡΑΚΟΛΟΥΘΗΣΗΣ ΑΣΘΕΝΩΝ ......................90

14 ΑΝΤΙΜΕΤΩΠΙΣΗ ΠΡΟΒΛΗΜΑΤΩΝ .................................... 90

14.1 Αντιμετώπιση προβλημάτων με την απελευθέρωση του σύρματος

ενεργοποίησης .......................................................... 90

14.1.1 Εγγύς (άνω) απελευθέρωση του κύριου σώματος ............. 90

14.1.2 Σύνδεση του άνω πώματος ..................................90

14.1.3 Τοποθέτηση και απελευθέρωση σύστοιχου λαγόνιου σκέλους .. 90

14.1.4 Τοποθέτηση και απελευθέρωση ετερόπλευρου λαγόνιου

σκέλους ............................................................ 90

14.2 Αντιμετώπιση προβλημάτων απελευθέρωσης της επινεφρικής

ενδοπρόσθεσης ......................................................... 91

14.2.1 Εγγύς (άνω) απελευθέρωση του κύριου σώματος ............. 91

14.2.2 Σύνδεση του άνω πώματος ..................................91

14.2.3 Τοποθέτηση και απελευθέρωση σύστοιχου λαγόνιου σκέλους 91

14.2.4 Τοποθέτηση και απελευθέρωση ετερόπλευρου λαγόνιου

σκέλους ............................................................ 91

ESPAÑOL

ÍNDICE

1 DESCRIPCIÓN DEL DISPOSITIVO ......................................92

1.1 Cuerpo principal aórtico y ramas ilíacas .............................92

1.2 Sistema de implantación del cuerpo principal .......................92

1.3 Sistema de implantación de la rama ilíaca ...........................92

1.4 Componentes auxiliares de la endoprótesis vascular para

AAA Zenith ............................................................92

2 INDICACIONES ......................................................92

3 CONTRAINDICACIONES ..............................................92

4 ADVERTENCIAS Y PRECAUCIONES ....................................92

4.1 Generales .........................................................92

4.2 Selección, tratamiento y seguimiento de los pacientes ............

4.3 Técnicas de medición y estudios de imagen previos

al procedimiento ....................................................

4.4 Selección de los dispositivos ......................................93

4.5 Procedimiento de implantación ..................................93

4.6 Uso del balón moldeador .........................................93

4.7 Seguridad y compatibilidad con MRI ................................

5 REACCIONES ADVERSAS .............................................93

5.1 Reacciones adversas observadas ....................................

Tabla 5.1.1 Muertes y roturas observadas en el estudio clínico ......

Tabla 5.1.2 Reacciones adversas observadas en el estudio clínico ...94

5.2 Reacciones adversas posibles .......................................94

Informes de reacciones adversas relacionadas con el dispositivo ......94

6 RESUMEN DE ESTUDIOS CLÍNICOS ....................................94

6.1 Objetivos ..........................................................94

6.2 Diseño del estudio .................................................94

Tabla 6.2.1 Seguimiento y disponibilidad de los pacientes. . . . . . . . . .95

6.3 Datos demográficos de los pacientes ...............................95

Tabla 6.3.1 Comparación de las características de los sujetos .......95

Tabla 6.3.2 Distribución de los diámetros de los aneurismas ........95

6.4 Resultados .........................................................95

Tabla 6.4.1 Dispositivos implantados ..............................96

Tabla 6.4.2 Resultados primarios. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96

Tabla 6.4.3 Medidas de éxito ......................................97

Tabla 6.4.4 Resultados radiográficos abdominales: integridad

del dispositivo ....................................................97

Tabla 6.4.5 Resultados de las TAC: permeabilidad de la

endoprótesis vascular .............................................97

Tabla 6.4.6 Resultados de las TAC: migración de la endoprótesis

vascular (cuerpo principal) ........................................97

Tabla 6.4.7 Resultados radiográficos abdominales: separación

de las ramificaciones ..............................................98

6.5 Tratamiento de las endofugas ......................................98

Tabla 6.5.1 Endofugas (todos los tipos, nuevas y persistentes) ......98

Tabla 6.5.2 Primera aparición de una endofuga en pacientes

de riesgo normal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98

Tabla 6.5.3 Primera aparición de una endofuga en pacientes

de alto riesgo .....................................................98

Tabla 6.5.4 Primera aparición de una endofuga en pacientes

de prueba ........................................................98

6.6 Cambio del aneurisma .............................................99

Tabla 6.6.1 Cambio del diámetro máximo del aneurisma

por intervalos .....................................................99

Tabla 6.6.2 Cambio del tamaño del aneurisma y endofugas

a los 12 meses ....................................................99

Tabla 6.6.3 Cambio del tamaño del aneurisma y endofugas

a los 24 meses ....................................................99

6.7 Intervenciones secundarias relacionadas con el AAA ................99

Tabla 6.7.1 Intervenciones secundarias (hasta los 12 meses) ........99

Tabla 6.7.2 Intervenciones secundarias (desde los 12 hasta

los 24 meses) .....................................................99

6.8 Medidas de los resultados secundarios ........................... 100

Tabla 6.8.1 Resultados de las intervenciones secundarias por

grupo de tratamiento ........................................... 100

7 SELECCIÓN Y TRATAMIENTO DE LOS PACIENTES ..................... 100

Individualización del tratamiento ....................................100

8 INFORMACIÓN PARA EL ASESORAMIENTO DE LOS PACIENTES. . . . . . . . 100

9 PRESENTACIÓN ....................................................100

10 INFORMACIÓN SOBRE EL USO CLÍNICO ............................100

10.1 Formación de médicos .......................................... 100

10.2 Inspección previa al uso ......................................... 100

10.3 Material necesario ..............................................100

10.4 Material recomendado .......................................... 100

10.5 Pautas para la selección del diámetro de los dispositivos ......... 101

Tabla 10.5.1 Guía para la selección del diámetro del cuerpo

principal ........................................................ 101

Tabla 10.5.2 Guía para la selección del diámetro de las ramas

ilíacas. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

11 MODO DE EMPLEO ............................................... 101

Requisitos anatómicos ............................................... 101

Información general sobre el uso ..................................... 101

Factores determinantes previos al implante .......................... 101

Preparación del paciente ............................................. 101

11.1 Sistema bifurcado ............................................... 101

11.1.1 Preparación y lavado del cuerpo principal bifurcado ....... 101

11.1.2 Preparación y lavado de la rama ilíaca contralateral. . . . . . . . 101

11.1.3 Preparación y lavado de la rama ilíaca ipsilateral. . . . . . . . . . . 101

11.1.4 Acceso vascular y angiografía ............................. 101

11.1.5 Colocación del cuerpo principal ..........................101

11.1.6 Colocación de la guía ilíaca contralateral .................. 102

11.1.7 Despliegue proximal (parte superior) del cuerpo principal . 102

11.1.8 Colocación y despliegue de la rama ilíaca contralateral .... 102

11.1.9 Despliegue distal (parte inferior) del cuerpo principal .....102

11.1.10 Acoplamiento de la cápsula superior ....................102

11.1.11 Colocación y despliegue de la rama ilíaca ipsilateral ...... 102

11.1.12 Introducción del balón moldeador. . . . . . . . . . . . . . . . . . . . . . . 102

Angiografía final ......................................... 102

12 PAUTAS PARA LOS ESTUDIOS DE IMAGEN Y SEGUIMIENTO

POSOPERATORIO .................................................103

12.1 Generales ....................................................... 103

Tabla 12.1 Programa de estudios de imagen recomendado para

pacientes con endoprótesis vasculares .......................... 103

12.2 Recomendaciones para la TAC con contraste y sin él ............. 103

Tabla 12.2 Protocolos válidos de estudios de imagen ............ 103

12.3 Radiografías abdominales ....................................... 103

12.4 Ecografía .......................................................103

12.5 Seguridad y compatibilidad con MRI ............................ 103

12.6 Vigilancia y tratamiento adicionales ............................. 104

13 INFORMACIÓN PARA LA LOCALIZACIÓN DEL PACIENTE .............104

14 SOLUCIÓN DE PROBLEMAS .........................................104

14.1 Solución de problemas de liberación mediante alambre disparador . 104

14.1.1 Despliegue proximal (parte superior) del cuerpo principal ...104

14.1.2 Acoplamiento de la cápsula superior ........................104

14.1.3 Colocación y despliegue de la rama ilíaca ipsilateral .........104

14.1.4 Colocación y despliegue de la rama ilíaca contralateral ......104

14.2 Solución de problemas de despliegue del stent suprarrenal ........104

14.2.1 Despliegue proximal (parte superior) del cuerpo principal ...104

14.2.2 Acoplamiento de la cápsula superior ........................105

14.2.3 Colocación y despliegue de la rama ilíaca ipsilateral .........105

14.2.4 Colocación y despliegue de la rama ilíaca contralateral ......105

93 93

FRANÇAIS

TABLE DES MATIÈRES

1 DESCRIPTION DU DISPOSITIF ....................................... 106

1.1 Corps principal aortique et composants de branches iliaques ..... 106

1.2 Système de largage du corps principal ............................ 106

1.3 Système de largage de la branche iliaque ......................... 106

1.4 Composants auxiliaires de l’endoprothèse Zenith AAA ............106

2 UTILISATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

3 CONTRE-INDICATIONS .............................................106

4 AVERTISSEMENTS ET MISES EN GARDE .............................106

4.1 Généralités ....................................................... 106

4.2 Sélection, traitement et suivi des patients ........................

4.3 Techniques de mesure et imagerie avant l’intervention ...........

4.4 Sélection des dispositifs .........................................107

4.5 Méthode d’implantation .........................................107

4.6 Utilisation du ballonnet de modelage ............................107

4.7 Sécurité d’emploi et compatibilité IRM ............................

5 ÉVÉNEMENTS INDÉSIRABLES ....................................... 107

5.1 Événements indésirables observés ................................

Tableau 5.1.1 Décès et ruptures survenus dans l’étude clinique ... 108

Tableau 5.1.2 Événements indésirables dans l’étude clinique ..... 108

5.2 Événements indésirables possibles ............................... 108

Rapport d’événement indésirable associé au dispositif. . . . . . . . . . . . . . .108

6 SOMMAIRE DES ÉTUDES CLINIQUES ................................ 108

6.1 Objectifs ......................................................... 108

6.2 Modèle de l’étude ................................................ 108

Tableau 6.2.1 Suivi et bilan post-opératoire des patients ......... 109

6.3 Données démographiques des patients. . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Tableau 6.3.1 Comparaison des caractéristiques des patients .....109

Tableau 6.3.2 Distribution des diamètres d’anévrisme ............109

6.4 Résultats ......................................................... 109

Tableau 6.4.1 Dispositifs implantés .............................. 110

Tableau 6.4.2 Résultats principaux ............................... 110

Tableau 6.4.3 Critères de réussite ................................111

Tableau 6.4.4 Résultats des radiographies abdominales -

Intégrité du dispositif ........................................... 111

Tableau 6.4.5 Résultats TDM - Perméabilité de l’endoprothèse ....111

Tableau 6.4.6 Résultats TDM - Migration de l’endoprothèse

(corps principal) ................................................ 111

Tableau 6.4.7 Résultats des radiographies abdominales -

Séparation d’un membre. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

6.5 Prise en charge des endofuites ................................... 112

Tableau 6.5.1 Endofuites (tous types confondus, nouvelles

et persistantes) ................................................. 112

Tableau 6.5.2 Première survenue d’endofuite chez les patients

à risque standard ............................................... 112

Tableau 6.5.3 Première survenue d’endofuite chez les patients

à haut risque ................................................... 112

Tableau 6.5.4 Première survenue d’endofuite chez les patients

non randomisés ................................................112

6.6 Changement de taille de l’anévrisme ............................. 113

Tableau 6.6.1 Changement de diamètre maximum de

l’anévrisme par intervalle .......................................113

Tableau 6.6.2 Changement de taille de l’anévrisme et

endofuite à 12 mois ............................................. 113

Tableau 6.6.3 Changement de taille de l’anévrisme et

endofuite à 24 mois ............................................. 113

6.7 Interventions de seconde intention en rapport avec l’AAA .........113

Tableau 6.7.1 Interventions de seconde intention

(jusqu’à 12 mois). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Tableau 6.7.2 Interventions de seconde intention

(entre 12 et 24 mois) ............................................ 113

6.8 Mesures des résultats secondaires ................................ 114

Tableau 6.8.1 Résultats secondaires par groupe de traitement ....114

7 SÉLECTION ET TRAITEMENT DES PATIENTS .......................... 114

Individualisation du traitement ...................................... 114

8 CONSEILS AUX PATIENTS ...........................................114

9 PRÉSENTATION ....................................................114

10 UTILISATION CLINIQUE ........................................... 114

10.1 Formation clinique .............................................. 114

10.2 Inspection avant l’utilisation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

10.3 Matériel requis .................................................. 114

10.4 Matériel recommandé ........................................... 114

10.5 Directives de mesures relatives au diamètre des dispositifs ....... 115

Tableau 10.5.1 Guide de mesures du diamètre du corps principal 115 Tableau 10.5.2 Guide de mesure du diamètre de la branche

iliaque .......................................................... 115

11 DIRECTIVES D’UTILISATION ....................................... 115

Exigences anatomiques .............................................. 115

Informations générales sur l’utilisation ............................... 115

Facteurs déterminants avant l’implantation ...........................115

Préparation du patient ............................................... 115

11.1 Système bifurqué ............................................... 115

11.1.1 Préparation et rinçage du corps principal bifurqué ........ 115

11.1.2 Préparation et rinçage de la branche iliaque controlatérale ..

11.1.3 Préparation et rinçage de la branche iliaque homolatérale ..

11.1.4 Accès vasculaire et angiographie ......................... 115

11.1.5 Mise en place du corps principal .......................... 115

11.1.6 Mise en place du guide iliaque controlatéral .............. 116

11.1.7 Déploiement du stent proximal (supérieur) du corps

principal ........................................................ 116

11.1.8

Mise en place et déploiement du jambage iliaque

controlatéral

11.1.9 Déploiement du stent distal (inférieur) du corps principal . 116

11.1.10 Raccordement du capuchon supérieur ................... 116

11.1.11 homolatéral

11.1.12 Insertion du ballonnet de modelage ..................... 116

Angiographie finale .....................................117

12 DIRECTIVES D’IMAGERIE ET SUIVI POST-OPÉRATOIRE ............... 117

12.1 Généralités ..................................................... 117

Tableau 12.1 Planification d’imagerie recommandée pour

les patients porteurs d’une endoprothèse ....................... 117

12.2 Recommandations de TDM avec et sans injection de produit

de contraste .................................................... 117

Tableau 12.2 Protocoles d’imagerie agréés ....................... 117

12.3 Radiographies abdominales ..................................... 117

12.4 Échographie .................................................... 117

12.5 Sécurité d’emploi et compatibilité IRM ...........................117

12.6 Surveillance et traitement complémentaires ..................... 118

13 INFORMATIONS RELATIVES AU SUIVI DU PATIENT .................. 118

14 DÉPANNAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118

14.1 Dépannage du mécanisme de largage des fils de sécurité ..........118

14.1.1 Déploiement du stent proximal (supérieur) du corps principal . 118

14.1.2 Raccordement du capuchon supérieur ......................... 118

14.1.3 Mise en place et déploiement du jambage iliaque homolatéral 118

14.1.4 Mise en place et déploiement du jambage iliaque

controlatéral .......................................................... 118

14.2 Dépannage lors du déploiement du stent suprarénal ..............118

14.2.1 Déploiement du stent proximal (supérieur) du corps principal . 118

14.2.2 Raccordement du capuchon supérieur ......................... 119

14.2.3 Mise en place et déploiement du jambage iliaque homolatéral 119

14.2.4 Mise en place et déploiement du jambage iliaque controlatéral 119

.................................................... 116

Mise en place et déploiement du jambage iliaque

..................................................... 116

106 106

107

115 115

MAGYAR

TARTALOMJEGYZÉK

1 AZ ESZKÖZ LEÍRÁSA ..............................................120

1.1 Aortikus fő graft-törzs és iliaca-szár komponenesek ..............120

1.2 A fő graft-törzs bejuttatórendszere ..............................120

1.3 Az iliaca-szár bejuttatórendszere .................................120

1.4 A Zenith AAA endovaszkuláris graft tartozékai ...................120

2 HASZNÁLATI JAVALLATOK ........................................120

3 ELLENJAVALLATOK ...............................................120

4 FIGYELMEZTETÉSEK ÉS ÓVINTÉZKEDÉSEK .........................120

4.1 Általános. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.2 A betegek kiválasztása, kezelése és utánkövetése ................120

4.3 A beavatkozást megelőzően alkalmazott mérési technikák

és leképezés ........................................................120

4.4 Az eszköz kiválasztása ...........................................121

4.5 Beültetési eljárás ................................................121

4.6 A formázóballon használata .....................................121

4.7 MRI-biztonság és -kompatibilitás .................................

5 NEMKÍVÁNATOS ESEMÉNYEK ......................................121

5.1 Megfigyelt nemkívánatos események ............................121

5.1.1. táblázat. A klinikai vizsgálatban előfordult halálesetek

és ruptúrák ....................................................121

5.1.2. táblázat. A klinikai vizsgálat során jelentkező

nemkívánatos események ......................................122

5.2 Lehetséges nemkívánatos események ...........................122

Az eszközzel kapcsolatos nemkívánatos események bejelentése ...122

6 KLINIKAI VIZSGÁLATOK ÖSSZEFOGLALÁSA ........................122

6.1 Célpontok .......................................................122

6.2 Vizsgálati elrendezés ............................................122

6.2.1. táblázat. A betegek utánkövetése és

beszámoltathatósága ..........................................123

6.3 A betegek demográfiai adatai ...................................123

6.3.1. táblázat. Egyéni jellemzők összehasonlítása ...............123

6.3.2. táblázat. Az aneurysma-átmérők megoszlása ..............123

6.4 Eredmények ....................................................123

6.4.1. táblázat. Beültetett eszközök .............................124

6.4.2. táblázat. Elsődleges eredmények .........................124

6.4.3. táblázat. Sikermutatók ....................................125

6.4.4. táblázat. Abdominális röntgenfelvételek eredményei –

az eszköz épsége ..............................................125

6.4.5. táblázat. CT-felvételek eredményei – a graft

átjárhatósága ..................................................125

6.4.6. táblázat. CT-felvételek eredményei – graft

(fő graft-törzs) migrációja ......................................125

6.4.7. táblázat. Abdominális röntgenfelvételek eredményei –

ág leválása .....................................................126

6.5 Endoleak kezelése ...............................................126

6.5.1. táblázat. Endoleak-ek (valamennyi típus, új és perzisztens) 126

6.5.2. táblázat. Endoleak első előfordulása standard kockázatú

betegeknél ....................................................126

6.5.3. táblázat. Endoleak első előfordulása magas kockázatú

betegeknél ....................................................126

6.5.4. táblázat. Endoleak első előfordulása roll-in

betegeknél ....................................................126

6.6 Aneurysma változás .............................................127

6.6.1. táblázat. Az aneurysma maximális átmérőjében

bekövetkezett változások időintervallum szerint ................127

6.6.2. táblázat. Az aneurysma méretében és az endoleak-

státuszban bekövetkezett változások 12 hónapnál ..............127

6.6.3. táblázat. Az aneurysma méretében és az endoleak-

státuszban bekövetkezett változások 24 hónapnál ..............127

6.7 Az AAA-val összefüggő másodlagos beavatkozások ..............127

6.7.1. táblázat. Másodlagos beavatkozások (1-12. hónap) ........127

6.7.2. táblázat. Másodlagos beavatkozások

(>12-24. hónap) ................................................127

6.8 Másodlagos végpontok mérőszámai .............................128

6.8.1. táblázat. Másodlagos végpontok kezelési

csoportok szerint ..............................................128

7 A BETEGEK KIVÁLASZTÁSA ÉS KEZELÉSE ...........................128

A kezelés egyénivé tétele ...........................................128

8 BETEGTÁJÉKOZTATÁS .............................................128

9 KISZERELÉS ......................................................128

10 KLINIKAI FELHASZNÁLÁSSAL KAPCSOLATOS INFORMÁCIÓ ........128

10.1 Orvosképzés ...................................................128

10.2 Használat előtti szemle .........................................128

10.3 Szükséges anyagok ............................................128

10.4 Ajánlott anyagok ...............................................128

10.5 Az eszköz átmérője méretezésének irányelvei ...................129

10.5.1. táblázat. Útmutató a fő graft-törzs átmérőjének

méretezéséhez .................................................129

10.5.2. táblázat. Útmutató az iliaca-szár átmérőjének

méretezéséhez .................................................129

11 HASZNÁLATI UTASÍTÁS ..........................................129

Anatómiai követelmények ..........................................129

A felhasználással kapcsolatos általános információk .................129

Implantáció előtti meghatározó elemek .............................129

A beteg előkészítése ................................................129

11.1 Bifurcatiós rendszer ............................................129

11.1.1 A bifurcatiós fő grafttörzs előkészítése és öblítése ........129

11.1.2 A kontralaterális iliacaszár előkészítése és öblítése ........129

11.1.3 Az ipsilaterális iliacaszár előkészítése és öblítése ..........129

11.1.4 Vaszkuláris hozzáférés és angiográfia .....................129

11.1.5 A fő grafttörzs elhelyezése ...............................129

11.1.6 Kontralaterális iliaca vezetődrót elhelyezése ..............130

11.1.7 A fő grafttörzs proximális (csúcsi) telepítése ..............130

11.1.8 A kontralaterális iliacaszár elhelyezése és telepítése ......130

11.1.9 Fő grafttörzs disztális (alsó) telepítése ....................130

11.1.10 A csúcsi sapka összekapcsolása .........................130

11.1.11 Az ipsilaterális iliacaszár elhelyezése és telepítése .......130

11.1.12 A formázó ballon felvezetése ...........................130

Végső angiogram ......................................130

12 LEKÉPEZÉSI IRÁNYELVEK ÉS POSZTOPERATÍV UTÁNKÖVETÉS ......130

12.1 Általános ......................................................130

12.1. táblázat. Endografttal rendelkező betegek számára

ajánlott képalkotó vizsgálati program ..........................131

12.2 Kontrasztanyaggal és anélkül végzett CT-vizsgálattal

kapcsolatos ajánlások ..........................................131

12.2. táblázat. Elfogadható leképezési protokollok ..............131

12.3 Hasi röntgenfelvételek .........................................131

12.4 Ultrahang ......................................................131

12.5 MRI-kompatibilitás és -biztonságosság .........................131

12.6 További felügyelet és kezelés ...................................131

13 A BETEGEK NYOMONKÖVETÉSÉRE VONATKOZÓ INFORMÁCIÓ .....131

14 HIBAKERESÉS .......................................................131

14.1 Elsütődrótos kioldószerkezet hibakeresése .......................131

14.1.1 A fő grafttörzs proximális (csúcsi) telepítése .................. 131

14.1.2 A csúcsi sapka összekapcsolása .............................. 132

14.1.3 Az ipsilateralis iliacaszár elhelyezése és telepítése ............. 132

14.1.4 A kontralaterális iliacaszár elhelyezése és telepítése ........... 132

14.2 A suprarenalis sztent telepítésének hibakeresése .................132

14.2.1 A fő grafttörzs proximális (csúcsi) telepítése .................. 132

14.2.2 A csúcsi sapka összekapcsolása .............................. 132

14.2.3 Az ipsilateralis iliacaszár elhelyezése és telepítése .............132

14.2.4 A kontralaterális iliacaszár elhelyezése és telepítése ...........133

120

121

ITALIANO

INDICE

1 DESCRIZIONE DEL DISPOSITIVO .................................... 134

1.1 Corpo aortico principale e branche iliache della protesi ........... 134

1.2 Sistema di inserimento del corpo principale ...................... 134

1.3 Sistema di inserimento della branca iliaca ......................... 134

1.4 Componenti ausiliari dell’endoprotesi addominale Zenith .........134

2 INDICAZIONI PER L’USO ............................................134

3 CONTROINDICAZIONI .............................................. 134

4 AVVERTENZE E PRECAUZIONI ...................................... 134

4.1 Informazioni generali ............................................. 134

4.2 Selezione, trattamento e follow-up del paziente ..................

4.3 Tecniche di misurazione e imaging pre-procedura ................

4.4 Selezione del dispositivo ........................................135

4.5 Procedura di impianto ...........................................135

4.6 Uso del palloncino dilatatore ....................................135

4.7 Sicurezza e compatibilità in ambito MRI ...........................

5 EVENTI NEGATIVI .................................................. 135

5.1 Eventi negativi osservati ..........................................

Tabella 5.1.1 - Decesso e rottura nel corso dello studio clinico ....

Tabella 5.1.2 - Eventi negativi nel corso dello studio clinico .......136

5.2 Possibili eventi negativi ..........................................136

Notifica degli eventi negativi correlati al dispositivo .................136

6 RIEPILOGO DEGLI STUDI CLINICI ....................................136

6.1 Obiettivo ........................................................ 136

6.2 Struttura dello studio ............................................. 136

Tabella 6.2.1 - Follow-up dei pazienti e statistiche ................ 137

6.3 Caratteristiche demografiche dei pazienti ......................... 137

Tabella 6.3.1 - Confronto delle caratteristiche dei soggetti ........137

Tabella 6.3.2 - Distribuzione degli aneurismi in base al diametro. . 137

6.4 Risultati .......................................................... 137

Tabella 6.4.1 - Dispositivi impiantati ............................. 137

Tabella 6.4.2 - Risultati principali. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Tabella 6.4.3 - Parametri di valutazione del successo ............. 139

Tabella 6.4.4 - Eventi evidenziati mediante lastre radiografiche

addominali - Integrità del dispositivo ............................ 139

Tabella 6.4.5 - Eventi evidenziati mediante TC - Pervietà

dell’endoprotesi ................................................ 139

Tabella 6.4.6 - Eventi evidenziati mediante TC - Migrazione

dell’endoprotesi (corpo principale) .............................. 139

Tabella 6.4.7 - Eventi evidenziati mediante lastre radiografiche

addominali - Separazione delle estremità ........................ 140

6.5 Gestione degli endoleak .......................................... 140

Tabella 6.5.1 - Endoleak (tutti i tipi, nuovi e recidivi) ..............140

Tabella 6.5.2 - Prima occorrenza di endoleak per i pazienti a

rischio normale ................................................. 140

Tabella 6.5.3 - Prima occorrenza di endoleak per i pazienti ad

alto rischio. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Tabella 6.5.4 - Prima occorrenza di endoleak per i pazienti

di pratica ....................................................... 140

6.6 Mutazione dell’aneurisma ........................................ 141

Tabella 6.6.1 - Variazione del diametro massimo dell’aneurisma

per intervallo di tempo ......................................... 141

Tabella 6.6.2 - Variazione della dimensione dell’aneurisma e

endoleak a 12 mesi ............................................. 141

Tabella 6.6.3 - Variazione della dimensione dell’aneurisma e

endoleak a 24 mesi ............................................. 141

6.7 Interventi secondari correlati all’AAA ..............................141

Tabella 6.7.1 - Interventi secondari (da 0 a 12 mesi) .............. 141

Tabella 6.7.2 - Interventi secondari (da >12 a 24 mesi) ............ 141

6.8 Parametri per la valutazione degli esiti secondari .................. 142

Tabella 6.8.1 - Esiti secondari per gruppo di trattamento ......... 142

7 SELEZIONE E TRATTAMENTO DEI PAZIENTI ..........................142

Requisiti per il trattamento ........................................... 142

8 INFORMAZIONI DA FORNIRE AI PAZIENTI ........................... 142

9 CONFEZIONAMENTO ..............................................142

10 INFORMAZIONI PER USO CLINICO ................................. 142

10.1 Programma di formazione per il medico ......................... 142

10.2 Esame prima dell’uso ........................................... 142

10.3 Materiali necessari .............................................. 142

10.4 Materiali consigliati ............................................. 142

10.5 Linee guida per la determinazione del diametro idoneo

del dispositivo ....................................................... 143

Tabella 10.5.1 - Guida alla determinazione del diametro idoneo

del corpo principale dell’endoprotesi ............................143

Tabella 10.5.2 - Guida alla determinazione del diametro idoneo

della branca iliaca dell’endoprotesi ..............................143

11 ISTRUZIONI PER L’USO ............................................143

Requisiti anatomici .................................................. 143

Informazioni generali sull’impiego ................................... 143

Fattori da considerare in sede preliminare ............................143

Preparazione del paziente ...........................................143

11.1 Sistema biforcato ............................................... 143

11.1.1 Preparazione/lavaggio del corpo principale biforcato ......143

11.1.2 Preparazione/lavaggio della branca iliaca controlaterale ...143

11.1.3 Preparazione/lavaggio della branca iliaca ipsilaterale ...... 143

11.1.4 Accesso al sistema vascolare e angiografia ................ 143

11.1.5 Posizionamento del corpo principale .....................143

11.1.6 Posizionamento della guida iliaca controlaterale .......... 144

11.1.7 Rilascio dell’estremità prossimale (superiore) del corpo

principale ...................................................... 144

11.1.8 Posizionamento e rilascio della branca iliaca controlaterale 144

11.1.9 Rilascio dell’estremità distale (inferiore) del corpo

principale ...................................................... 144

11.1.10 Innesto della calotta superiore ........................... 144

11.1.11 Posizionamento e rilascio della branca iliaca ipsilaterale .. 144

11.1.12 Inserimento del palloncino dilatatore .................... 144

Angiogramma conclusivo ................................ 145

12 LINEE GUIDA PER LE TECNICHE DI IMAGING E IL FOLLOW-UP

POSTOPERATORIO ................................................145

12.1 Generali ........................................................ 145

Tabella 12.1 - Programma consigliato per le procedure di

imaging per i pazienti portatori di endoprotesi .................. 145

12.2 Consigli per la TC con e senza mezzo di contrasto ................ 145

Tabella 12.2 Protocolli di imaging accettabili ..................... 145

12.3 Lastre radiografiche addominali ................................. 145

12.4 Ecografia .......................................................145

12.5 Sicurezza e compatibilità in ambito MRI ......................... 145

12.6 Ulteriori esami di controllo e trattamento ........................ 146

13 INFORMAZIONI DOCUMENTANTI IL DISPOSITIVO .................. 146

14 GUIDA ALLA RISOLUZIONE DEI PROBLEMI ...........................146

14.1 Risoluzione dei problemi relativi al meccanismo di rilascio a filo di

sicurezza ...............................................................146

14.1.1 Rilascio dell’estremità prossimale (superiore) del corpo

principale ..............................................................146

14.1.2 Innesto della calotta superiore ..................................146

14.1.3 Posizionamento e rilascio della branca iliaca ipsilaterale ........146

14.1.4 Posizionamento e rilascio della branca iliaca controlaterale .....146

14.2 Risoluzione dei problemi relativi al rilascio dello stent soprarenale. . 146

14.2.1 Rilascio dell’estremità prossimale (superiore) del corpo

principale ..............................................................146

14.2.2 Innesto della calotta superiore ..................................147

14.2.3 Posizionamento e rilascio della branca iliaca ipsilaterale ........147

14.2.4 Posizionamento e rilascio della branca iliaca controlaterale .....147

134 134

135

135 135

NEDERLANDS

INHOUD

1 BESCHRIJVING VAN HET HULPMIDDEL ..............................148

1.1 Componenten voor main body in de aorta en voor iliacale poten .. 148

1.2 Introductiesysteem van de main body ............................ 148

1.3 Introductiesysteem van de iliacale poot ........................... 148

1.4 Zenith hulpcomponenten voor de AAA endovasculaire prothese .. 148

2 INDICATIES VOOR GEBRUIK .......................................148

3 CONTRA-INDICATIES ...............................................148

4 WAARSCHUWINGEN EN VOORZORGSMAATREGELEN ................ 148

4.1 Algemeen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

4.2 Selectie, behandeling en controle van de patiënt ................

4.3 Preprocedurele meettechnieken en beeldvorming ...............

4.4 Selectie van het hulpmiddel .....................................149

4.5 De implantatieprocedure ........................................149

4.6 Gebruik van de modelleerballon .................................149

4.7 MRI-veiligheid en -compatibiliteit .................................

5 ONGEWENSTE VOORVALLEN ....................................... 149

5.1 Waargenomen ongewenste voorvallen ...........................

Tabel 5.1.1 Overlijden en ruptuur bij klinische studie .............

Tabel 5.1.2 Ongewenste voorvallen in klinische studie ........... 150

5.2 Mogelijke ongewenste voorvallen ................................ 150

Melding van prothesegerelateerde ongewenste voorvallen ..........150

6 SAMENVAT TING VAN KLINISCHE STUDIES ........................... 150

6.1 Doelstellingen ...................................................150

6.2 Opzet van de studie .............................................. 150

Tabel 6.2.1 Patiëntcontrole en controleerbaarheid ............... 151

6.3 Demografische patiëntgegevens ................................. 151

Tabel 6.3.1 Vergelijking van kenmerken van proefpersonen ...... 151

Tabel 6.3.2 Verdeling diameter aneurysma ....................... 151

6.4 Resultaten ....................................................... 151

Tabel 6.4.1 Gebruikte implantaten ...............................152

Tabel 6.4.2 Primaire resultaten ...................................152

Tabel 6.4.3 Resultaatmetingen .................................. 153

Tabel 6.4.4 Abdominale radiografische bevindingen –

Integriteit van de prothese ...................................... 153

Tabel 6.4.5 CT-bevindingen – Afwezigheid van obstructies

in prothese ..................................................... 153

Tabel 6.4.6 CT-bevindingen – Migratie van main body ........... 153

Tabel 6.4.7 Abdominale radiografische bevindingen –

losraken van de stompen ....................................... 154

6.5 Behandeling van endolekkages ................................... 154

Tabel 6.5.1 Endolekkages (alle typen, nieuw en persistent) ....... 154

Tabel 6.5.2 Eerste voorkomen van endolekkage bij patiënten

met standaardrisico ............................................. 154

Tabel 6.5.3 Eerste voorkomen van endolekkage bij patiënten

met hoog risico ................................................. 154

Tabel 6.5.4 Eerste voorkomen van endolekkage bij

oefenpatiënten ................................................. 154

6.6 Veranderingen van het aneurysma. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Tabel 6.6.1 Verandering van de maximale diameter van het

aneurysma per interval ......................................... 155

Tabel 6.6.2 Veranderingen in afmeting van het aneur ysma en de

endolekkage na 12 maanden ................................... 155

Tabel 6.6.3 Veranderingen in afmeting van het aneur ysma en de

endolekkage na 24 maanden ................................... 155

6.7 AAA-gerelateerde secundaire interventies ........................ 155

Tabel 6.7.1 Secundaire interventies (tot 12 maanden) ............ 155

Tabel 6.7.2 Secundaire interventies (> 12 tot 24 maanden) ....... 155

6.8 Metingen secundaire resultaten .................................. 156

Tabel 6.8.1 Secundaire resultaten per behandelgroep ............156

7 SELECTIE EN BEHANDELING VAN DE PATIËNT .......................156

Individualisering van de behandeling ................................ 156

8 DE PATIËNT INFORMEREN .......................................... 156

9 WIJZE VAN LEVERING .............................................. 156

10 INFORMATIE OVER HET KLINISCHE GEBRUIK .......................156

10.1 Opleiding van de arts ........................................... 156

10.2 Inspectie voorafgaand aan gebruik .............................. 156

10.3 Benodigde materialen ..........................................156

10.4 Aanbevolen materialen ......................................... 156

10.5 Richtlijnen voor het bepalen van de diameter van

het hulpmiddel ...................................................... 157

Tabel 10.5.1 Handleiding voor het bepalen van de diameter

van de main body ............................................... 157

Tabel 10.5.2 Handleiding voor het bepalen van de diameter

van de iliacale poot ............................................. 157

11 GEBRUIKSAANWIJZING ........................................... 157

Anatomische vereisten ............................................... 157

Algemene gebruiksinformatie ........................................ 157

Bepalende factoren vóór de implantatie .............................. 157

De patiënt voorbereiden ............................................. 157

11.1 Bifurcatiesysteem ............................................... 157

11.1.1 Voorbereiding/spoelen van de main body met bifurcatie ..157

11.1.2 Voorbereiding/spoelen van de contralaterale iliacale poot ..157

11.1.3 Voorbereiding/spoelen van de ipsilaterale iliacale poot ....157

11.1.4 Vasculaire introductie en angiografie. . . . . . . . . . . . . . . . . . . . . . 157

11.1.5 Plaatsing van de main body ..............................157

11.1.6 De contralaterale iliacale voerdraad plaatsen .............. 158

11.1.7 Ontplooiing van het proximale deel (top) van de main

body ........................................................... 158

11.1.8 Plaatsing en ontplooiing van de contralaterale iliacale

poot ............................................................ 158

11.1.9 Ontplooiing van het distale deel (onderkant) main body ..158

11.1.10 Koppelen van de topkap ................................ 158

11.1.11 Plaatsing en ontplooiing van de ipsilaterale iliacale poot . 158

11.1.12 Introductie van de modelleerballon ..................... 158

Afrondend angiogram ................................... 158

12 RICHTLIJNEN VOOR BEELDVORMEND ONDERZOEK EN

POSTOPERATIEVE CONTROLE ..................................... 159

12.1 Algemeen ...................................................... 159

Tabel 12.1 Aanbevolen schema voor beeldvorming bij patiënten

met een endovasculaire prothese ............................... 159

12.2 Aanbevelingen voor CT-onderzoek met en zonder

contrastmiddel .................................................159

Tabel 12.2 Geaccepteerde beeldvormingsprotocollen ............ 159

12.3 Röntgenopnamen van de buik .................................. 159

12.4 Echografie ...................................................... 159

12.5 Veiligheid bij en compatibiliteit met MRI .........................159

12.6 Extra controle en behandeling ..................................159

13 INFORMATIE PATIËNTVOLGSYSTEEM ..............................159

14 OPLOSSEN VAN PROBLEMEN ........................................160

14.1 Problemen met de ontkoppeling van de trigger wire oplossen .....160

14.1.1 Ontplooiing van het proximale deel (top) van de main body . 160

14.1.2 Koppelen van de topkap .....................................160

14.1.3 Plaatsing en ontplooiing van de ipsilaterale iliacale poot .....160

14.1.4 Plaatsing en ontplooiing van de contralaterale iliacale poot ..160

14.2 Problemen met de ontplooiing van de suprarenale stent oplossen . 160

14.2.1 Ontplooiing van het proximale deel (top) van de main body . 160

14.2.2 Koppelen van de topkap .....................................160

14.2.3 Plaatsing en ontplooiing van de ipsilaterale iliacale poot .....160

14.2.4 Plaatsing en ontplooiing van de contralaterale iliacale poot ..161

148 148

149

149 149

NORSK

INNHOLDSFORTEGNELSE

1 BESKRIVELSE AV ANORDNINGEN ...................................162

1.1 Aortisk hoveddel og iliaca-benkomponenter .....................162

1.2 Hoveddelens innføringssystem ...................................162

1.3 Iliaca-ben innføringssystem ......................................162

1.4 Hjelpekomponenter for Zenith AAA endovaskulært implantat ....162

2 BRUKSOMRÅDER ..................................................162

3 KONTRAINDIKASJONER ............................................162

4 ADVARSLER OG FORHOLDSREGLER ................................162

4.1 Generelt .........................................................

4.2 Pasientutvelgelse, behandling og oppfølging ....................162

4.3 Målingsteknikker og avbilding før prosedyren. . . . . . . . . . . . . . . . . . . . 162

4.4 Valg av anordning ...............................................163

4.5 Implantasjon ....................................................163

4.6 Bruk av formingsballong ........................................163

4.7 MR-sikkerhet og kompatibilitet ...................................

5 UGUNSTIGE HENDELSER ...........................................163

5.1 Observerte ugunstige hendelser .................................163

Tabell 5.1.1 Død og ruptur fra klinisk studie ........................163

Tabell 5.1.2 Ugunstige hendelser i klinisk studie ....................164

5.2 Mulige ugunstige hendelser ......................................164

Rapportering av ugunstige hendelser, relatert til anordningen .....164

6 OVERSIKT AV KLINISKE STUDIER ...................................164

6.1 Målsetninger .....................................................164

6.2 Studiedesign .....................................................164

Tabell 6.2.1 Pasientoppfølging og ansvarlighet ..................... 165

6.3 Pasientbefolkningsstatistikk ..................................... 165

Tabell 6.3.1 Sammenligning av forsøkspersoners karakteristika .....165

Tabell 6.3.2 Distribusjon av aneurismens diameter ................. 165

6.4 Resultater ........................................................165

Tabell 6.4.1 Implanterte anordninger ..............................165

Tabell 6.4.2 Primære resultater .....................................166

Tabell 6.4.3 Suksessmål ............................................167

Tabell 6.4.4 Funn under abdominal røntgen –

anordningens integritet ........................................... 167

Tabell 6.4.5 CT-funn – implantatpatens .............................167

Tabell 6.4.6 CT-funn – implantat (hoveddel)-vandring .............. 167

Tabell 6.4.7 Funn under abdominal røntgen – løsning av lem ....... 168

6.5 Behandling av endolekkasje ......................................168

Tabell 6.5.1 Endolekkasjer (alle typer, nye og persistente) ...........168

Tabell 6.5.2 Første tilfelle av endolekkasje for

standardrisikopasienter ............................................168

Tabell 6.5.3 Første tilfelle av endolekkasje for høyrisikopasienter .... 168

Tabell 6.5.4 Første tilfelle av endolekkasje for innlæringspasienter .. 168

6.6 Aneurismeendringer .............................................169

Tabell 6.6.1 Aneurismens maksimale diameterendring pr. intervall ..169 Tabell 6.6.2 Endring i aneurismens størrelse og endolekkasje ved

12 måneder .......................................................169

Tabell 6.6.3 Endring i aneurismens størrelse og endolekkasje ved

24 måneder .......................................................169

6.7 AAA-relaterte sekundære intervensjoner .........................169

Tabell 6.7.1 Sekundære intervensjoner (til 12 måneder) ............ 169

Tabell 6.7.2 Sekundære intervensjoner (>12 til 24 måneder) ........169

6.8 Måltall for sekundære resultater ..................................170

Tabell 6.8.1 Sekundære resultater pr. behandlingsgruppe ..........170

7 PASIENTUTVALG OG BEHANDLING .................................170

Individualisering av behandlingen ...................................170

8 PASIENTRÅDFØRINGSINFORMASJON ...............................170

162

163

9 LEVERING .........................................................170

10 INFORMASJON OM KLINISK ANVENDELSE .......................170

10.1 Legeopplæring .................................................170

10.2 Inspeksjon før bruk .............................................170

10.3 Nødvendige materialer .........................................170

10.4 Anbefalte materialer ............................................170

10.5 Retningslinjer for størrelsesmåling av anordningens diameter ...170

Tabell 10.5.1 Diameterstørrelsesguide for hoveddel-implantat ...... 171

Tabell 10.5.2 Diameterstørrelsesguide for iliaca-ben implantat ......171

11 BRUKSVEILEDNING ...............................................171

Anatomiske krav .....................................................171

Allmenn bruksinformasjon ...........................................171

Avgjørende faktorer før implantasjonen ..............................171

Klargjøring av pasienten .............................................171

11.1 Bifurkert system ................................................171

11.1.1 Forberedelse/skylling av bifurkert hoveddel .................171

11.1.2 Forberedelse/skylling av kontralateral iliaca-ben .............171

11.1.3 Forberedelse/skylling av ipsilateralt iliaca-ben ...............171

11.1.4 Vaskulær tilgang og angiografi ..............................171

11.1.5 Plassering av hoveddel ......................................171

11.1.6 Plassering av kontralateral iliaca-ledevaier ...................171

11.1.7 Proksimal (topp) anleggelse av hoveddel ....................171

11.1.8 Plassering og anleggelse av

11.1.9 Distal (bunn) anleggelse av hoveddel ....................... 172

11.1.10 Sammenkobling av topphetten ............................172

11.1.11 Plassering og anleggelse av ipsilateralt iliaca-ben ..........172

11.1.12 Innføring av formingsballong ..............................172

Sluttangiogram ........................................... 172

12 RETNINGSLINJER FOR AVBILDING OG POSTOPERATIV

OPPFØLGING .................................................... 172

12.1 Generelt ........................................................172

Tabell 12.1 Anbefalt avbildingsprogram for pasienter

med endoimplantat ...............................................173

12.2 Anbefalinger for CT med og uten kontrast .......................173

Tabell 12.2 Godkjente avbildingsprotokoller ....................... 173

12.3 Abdominale røntgenbilder ......................................173

12.4 Ultralyd .........................................................173

12.5 MRI-sikkerhet og kompatibilitet .................................173

12.6 Ytterligere kontroll og behandling .............................. 173

13 SPORING AV PASIENTINFORMASJON ..............................173

14 FEILSØKING .........................................................173

14.1 Feilsøking for vaierutløsningsmekanisme ..........................

14.1.1 Proksimal (topp) anleggelse av hoveddel ....................173

14.1.2 Sammenkobling av topphetten ..............................

14.1.3 Plassering og anleggelse av ipsilateralt iliaca-ben ............

14.1.4 Plassering og anleggelse av kontralateralt iliaca-ben .........

14.2 Feilsøking for anleggelse av suprarenal stent .......................

14.2.1 Proksimal (topp) anleggelse av hoveddel ....................

14.2.2 Sammenkobling av topphetten ..............................

14.2.3 Plassering og anleggelse av ipsilateralt iliaca-ben ............

14.2.4 Plassering og anleggelse av kontralateralt iliaca-ben .........

kontralateralt

iliaca-ben. . . . . . . . . 172

173

173 174 174 174 174 174 174 174

POLSKI

SPIS TREŚCI

1 OPIS URZĄDZENIA ................................................175

1.1 Główny trzon aortalny i odnogi biodrowe ........................175

1.2 System podawania głównego trzonu ............................175

1.3 System podawania odnogi biodrowej ............................175

1.4 Elementy pomocnicze do stent-graftu wewnątrznaczyniowego

Zenith AAA .........................................................175

2 WSKAZANIA DO STOSOWANIA ....................................175

3 PRZECIWWSKAZANIA .............................................175

4 OSTRZEŻENIA I ŚRODKI OSTROŻNOŚCI ............................175

4.1 Ogólne ..........................................................

4.2 Wybór pacjentów, leczenie i kontrola po zabiegu .................175

4.3 Techniki pomiarów przedoperacyjnych i obrazowanie ............175

4.4 Wybór urządzenia ...............................................176

4.5 Procedura wszczepiania .........................................176

4.6 Użycie balonu kształtującego ....................................176

4.7 Bezpieczeństwo i zgodność z badaniem MRI ......................

5 ZDARZENIA NIEPOŻĄDANE .......................................176

5.1 Obserwowane zdarzenia niepożądane ...........................176

Tabela 5.1.1 Zgon i pęknięcie – dane z badania klinicznego .....176

Tabela 5.1.2 Zdarzenia niepożądane w badaniu klinicznym ......177

5.2 Potencjalne zdarzenia niepożądane .............................177

Zgłaszanie zdarzeń niepożądanych związanych z urządzeniem ..177

6 STRESZCZENIE BADAŃ KLINICZNYCH ..............................177

6.1 Cele .............................................................177

6.2 Schemat badania ................................................177

Tabela 6.2.1 Kontrola i ewidencja pacjentów ....................178

6.3 Dane demograficzne pacjentów .................................178

Tabela 6.3.1 Porównanie charakterystyki pacjentów .............178

Tabela 6.3.2 Rozkład średnic tętniaków .........................178

6.4 Wyniki ..........................................................178

Tabela 6.4.1 Wszczepione urządzenia ...........................179

Tabela 6.4.2 Wyniki pierwszorzędowe ...........................179

Tabela 6.4.3 Wyniki oceny skuteczności .........................180

Tabela 6.4.4 Wyniki badania radiologicznego jamy brzusznej –

integralność urządzenia ........................................180

Tabela 6.4.5 Wyniki badania TK – drożność stent-graftu .........180

Tabela 6.4.6 Wyniki badania TK – przemieszczenie stent-graftu

(głównego trzonu) .............................................180

Tabela 6.4.7 Wyniki badania rtg jamy brzusznej –

oddzielenie odgałęzienia .......................................181

6.5 Postępowanie w razie przecieku wewnętrznego. . . . . . . . . . . . . . . . . . 181

Tabela 6.5.1 Przecieki wewnętrzne (wszystkie typy, nowe

i przetrwałe) ...................................................181

Tabela 6.5.2 Pierwszorazowe wystąpienie przecieku

wewnętrznego u pacjentów ze standardowym ryzykiem ........181

Tabela 6.5.3 Pierwszorazowe wystąpienie przecieku

wewnętrznego u pacjentów z wysokim ryzykiem ...............181

Tabela 6.5.4 Pierwszorazowe wystąpienie przecieku

wewnętrznego u pacjentów z grupy próbnej ...................181

6.6 Zmiana w obrębie tętniaka ......................................182

Tabela 6.6.1 Zmiana maksymalnej średnicy tętniaka

w poszczególnych okresach badania ...........................182

Tabela 6.6.2 Zmiana średnicy tętniaka i przeciek wewnętrzny

w okresie 12 miesięcy ..........................................182

Tabela 6.6.3 Zmiana średnicy tętniaka i przeciek wewnętrzny

w okresie 24 miesięcy ..........................................182

6.7 Interwencje wtórne związane z AAA .............................182

Tabela 6.7.1 Interwencje wtórne (do 12 miesięcy) ...............182

Tabela 6.7.2 Interwencje wtórne (>12 do 24 miesięcy) ...........182

6.8 Wskaźniki wyników drugorzędowych ............................183

Tabela 6.8.1 Wyniki drugorzędowe w poszczególnych

grupach leczenia ...............................................183

7 DOBÓR I LECZENIE PACJENTÓW ...................................183

Indywidualizacja leczenia ...........................................183

8 INFORMACJE DLA PACJENTA ......................................183

9 RODZAJ OPAKOWANIA ...........................................183

10 INFORMACJE DOTYCZĄCE ZASTOSOWANIA KLINICZNEGO .........183

10.1 Szkolenie lekarza ...............................................183

10.2 Kontrola przed użyciem ........................................183

10.3 Wymagane materiały ...........................................183

10.4 Materiały zalecane .............................................183

10.5 Wskazówki dotyczące kalibrowania średnicy przyrządu .........184

Tabela 10.5.1 Wskazówki dotyczące kalibrowania średnicy

głównego trzonu stent-graftu ..................................184

Tabela 10.5.2 Wskazówki dotyczące kalibrowania średnicy

odnogi biodrowej stent-graftu .................................184

11 WSKAZANIA ....................................................184

Wymagania anatomiczne ............................................

Ogólne informacje o stosowaniu .....................................

Przedimplantacyjne czynniki determinujące ..........................

Przygotowanie pacjenta .............................................

11.1 System rozwidlony .............................................184

11.1.1 Przygotowanie/przepłukiwanie rozwidlonego trzonu

głównego .....................................................184

11.1.2 Przygotowanie/przepłukiwanie przeciwstronnej odnogi

biodrowej .....................................................184

11.1.3 Przygotowanie/przepłukiwanie tożsamostronnej odnogi

biodrowej .....................................................184

11.1.4 Dostęp naczyniowy i angiografia .........................184

11.1.5 Umieszczanie głównego trzonu ..........................184

11.1.6 Umieszczanie przeciwstronnego prowadnika

biodrowego ...................................................185

11.1.7 Rozprężanie proksymalnej (górnej) części głównego

trzonu .........................................................185

11.1.8 Umieszczanie i rozprężanie przeciwstronnej odnogi

biodrowej .....................................................185

11.1.9 Rozprężanie dystalnej (dolnej) części głównego trzonu ...185

11.1.10 Łączenie nasadki końcówki .............................185

11.1.11 Umieszczanie i rozprężanie tożsamostronnej odnogi

biodrowej .....................................................185

11.1.12 Wprowadzenie balonu kształtującego ...................185

Angiogram końcowy ...................................186

12 WSKAZÓWKI DOTYCZĄCE OBRAZOWANIA I KONTROLA PO ZABIEGU ..186

12.1 Ogólne ........................................................186

Tabela 12.1 Zalecany harmonogram badań dla pacjentów

ze stent-graftami wewnątrznaczyniowymi ......................186

12.2 Zalecenia dotyczące badania TK z kontrastem i bez kontrastu ...186

Tabela 12.2 Dopuszczalne protokoły obrazowania ..............186

12.3 Radiogramy brzuszne ..........................................186

12.4 Badanie USG ...................................................186

12.5 Bezpieczeństwo i zgodność z badaniem MRI ....................186

12.6 Dodatkowy nadzór i leczenie ...................................187

13 INFORMACJE DOTYCZĄCE OBSERWACJI PACJENTÓW ..............187

14 ROZWIĄZYWANIE PROBLEMÓW .....................................187

14.1 Rozwiązywanie problemów dotyczących uwalniania drutu

zwalniającego ..........................................................187

14.1.1 Rozprężanie proksymalnej (górnej) części głównego trzonu

14.1.2 Łączenie nasadki końcówki

14.1.3 Umieszczanie i rozprężanie tożsamostronnej odnogi biodrowej

14.1.4 Umieszczanie i rozprężanie przeciwstronnej odnogi biodrowej

14.2 Rozwiązywanie problemów dotyczących rozprężania stentu

nadnerkowego .........................................................187

14.2.1 Rozprężanie proksymalnej (górnej) części głównego trzonu

14.2.2 Łączenie nasadki końcówki

14.2.3 Umieszczanie i rozprężanie tożsamostronnej odnogi biodrowej

14.2.4 Umieszczanie i rozprężanie przeciwstronnej odnogi biodrowej

..................................187

..................................188

175

176

184 184 184 184

...187

. 187

..187

...187

. 188

..188

PORTUGUÊS

ÍNDICE

1 DESCRIÇÃO DO DISPOSITIVO ....................................... 189

1.1 Componentes do corpo aórtico principal e extremidades ilíacas ... 189

1.2 Sistema de colocação do corpo principal ......................... 189

1.3 Sistema de colocação da extremidade ilíaca ...................... 189

1.4 Componentes auxiliares da prótese endovascular AAA Zenith ..... 189

2 INDICAÇÕES DE UTILIZAÇÃO .......................................189

3 CONTRA-INDICAÇÕES ..............................................189

4 ADVERTÊNCIAS E PRECAUÇÕES .................................... 189

4.1 Geral ............................................................ 189

4.2 Selecção, tratamento e seguimento dos doentes .................

4.3 Técnicas de medição e imagiologia antes do procedimento ......

4.4 Escolha do dispositivo ...........................................190

4.5 Procedimento de implantação ...................................190

4.6 Utilização do balão de moldagem ...............................190

4.7 Segurança e compatibilidade com RMN ..........................

5 EFEITOS ADVERSOS ................................................190

5.1 Efeitos adversos observados ......................................

Tabela 5.1.1 Morte e rotura ocorridas no estudo clínico ..........

Tabela 5.1.2 Efeitos adversos no estudo clínico ...................191

5.2 Efeitos adversos potenciais ....................................... 191

Relato de efeitos adversos relacionados com o dispositivo ...........191

6 SÍNTESE DOS ESTUDOS CLÍNICOS ..................................191

6.1 Objectivos ....................................................... 191

6.2 Desenho do estudo .............................................. 191

Tabela 6.2.1 Seguimento e responsabilidade dos doentes ........192

6.3 Dados demográficos dos doentes ................................192

Tabela 6.3.1 Comparação das características dos sujeitos .........192

Tabela 6.3.2 Distribuição dos diâmetros dos aneurismas ......... 192

6.4 Resultados ....................................................... 192

Tabela 6.4.1 Dispositivos implantados ........................... 192

Tabela 6.4.2 Resultados primários ............................... 193

Tabela 6.4.3 Avaliações do sucesso .............................. 194

Tabela 6.4.4 Achados radiográficos abdominais - integridade

do dispositivo ..................................................194

Tabela 6.4.5 Achados da TAC - permeabilidade da prótese. . . . . . . . 194

Tabela 6.4.6 Achados da TAC - migração da prótese

(corpo principal) ................................................ 194

Tabela 6.4.7 Achados radiográficos abdominais -

separação dos ramos ........................................... 195

6.5 Tratamento de fugas intra-aneurismais ........................... 195

Tabela 6.5.1 Fugas intra-aneurismais (todos os tipos, novas

e persistentes) .................................................. 195

Tabela 6.5.2 Primeira ocorrência de fugas intra-aneurismais

para doentes de risco normal ................................... 195

Tabela 6.5.3 Primeira ocorrência de fugas intra-aneurismais

para doentes de alto risco ....................................... 195

Tabela 6.5.4 Primeira ocorrência de fugas intra-aneurismais

para doentes não permanentes ................................. 195

6.6 Alterações do aneurisma ......................................... 196

Tabela 6.6.1 Alterações nos diâmetros máximos dos

aneurismas por intervalo ........................................ 196

Tabela 6.6.2 Alterações no tamanho do aneurisma e fugas

intra-aneurismais aos 12 meses .................................196

Tabela 6.6.3 Alterações no tamanho do aneurisma e fugas

intra-aneurismais aos 24 meses .................................196

6.7 Intervenções secundárias relacionadas com AAA .................. 196

Tabela 6.7.1 Intervenções secundárias (aos 12 meses) ............ 196

Tabela 6.7.2 Intervenções secundárias (> 12 aos 24 meses) ....... 196

6.8 Avaliações dos resultados secundários ............................ 197

Tabela 6.8.1 Resultados secundários por grupo de tratamento ... 197

7 SELECÇÃO E TRATAMENTO DE DOENTES ............................197

Individualização do tratamento ...................................... 197

8 INFORMAÇÃO DE ACONSELHAMENTO AOS DOENTES ...............197

189 189

190

190 190

9 APRESENTAÇÃO ...................................................197

10 INFORMAÇÃO PARA UTILIZAÇÃO CLÍNICA ......................... 197

10.1 Formação de médicos ........................................... 197

10.2 Inspecção antes da utilização. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

10.3 Materiais necessários ............................................ 197

10.4 Materiais recomendados ........................................ 197

10.5 Orientações para escolha do diâmetro do dispositivo ............ 198

Tabela 10.5.1 Guia para escolha do diâmetro do corpo principal

da prótese ...................................................... 198

Tabela 10.5.2 Guia para escolha do diâmetro da extremidade

ilíaca da prótese ................................................ 198

11 INSTRUÇÕES DE UTILIZAÇÃO .....................................198

Requisitos anatómicos ............................................... 198

Informação geral sobre a utilização .................................. 198

Factores determinantes antes da implantação ........................ 198

Preparação do doente ............................................... 198

11.1 Sistema bifurcado ............................................... 198

11.1.1 Preparação/irrigação do corpo principal bifurcado ........ 198

11.1.2 Preparação/irrigação da extremidade ilíaca contralateral .. 198

11.1.3 Preparação/irrigação da extremidade ilíaca

11.1.4 Acesso vascular e angiografia ............................. 198

11.1.5 Colocação do corpo principal ............................. 198

11.1.6 Colocação do fio guia ilíaco contralateral .................. 199

11.1.7 Expansão da parte proximal (topo) do corpo principal ..... 199

11.1.8 Colocação e expansão da extremidade ilíaca contralateral ...199

11.1.9 Expansão da parte distal (inferior) do corpo principal ...... 199

11.1.10 Acoplagem da tampa superior. . . . . . . . . . . . . . . . . . . . . . . . . . . 199

11.1.11 Colocação e expansão da extremidade ilíaca ipsilateral .....

11.1.12 Inserção do balão de moldagem ......................... 199

Angiograma final ........................................ 199

12 ORIENTAÇÕES RELATIVAS À IMAGIOLOGIA E AO SEGUIMENTO

PÓS-OPERATÓRIO ................................................200

12.1 Geral ...........................................................200

Tabela 12.1 Plano de exames imagiológicos recomendado para

doentes com próteses endovasculares .......................... 200

12.2 Recomendações para TAC com e sem contraste .................. 200

Tabela 12.2 Protocolos de imagiologia aceitáveis ................200

12.3 Radiografias abdominais ........................................ 200

12.4 Ecografia .......................................................200

12.5 Segurança e compatibilidade com RMN ......................... 200

12.6 Vigilância e tratamento adicionais ...............................200

13 INFORMAÇÃO SOBRE A LOCALIZAÇÃO DE DOENTES ............... 200

14 RESOLUÇÃO DE PROBLEMAS ........................................200

14.1 Resoluções de problemas relativos ao mecanismo de libertação

com fio de comando ................................................... 201

14.1.1 Expansão da parte proximal (topo) do corpo principal. . . . . . . . . . 201

14.1.2 Acoplagem da tampa superior ..................................201

14.1.3 Colocação e expansão da extremidade ilíaca ipsilateral .........201

14.1.4 Colocação e expansão da extremidade ilíaca contralateral. . . . . . 201

14.2 Resolução de problemas relativos à expansão do stent supra-renal . 201

14.2.1 Expansão da parte proximal (topo) do corpo principal. . . . . . . . . . 201

14.2.2 Acoplagem da tampa superior ..................................201

14.2.3 Colocação e expansão da extremidade ilíaca ipsilateral .........201

14.2.4 Colocação e expansão da extremidade ilíaca contralateral. . . . . . 202

ipsilateral

. . . . . . 198

199

SVENSKA

INNEHÅLLSFÖRTECKNING

1 PRODUKTBESKRIVNING ............................................ 203

1.1 Aortahuvudstomme och komponenter för iliakaliskt graftben ..... 203

1.2 Införingssystem för huvudstommen .............................. 203

1.3 Det iliakaliska graftbenets införingssystem ........................ 203

1.4 Kompletterande komponenter för Zenith AAA endovaskulära

transplantat ......................................................... 203

2 AVSEDD ANVÄNDNING ............................................203

3 KONTRAINDIKATIONER ............................................ 203

4 VARNINGAR OCH FÖRSIKTIGHETSÅTGÄRDER ........................ 203

4.1 Allmänt .......................................................... 203

4.2 Patienturval, behandling och uppföljning ........................

4.3 Mättekniker och bildtagning före proceduren ....................

4.4 Val av anordning ................................................204

4.5 Implantationsförfarande .........................................204

4.6 Användning av formningsballong ...............................204

4.7 MRT-säkerhet och -kompabilitet ..................................

5 BIVERKNINGAR .................................................... 204

5.1 Observerade biverkningar ........................................

Tabell 5.1.1 Dödsfall och ruptur från den kliniska studien. . . . . . . . .

Tabell 5.1.2 Biverkningar i klinisk studie .......................... 205

5.2 Eventuella biverkningar .......................................... 205

Rapportering av biverkningar som har samband med anordningen ..205

6 SAMMANFATTNING AV KLINISKA STUDIER .......................... 205

6.1 Syfte ............................................................. 205

6.2 Studiedesign ..................................................... 205

Tabell 6.2.1 Patientuppföljning och redovisning ................. 206

6.3 Demografiska uppgifter om patienterna .......................... 206

Tabell 6.3.1 Jämförelse av patientkarakteristika .................. 206

Tabell 6.3.2 Distribution av aneurysmdiameter ................... 206

6.4 Resultat .......................................................... 206

Tabell 6.4.1 Implanterade anordningar .......................... 206

Tabell 6.4.2 Primära resultat ..................................... 207

Tabell 6.4.3 Mått på framgång ................................... 208

Tabell 6.4.4 Fynd vid radiografi av buken – anordningens

integritet ....................................................... 208

Tabell 6.4.5 DT-fynd – transplantatets öppenhet ................. 208

Tabell 6.4.6 DT-fynd – migration av transplantatet (huvudstommen) 208

Tabell 6.4.7 Fynd vid radiografi av buken – separation av lem ....209

6.5 Hantering av endoläckage ........................................ 209

Tabell 6.5.1 Endoläckage (alla typer, nya och ihållande) ..........209

Tabell 6.5.2 Första förekomst av endoläckage för standardrisk

patienter ....................................................... 209

Tabell 6.5.3 Första förekomst av endoläckage för högrisk patienter 209 Tabell 6.5.4 Första förekomst av endoläckage för prekliniska

patienter ....................................................... 209

6.6 Förändring av aneurysm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

Tabell 6.6.1 Förändring av maximal aneurysmdiameter per

intervall ........................................................210

Tabell 6.6.2 Förändring av aneurysmstorlek och endoläckage

vid 12 månader ................................................. 210

Tabell 6.6.3 Förändring av aneurysmstorlek och endoläckage

vid 24 månader ................................................. 210

6.7 AAA-relaterade sekundära ingrepp ............................... 210

Tabell 6.7.1 Sekundära ingrepp (till 12 månader) ................. 210

Tabell 6.7.2 Sekundära ingrepp (> 12 till 24 månader) ............ 210

6.8 Sekundära resultatmått .......................................... 211

Tabell 6.8.1 Sekundära resultat enligt behandlingsgrupp .........211

7 PATIENTURVAL OCH BEHANDLING .................................. 211

Individualisering av behandlingen ................................... 211

8 PATIENTRÅDGIVNING .............................................. 211

9 LEVERANSFORM ................................................... 211

10 INFORMATION OM KLINISK ANVÄNDNING ......................... 211

10.1 Läkarens utbildning ............................................. 211

10.2 Besiktning före användning ..................................... 211

10.3 Material som behövs ............................................ 211

10.4 Rekommenderat material ....................................... 211

10.5 Riktlinjer för dimensionering av anordningens diameter ......... 212

Tabell 10.5.1 Dimensioneringsguide för

huvudstomtransplantatets diameter ............................ 212

Tabell 10.5.2 Dimensioneringsguide för det iliakaliska

graftbenets diameter ........................................... 212

11 BRUKSANVISNING ................................................ 212

Anatomiska krav ..................................................... 212

Allmän information .................................................. 212

Avgöranden före implantation ....................................... 212

Förberedelse av patienten ........................................... 212

11.1 Bifurkerat system ...............................................212

11.1.1 Förberedelse/spolning av bifurkerad huvudstomme .......212

11.1.2 Förberedning/spolning av kontralateralt iliakaliskt

graftben ........................................................ 212

11.1.3 Förberedning/spolning av ipsilateralt iliakaliskt graftben .. 212

11.1.4 Kärlåtkomst och angiografi ............................... 212

11.1.5 Placering av huvudstomme ............................... 212

11.1.6 Placering av den kontralaterala iliakaliska ledaren ......... 212

11.1.7

Proximal (hög) utplacering av huvudstomme

11.1.8

Placering och utplacering av det kontralaterala iliakaliska

graftbenet

.........................................................213

11.1.9 Distal (botten) insättning av huvudstomme ................

11.1.10 Inkoppling av det övre skyddet ...........................

11.1.11

Placering och utplacering av det ipsilaterala iliakaliska

graftbenet

.......................................................

11.1.12 Införande av formningsballong ...........................

Slutligt angiogram ........................................

12 RIKTLINJER FÖR BILDFRAMSTÄLLNING OCH POSTOPERATIV

UPPFÖLJNING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213

12.1 Allmänt ..........................................................

Tabell 12.1 Rekommenderat bildtagningsschema för patienter

med endovaskulära implantat ................................... 214

12.2 Rekommendationer avseende DT med och utan kontrast ........ 214

Tabell 12.2 Godkända bildframställningsprotokoll ............... 214

12.3 Abdominala röntgenbilder ...................................... 214

12.4 Ultraljud ........................................................ 214

12.5 MRT-säkerhet och -kompabilitet ................................. 214

12.6 Ytterligare övervakning och behandling ......................... 214

13 PATIENTSPÅRNINGSINFORMATION ................................ 214

14 FELSÖKNING ........................................................214

14.1 Felsökning av frigöring av utlösningsstråden .......................

14.1.1 Proximal (hög) utplacering av huvudstomme ................

14.1.2 Inkoppling av det övre skyddet ..............................215

14.1.3 Placering och utplacering av det ipsilaterala iliakaliska

graftbenet .........................................................215

14.1.4 Placering och utplacering av det kontralaterala iliakaliska

graftbenet .........................................................215

14.2 Felsökning av utplacering av den suprarenala stenten. . . . . . . . . . . . . . 215

14.2.1 Proximal (hög) utplacering av huvudstomme ................215

14.2.2 Inkoppling av det övre skyddet ..............................215

14.2.3 Placering och utplacering av det ipsilaterala iliakaliska

graftbenet .........................................................215

14.2.4 Placering och utplacering av det kontralaterala iliakaliska

graftbenet .........................................................215

.............. 212

203 203

204

204 204

213 213

213 213 213

213

214 214

Illustrations • Ilustrace • Illustrationer • Abbildungen • Απεικονίσεις • Ilustraciones • Illustrations • Illusztrációk • Illustrazioni • Afbeeldingen • Illustrasjoner • Ilustracje • Ilustrações • Illustrationer

NOTE: The images in this section do not necessarily depict the actual sequence of procedures required to deploy this device. Please be

sure to reference the step-by-step instructions listed in Section 11 DIRECTIONS FOR USE and Section 14 TROUBLESHOOTING.

• POZNÁMKA:

• BEMÆRK: af dette produkt. Sørg for at henvise til trin-for-trin anvisningerne angivet i Afsnit 11 VEJLEDNING og Afsnit 14 FEJLSØGNING.

• HINWEIS:

παρουσιάζονται σε αυτή την ενότητα δεν απεικονίζουν απαραίτητα την πραγματική αλληλουχία των διαδικασιών που απαιτούνται

ΧΡΗΣΗΣ» και στην ενότητα 14 «ΑΝΤΙΜΕΤΩΠΙΣΗ ΠΡΟΒΛΗΜΑΤΩΝ».

ilustran la secuencia real de los procedimientos requeridos para desplegar este dispositivo. Asegúrese de consultar las instrucciones

paso a paso indicadas en el apartado 11, MODO DE EMPLEO, y el apartado 14, SOLUCIÓN DE PROBLEMAS.

dispositif. Veiller à consulter les instructions étape par étape indiquées dans la Section 11 DIRECTIVES D’UTILISATION et la Section

14 DÉPANNAGE. • MEGJEGYZÉS:

tényleges sorrendjét ábrázolják. Mindenképpen tekintse át a „11., HASZNÁLATI UTASÍTÁS” és a „14., HIBAKERESÉS” c. szakasz

lépésenkénti utasításait.

richieste per il rilascio di questo dispositivo. Fare riferimento alle istruzioni passo-passo elencate nella Sezione 11 ISTRUZIONI PER L’USO e nella Sezione 14 GUIDA ALLA RISOLUZIONE DEI PROBLEMI.

feitelijke volgorde van de procedures weer die nodig zijn om dit hulpmiddel te ontplooien. Raadpleeg de stapsgewijze instructies in

hoofdstuk 11, GEBRUIKSAANWIJZING, en hoofdstuk 14, OPLOSSEN VAN PROBLEMEN.

ikke nødvendigvis den faktiske sekvensen i prosedyrene som kreves for å anlegge denne anordningen. Sørg for å se trinn for trinn-

instruksjonene i avsnitt 11, BRUKSVEILEDNING, og avsnitt 14, FEILSØKING.

przedstawiają rzeczywistą kolejność procedur wymaganych do rozprężenia tego urządzenia. Należy koniecznie sprawdzić kolejne

instrukcje wyszczególnione w rozdziale 11, WSKAZANIA, i rozdziale 14, ROZWIĄZYWANIE PROBLEMÓW.

Certiﬁque-se de que consulta as instruções passo a passo na Secção 11 INSTRUÇÕES DE UTILIZAÇÃO e na Secção 14 RESOLUÇÃO

DE PROBLEMAS.

anordningen. Använd de stegvisa anvisningarna i avsnitt 11, BRUKSANVISNING, och avsnitt 14, FELSÖKNING, som referens.

Obrázky v této části nemusí nezbytně zobrazovat skutečné pořadí postupů vyžadovaných k rozvinutí tohoto zařízení.

Prostudujte si laskavě podrobné pokyny uvedené v části 11 POKYNY K POUŽITÍ a v části 14 ŘEŠENÍ PROBLÉMŮ.

Billederne i dette afsnit afbilder ikke nødvendigvis den faktiske rækkefølge af de påkrævede procedurer til anlæggelse

Die Bilder in diesem Abschnitt stellen nicht notwendigerweise die tatsächliche Reihenfolge der Verfahrensschritte

dar, die zur Entfaltung dieser Vorrichtung erforderlich sind. Die in Abschnitt 11 „Gebrauchsanweisung“ und in Abschnitt

14 „Fehlerbehebung“ aufgeführten Schritt-für-Schritt-Anleitungen müssen beachtet werden.

για την απελευθέρωση αυτής της συσκευής. Φροντίστε να ανατρέχετε στις οδηγίες βήμα-βήμα στην ενότητα 11 «ΟΔΗΓΙΕΣ

• NOTA:

Las imágenes de este apartado no necesariamente

• ΣΗΜΕΙΩΣΗ:

Les images dans cette section ne représentent pas nécessairement la séquence réelle des procédures requises pour déployer ce

A jelen szakaszban szereplő képek nem feltétlenül az eszköz kinyitásához szükséges eljárások

• NOTA -

Le immagini in questa sezione non illustrano necessariamente la sequenza eﬀettiva delle procedure

• NB:

De afbeeldingen in dit hoofdstuk geven niet per se de

• MERKNAD:

• UWAGA:

Ilustracje w tym rozdziale niekoniecznie

Bildene i dette avsnittet viser

desta secção não ilustram necessariamente a sequência real de procedimentos necessários para a expansão do dispositivo.

• OBS!

Bilderna i detta avsnitt återger inte nödvändigtvis den faktiska procedursekvens som krävs för att utplacera

Οι εικόνες που

• REMARQUE :

• NOTA:

As imagens

1. Iliac Legs

2. Gold Radiopaque Markers (4)

3. Suprarenal Stent

4. Main Body

5. Gold Radiopaque Marker

1. Iliakální ramena

2. Zlaté rentgenkontrastní značky (4)

3. Suprarenální stent

4. Hlavní tělo

5. Zlatá rentgenkontrastní značka

1. Iliaca-ben

2. Røntgenfaste guldmarkører (4)

3. Suprarenal stent

4. Hovedprotese

5. Røntgenfast guldmarkør

1. Iliakale Schenkel

2. Röntgendichte Goldmarkierungen (4)

3. Suprarenaler Stent

4. Hauptteil

5. Röntgendichte Goldmarkierung

1. Λαγόνια σκέλη

2. Χρυσοί ακτινοσκιεροί δείκτες (4)

3. Επινεφρική ενδοπρόσθεση

4. Κύριο σώμα

5. Χρυσός ακτινοσκιερός δείκτης

1. Ramas ilíacas

2. Marcadores radiopacos de oro (4)

3. Stent suprarrenal

4. Cuerpo principal

5. Marcador radiopaco de oro

1. Branches iliaques

2. Marqueurs radio-opaques en or (4)

3. Stent suprarénal

4. Corps principal

5. Marqueur radio-opaque en or

1. Iliaca-szárak

2. Arany sugárfogó markerek (4)

3. Suprarenális sztent

4. Fő graft-törzs

5. Arany sugárfogó marker

1. Branche iliache

2. Marker radiopachi d’oro (4)

3. Stent soprarenale

4. Corpo principale

5. Marker radiopaco d’oro

1. Iliacale poten

2. Gouden radiopake markeringen (4)

3. Suprarenale stent

4. Main body

5. Gouden radiopake markering

1. Iliaca-ben

2. Radioopake gullmarkører (4)

3. Suprarenal stent

4. Hoveddel

5. Radioopak gullmarkør

1. Odnogi biodrowe

2. Złote znaczniki cieniodajne (4)

3. Stent nadnerkowy

4. Główny trzon

5. Złoty znacznik cieniodajny

1. Extremidades ilíacas

2. Marcadores de ouro radiopacos (4)

3. Stent supra-renal

4. Corpo principal

5. Marcador de ouro radiopaco

1. Iliakaliskt graftben

2. Röntgentäta markeringar av guld (4)

3. Suprarenal stent

4. Huvudstomme

5. Röntgentät markering av guld

Fig. 1

1. Hub

2. Pin Vise

3. Safety Locks

4. Peel-Away® Sheath

5. Stopcock

6. Connecting Tube

7. Flexor® Introducer Sheath

8. Dilator Tip

9. Sheath Sideport

10. Captor® Hemostatic Valve

11. Gray Positioner

12. White Trigger-Wire Release Mechanism

13. Black Trigger-Wire Release Mechanism

14. Top Cap Inner Cannula

15. Endovascular Graft

1. Ústí

2. Svěrka

3. Pojistky

4. Sheath Peel-Away®

5. Uzavírací kohout

6. Spojovací hadička

7. Zaváděcí sheath Flexor®

8. Hrot dilatátoru

9. Boční port sheathu

10. Hemostatický ventil Captor®

11. Šedý polohovač

12. Bílá spoušť uvolňovacího drátu

13. Černá spoušť uvolňovacího drátu

14. Vnitřní kanyla horní čepičky

15. Endovaskulární graft

1. Muffe

2. Pin vise

3. Sikkerhedslåse

4. Peel-Away® sheath

5. Hane

6. Tilslutningsslange

7. Flexor® indføringssheath

8. Dilatatorspids

9. Sheath sideport

10. Captor® hæmostatisk ventil

11. Grå positioneringsanordning

12. Hvid udløsningsmekanisme for udløser-wire

13. Sort udløsningsmekanisme for udløser-wire

14. Tophættens indre kanyle

15. Endovaskulær protese

1. Ansatz

2. Klemmschraube

3. Sicherheitssperren

4. Peel-Away®-Schleuse

5. Absperrhahn

6. Verbindungsschlauch

7. Flexor®-Einführschleuse

8. Dilatatorspitze

9. Seitenport der Schleuse

10. Captor®-Hämostaseventil

11. Grauer Positionierer

12. Weißer Auslösedrahtmechanismus

13. Schwarzer Auslösedrahtmechanismus

14. Innere Kanüle der oberen Kappe

15. Endovaskuläre Prothese

1. Ομφαλός

2. Μέγγενη ακίδας

3. Ασφάλειες

4. Θηκάρι Peel-Away®

5. Στρόφιγγα

6. Σωλήνας σύνδεσης

7. Θηκάρι εισαγωγέα Flexor®

8. Άκρο διαστολέα

9. Πλευρική θύρα θηκαριού

10. Αιμοστατική βαλβίδα Captor®

11. Γκρι διάταξη τοποθέτησης

12. Λευκός μηχανισμός απελευθέρωσης σύρματος ενεργοποίησης

13. Μαύρος μηχανισμός απελευθέρωσης σύρματος ενεργοποίησης

14. Εσωτερική κάνουλα άνω πώματος

15. Ενδαγγειακό μόσχευμα

1. Conector

2. Manguito

3. Seguros

4. Vaina Peel-Away®

5. Llave de paso

6. Tubo conector

7. Vaina introductora Flexor®

8. Punta del dilatador

9. Orificio lateral de la vaina

10. Válvula hemostática Captor®

11. Posicionador gris

12. Mecanismo de liberación blanco mediante alambre disparador

13. Mecanismo de liberación negro mediante alambre disparador

14. Cánula interior de la cápsula superior

15. Endoprótesis vascular

1. Embase

2. Vis à broche

3. Verrous de sécurité

4. Gaine Peel-Away®

5. Robinet

6. Tube connecteur

7. Gaine d’introduction Flexor®

8. Extrémité du dilatateur

9. Orifice latéral de la gaine

10. Valve hémostatique Captor®

11. Positionneur gris

12. Mécanisme de largage blanc du guide de déclenchement

13. Mécanisme de largage noir du guide de déclenchement

14. Canule interne du capuchon supérieur

15. Endoprothèse vasculaire

1. Kónusz

2. Rögzítőelem

3. Biztosítózárak

4. Peel-Away® hüvely

5. Elzárócsap

6. Összekötőcső

7. Flexor® bevezetőhüvely

8. Dilatátor csúcsa

9. Hüvely oldalnyílása

10. Captor® vérzéscsillapító szelep

11. Szürke pozícionáló

12. Fehér elsütődrót-kioldószerkezet

13. Fekete elsütődrót-kioldószerkezet

14. Csúcsi sapka belső kanülje

15. Endovaszkuláris graft

1. Connettore

2. Morsetto

3. Blocchi di sicurezza

4. Guaina Peel-Away®

5. Rubinetto

6. Cannula di collegamento

7. Guaina di introduzione Flexor®

8. Punta del dilatatore

9. Foro laterale della guaina

10. Valvola emostatica Captor®

11. Posizionatore grigio

12. Meccanismo di rilascio bianco a filo di sicurezza

13. Meccanismo di rilascio nero a filo di sicurezza

14. Cannula interna della calotta superiore

15. Endoprotesi addominale

1. Aanzetstuk

2. Borgschroef

3. Veiligheidsvergrendelingen

4. Peel-Away® sheath

5. Afsluitkraan

6. Verbindingsslang

7. Flexor® introducer sheath

8. Dilatatortip

9. Zijpoort voor sheath

10. Captor® hemostatische klep

11. Grijze pusher

12. Wit mechanisme met trigger wire

13. Zwart vrijgavemechanisme met trigger wire

14. Binnenste canule van topkap

15. Endovasculaire prothese

1. Kanylefeste

2. Klemmeskrue

3. Sikkerhetslåser

4. Peel-Away® hylse

5. Stoppekran

6. Tilkoblingsslange

7. Flexor® innføringshylse

8. Dilatorspiss

9. Hylsens sidepor t

10. Captor® hemostaseventil

11. Grå posisjoneringsenhet

12. Hvit vaierutløsermekanisme

13. Svart vaierutløsermekanisme

14. Topphettens indre kanyle

15. Endovaskulært implantat

1. Złączka

2. Imadło sztyftowe

3. Blokady

4. Koszulka Peel-Away®

5. Kranik odcinający

6. Rurka łącząca

7. Koszulka wprowadzająca Flexor®

8. Końcówka rozszerzadła

9. Otwór boczny koszulki

10. Zastawka hemostatyczna Captor®

11. Szary pozycjoner

12. Biały mechanizm zwalniający drut

13. Czarny mechanizm zwalniający drut

14. Nasadka końcówki kaniuli wewnętrznej

15. Stent-graft wewnątrznaczyniowy

1. Conector

2. Pino de fixação

3. Dispositivos de segurança

4. Bainha Peel-Away®

5. Torneira de passagem

6. Tubo de ligação

7. Bainha introdutora Flexor®

8. Ponta dilatadora

9. Orifício lateral da bainha

10. Válvula hemostática Captor®

11. Posicionador cinzento

12. Mecanismo de libertação branco com fio de comando

13. Mecanismo de libertação preto com fio de comando

14. Cânula interior da tampa superior

15. Prótese endovascular

1. Fattning

2. Pin vise

3. Säkerhetslås

4. Peel-Away®-hylsa

5. Kran

6. Kopplingsslang

7. Flexor® införarhylsa

8. Dilatatorspets

9. Hylsans sidopor t

10. Captor® hemostasventil

11. Grå lägeställare

12. Vit utlösningstråds utlösningsmekanism

13. Svart utlösningstråds utlösningsmekanism

14. Övre skyddets inre kanyl

15. Endovaskulärt transplantat

Fig. 2

1. Hub

2. Pin Vise

3. Peel-Away® Sheath

4. Stopcock

5. Connecting Tube

6. Sheath

7. Dilator Tip

8. Sheath Sideport

9. Hemostatic Valve

10. Gray Positioner

11. Inner Cannula

12. Contralateral/Ipsilateral Endovascular Graft

1. Ústí

2. Svěrka

3. Sheath Peel-Away®

4. Uzavírací kohout

5. Spojovací hadička

6. Sheath

7. Hrot dilatátoru

8. Boční port sheathu

9. Hemostatický ventil

10. Šedý polohovač

11. Vnitřní kanyla

12. Kontralaterální/ipsilaterální endovaskulární graft

1. Muffe

2. Pin vise

3. Peel-Away® sheath

4. Hane

5. Tilslutningsslange

6. Sheath

7. Dilatatorspids

8. Sheath sideport

9. Hæmostatisk ventil

10. Grå positioneringsanordning

11. Indre kanyle

12. Kontralateral/ipsilateral endovaskulær protese

1. Ansatz

2. Klemmschraube

3. Peel-Away®-Schleuse

4. Absperrhahn

5. Verbindungsschlauch

6. Schleuse

7. Dilatatorspitze

8. Seitenport der Schleuse

9. Hämostaseventil

10. Grauer Positionierer

11. Innere Kanüle

12. Kontralaterale/ipsilaterale endovaskuläre Prothese

1. Ομφαλός

2. Μέγγενη ακίδας

3. Θηκάρι Peel-Away®

4. Στρόφιγγα

5. Σωλήνας σύνδεσης

6. Θηκάρι

7. Άκρο διαστολέα

8. Πλευρική θύρα θηκαριού

9. Αιμοστατική βαλβίδα

10. Γκρι διάταξη τοποθέτησης

11. Εσωτερική κάνουλα

12. Ετερόπλευρο/Σύστοιχο ενδαγγειακό μόσχευμα

1. Conector

2. Manguito

3. Vaina Peel-Away®

4. Llave de paso

5. Tubo conector

6. Vaina

7. Punta del dilatador

8. Orificio lateral de la vaina

9. Válvula hemostática

10. Posicionador gris

11. Cánula interior

12. Endoprótesis vascular contralateral/ipsilateral

1. Embase

2. Vis à broche

3. Gaine Peel-Away®

4. Robinet

5. Tube connecteur

6. Gaine

7. Extrémité du dilatateur

8. Orifice latéral de la gaine

9. Valve hémostatique

10. Positionneur gris

11. Canule interne

12. Endoprothèse vasculaire controlatérale/

1. Kónusz

2. Rögzítőelem

3. Peel-Away® hüvely

4. Elzárócsap

5. Összekötőcső

6. Hüvely

7. Dilatátor csúcsa

8. Hüvely oldalnyílása

9. Vérzéscsillapító szelep

10. Szürke pozícionáló

11. Belső kanül

12. Kontralaterális/ipsilaterális endovaszkuláris

1. Connettore

2. Morsetto

3. Guaina Peel-Away®

4. Rubinetto

5. Cannula di collegamento

6. Guaina

7. Punta del dilatatore

8. Foro laterale della guaina

9. Valvola emostatica

10. Posizionatore grigio

11. Cannula interna

12. Branca iliaca controlaterale/ipsilaterale

1. Aanzetstuk

2. Borgschroef

3. Peel-Away® sheath

4. Afsluitkraan

5. Verbindingsslang

6. Sheath

7. Dilatatortip

8. Zijpoort voor sheath

9. Hemostatische klep

10. Grijze pusher

11. Binnenste canule

12. Contralaterale/ipsilaterale endovasculaire

homolatérale

graft

dell’endoprotesi addominale

prothese

1. Kanylefeste

2. Klemmeskrue

3. Peel-Away® hylse

4. Stoppekran

5. Tilkoblingsslange

6. Hylse

7. Dilatorspiss

8. Hylsens sideport

9. Hemostaseventil

10. Grå posisjoneringsenhet

11. Indre kanyle

12. Kontralateral/ipsilateral endovaskulært

1. Złączka

2. Imadło sztyftowe

3. Koszulka Peel-Away®

4. Kranik odcinający

5. Rurka łącząca

6. Koszulka

7. Końcówka rozszerzadła

8. Otwór boczny koszulki

9. Zastawka hemostatyczna

10. Szary pozycjoner

11. Kaniula wewnętrzna

12. Stent-graft wewnątrznaczyniowy

1. Conector

2. Pino de fixação

3. Bainha Peel-Away®

4. Torneira de passagem

5. Tubo de ligação

6. Bainha

7. Ponta dilatadora

8. Orifício lateral da bainha

9. Válvula hemostática

10. Posicionador cinzento

11. Cânula interna

12. Prótese endovascular contralateral/

1. Fattning

2. Pin vise

3. Peel-Away®-hylsa

4. Kran

5. Kopplingsslang

6. Hylsa

7. Dilatatorspets

8. Hylsans sidoport

9. Hemostasventil

10. Grå lägeställare

11. Inre kanyl

12. Kontralateralt/ipsilateralt endovaskulärt

Fig. 3

implantat

przeciwstronny/tożsamostronny

homolateral

transplantat

1. Converter

2. Iliac Plug

3. Iliac Leg Extension

4. Main Body Extension

1. Přechodový díl

2. Iliakální zátka

3. Extenze iliakálního ramena

4. Extenze hlavního těla

1. Konverteringsenhed

2. Iliaca-prop

3. Iliaca-benforlænger

4. Hovedproteseforlænger

1. Konverter

2. Iliakales Verschluss-Segment

3. Iliakale Schenkelverlängerung

4. Verlängerung des Hauptteils

1. Μετατροπέας

2. Λαγόνιο βύσμα

3. Προέκταση λαγόνιου σκέλους

4. Προέκταση κύριου σώματος

Fig. 4

1. Convertidor

2. Tapón ilíaco

3. Extensión de rama ilíaca

4. Extensión de cuerpo principal

1. Convertisseur

2. Obturateur iliaque

3. Extension de branche iliaque

4. Extension de corps principal

1. Konverter

2. Iliaca-dugó

3. Iliaca-szár toldaléka

4. Fő graft-törzs toldaléka

1. Convertitore

2. Dispositivo di occlusione iliaca

3. Estensione della branca iliaca

4. Estensione del corpo principale

1. Converteerder

2. Iliacale plug

3. Verlengstuk voor iliacale poot

4. Verlengstuk voor main body

1. Konverteringsenhet

2. Iliaca-propp

3. Iliaca-benforlengelse

4. Hoveddelforlengelse

1. Konwerter

2. Wtyk biodrowy

3. Przedłużenie odnogi biodrowej

4. Przedłużenie głównego trzonu

1. Conversor

2. Tampão ilíaco

3. Extensão da extremidade ilíaca

4. Extensão do corpo principal

1. Konverterare

2. Iliakalisk plugg

3. Förlängning för iliakaliskt graftben

4. Förlängning för huvudstomme

Fig. 5

Fig. 6

Fig. 7

Fig. 8

Fig. 9

1. Small radiopaque markers provide top

(proximal) orientation of graft material. Long radiopaque marker aligns with contralateral limb.

2. Fluoroscopic Image

3. Top View Cross-Section

4. Anterior Contralateral Limb Orientation

5. Posterior Contralateral Limb Orientation

6. Lateral Contralateral Limb Orientation

7. Graft Positioning - Right Side Introduction

1. Malé rentgenkontrastní značky zajišťují

horní (proximální) orientaci materiálu graftu. Dlouhé rentgenkontrastní značky jsou na úrovni kontralaterální větve.

2. Rentgenový snímek

3. Průřez v pohledu shora

4. Přední orientace kontralaterální větve.

5. Zadní orientace kontralaterální větve.

6. Laterální orientace kontralaterální větve.

7. Polohování graftu – Zavedení z pravé strany

1. Små røntgenfaste markører giver top

(proksimal) orientering af protesemateriale. Lange røntgenfaste markører tilpasser sig med den kontralaterale kant.

2. Gennemlysningsbillede

3. Tværsnit set fra oven

4. Anterior orientering af kontralateral kant

5. Posterior orientering af kontralateral kant

6. Lateral orientering af kontralateral kant

7. Positionering af protese - Indføring i højre

side

1. Die kurzen röntgendichten Markierungen

geben die obere (proximale) Ausrichtung des Prothesenmaterials an. Die lange röntgendichte Markierung bildet eine Linie mit dem kontralateralen Ansatz.

2. Fluoroskopische Ansicht

3. Aufsicht Querschnitt

4. Anteriore Ausrichtung des kontralateralen

Ansatzes

5. Posteriore Ausrichtung des kontralateralen

Ansatzes

6. Laterale Ausrichtung des kontralateralen

Ansatzes

7. Positionierung der Prothese - Einführung

von rechts

1. Μικροί ακτινοσκιεροί δείκτες παρέχουν

άνω (εγγύς) προσανατολισμό του υλικού μοσχεύματος. Ο μακρός ακτινοσκιερός δείκτης ευθυγραμμίζεται με το ετερόπλευρο μέλος.

2. Ακτινοσκοπική εικόνα

3. Εγκάρσια διατομή άνω όψης

4. Πρόσθιος προσανατολισμός ετερόπλευρου

μέλους

5. Οπίσθιος προσανατολισμός ετερόπλευρου

μέλους

6. Πλευρικός προσανατολισμός ετερόπλευρου

μέλους

7. Τοποθέτηση μοσχεύματος - Εισαγωγή στη

δεξιά πλευρά

1. Los marcadores radiopacos pequeños indican la orientación superior (proximal) del material de la endoprótesis vascular. El marcador radiopaco largo se alinea con la ramificación contralateral.

2. Imagen fluoroscópica

3. Vista transversal superior

4. Orientación anterior de la ramificación contralateral

5. Orientación posterior de la ramificación contralateral

6. Orientación lateral de la ramificación contralateral

7. Colocación de la endoprótesis vascular:

introducción por el lado derecho

1. Les petits marqueurs radio-opaques indiquent l’orientation supérieure proximale de l’endoprothèse. Le marqueur radio-opaque long s’aligne avec le membre controlatéral.

2. Image radioscopique

3. Section transversale vue en plan

4. Orientation du membre controlatéral antérieur

5. Orientation du membre controlatéral postérieur

6. Orientation du membre controlatéral latéral

7. Positionnement de l’endoprothèse

-Introduction du côté droit

1. A kis sugárfogó markerek lehetővé teszik a graft anyagának csúcsi (proximális) orientációját. A hosszú sugárfogó marker a kontralaterális ággal kerül egy vonalba.

2. Fluoroszkópos kép

3. Felülnézeti keresztmetszet

4. Kontralaterális ág anterior orientációja

5. Kontralaterális ág posterior orientációja

6. Kontralaterális ág lateralis orientációja

7. Graft pozícionálása – jobb oldali felvezetés

1. Piccoli marker radiopachi consentono di rilevare l’orientamento della parte superiore (prossimale) del materiale di rivestimento dell’endoprotesi. Il marker radiopaco lungo si allinea con l’estremità controlaterale.

2. Immagine fluoroscopica

3. Vista superiore, sezione trasversale

4. Orientamento anteriore dell’estremità controlaterale

5. Orientamento posteriore dell’estremità controlaterale

6. Orientamento laterale dell’estremità controlaterale

7. Posizionamento dell’endoprotesi -

Inserimento dal lato destro

1. Kleine radiopake markeringen worden gebruikt voor oriëntatie van de (proximale) bovenkant van het prothesemateriaal. De lange radiopake markering ligt in één lijn met de contralaterale stomp.

2. Fluoroscopisch beeld

3. Bovenaanzicht dwarsdoorsnede

4. Anterieure oriëntatie contralaterale stomp

5. Posterieure oriëntatie contralaterale stomp

6. Laterale oriëntatie contralaterale stomp

7. Positioneren van de prothese - Introduceren

via de rechterzijde

Fig. 10

1. Små radioopake markører gir toppdel (proksimal)-orientering av implantatmaterialet. Lang radioopak markør stilles på linje med kontralateralt lem.

2. Fluoroskopisk bilde

3. Tverrsnitt sett ovenifra

4. Anterior orientering av kontralateralt lem

5. Posterior orientering av kontralateralt lem

6. Lateral orientering av kontralateralt lem

7. Implantatplassering - Innføring høyre side

1. Małe znaczniki cieniodajne zapewniają identyfikację górnej (proksymalnej) części tworzywa stent-graftu. Długi znacznik cieniodajny zrównuje się z odgałęzieniem przeciwstronnym.

2. Obraz fluoroskopowy

3. Przekrój poprzeczny widziany od góry

4. Ustawienie przednie przeciwstronnego odgałęzienia

5. Ustawienie tylne przeciwstronnego odgałęzienia

6. Ustawienie boczne przeciwstronnego odgałęzienia

7. Ustawianie stent-graftu – wprowadzenie

z prawej strony

1. Pequenos marcadores radiopacos fornecem a orientação do topo (proximal) do material da prótese. Marcador radiopaco longo alinha-se com o ramo contralateral.

2. Imagem fluoroscópica

3. Secção transversal da vista superior

4. Orientação anterior do ramo contralateral

5. Orientação posterior do ramo contralateral

6. Orientação lateral do ramo contralateral

7. Posicionamento da prótese - Introdução do

lado direito

1. Små röntgentäta markeringar anger toppläget (proximalt) för transplantationsmaterialet. Den långa röntgentäta markeringen riktar in sig i linje med den kontralaterala lemmen.

2. Fluoroskopisk bild

3. Tvärsnitt uppifrån

4. Den främre kontralaterala lemmens orientering

5. Den bakre kontralaterala lemmens orientering

6. Den laterala kontralaterala lemmens orientering

7. Transplantatplacering - Införing från högra

sidan

Fig. 11 Fig. 12

Fig. 14 Fig. 15 Fig. 16

Fig. 13

Fig. 17 Fig. 18 Fig. 19

Fig. 20

Fig. 21 Fig. 22

Fig. 23 Fig. 24 Fig. 25

Fig. 26 Fig. 27

Fig. 28

Fig. 29

Fig. 30

Fig. 32 Fig. 33

Fig. 31

Fig. 36

Fig. 35Fig. 34

1. Balloon Expansion/Graft Sealing Sites

1. Expanze balónku/místa utěsnění graftu

1. Ballonekspansion/ proteseforseglingssteder

1. Ballonafweitungs-/ Prothesendichtungsstellen

1. Θέσεις διαστολής μπαλονιού/ στεγανοποίησης μοσχεύματος

1. Lugares de hinchado del balón y sellado de la endoprótesis vascular

1. Sites de gonflage du ballonnet et d’étanchéité de l’endoprothèse

1. Ballon feltöltés/graft tapadási helyei

1. Siti di dilatazione del palloncino/ fissazione dell’endoprotesi

1. Plaatsen voor ballonexpansie/ protheseafdichting

1. Ballongekspansjons-/ implantatforseglingssteder

1. Miejsca rozprężania balonu/ uszczelniania stent-graftu

1. Locais de expansão do balão/selagem da prótese

1. Ballongexpansion/transplantatets tätningsställen

Troubleshooting (Section 14) • Řešení problémů (část 14) • Fejlsøgning (Afsnit 14) • Fehlerbehebung (Abschnitt 14)

• Αντιμετώπιση προβλημάτων (ενότητα 14) • Solución de problemas (apartado 14) • Dépannage (Section 14) • Hibakeresés (14. szakasz)

• Guida alla risoluzione dei problemi (Sezione 14) • Oplossen van problemen (hoofdstuk 14) • Feilsøking (avsnitt 14) • Rozwiązywanie problemów (rozdział 14) • Resolução de problemas (secção 14) • Felsökning (avsnitt 14)

Fig. 37

Fig. 38

Fig. 39

Fig. 40

1. View of trigger-wire under tension

1. Pohled na napjatý uvolňovací drát

1. Visning af udløser-wiren under spænding

1. Ansicht des Auslösedrahts unter Zugspannung

1. Άποψη του σύρματος ενεργοποίησης υπό τάση

1. Vista del alambre disparador tenso

1. Vue du guide de déclenchement sous tension

1. A megfeszített elsütődrót képe

1. Vista del ﬁlo di sicurezza teso

1. Aanzicht van trigger wire onder spanning

1. Visning av stram utløservaier

1. Widok naprężonego drutu zwalniającego

1. Vista do ﬁo de comando sob tensão

1. Bild av sträckt utlösningstråd

Troubleshooting (Section 14) • Řešení problémů (část 14) • Fejlsøgning (Afsnit 14) • Fehlerbehebung (Abschnitt 14)

• Αντιμετώπιση προβλημάτων (ενότητα 14) • Solución de problemas (apartado 14) • Dépannage (Section 14) • Hibakeresés (14. szakasz)

1. View of trigger-wire with inner cannula retracted, releasing tension

1. Pohled na uvolňovací drát s vnitřní kanylou staženou zpět, což uvolňuje napětí

1. Visning af udløser-wiren med den indre kanyle trukket tilbage, mens den frigør spænding

1. Ansicht des entspannten Auslösedrahts bei zurückgezogener innerer Kanüle

1. Άποψη του σύρματος ενεργοποίησης με αποσυρμένη την εσωτερική κάνουλα, εκτόνωση τάσης

1. Vista del alambre disparador con la cánula interior retraída, lo que destensa el alambre

1. Vue du guide de déclenchement avec la canule interne tirée vers l’arrière pour relâcher la tension

1. Az elsütődrót képe a feszítést megszüntető visszahúzott belső kanüllel

1. Vista del ﬁlo di sicurezza con la cannula interna retratta; il ﬁlo è allentato

1. Aanzicht van trigger wire met binnenste canule teruggetrokken om spanning te verminderen

1. Visning av slakk utløservaier med indre kanyle trukket tilbake

1. Widok drutu zwalniającego z wycofaną kaniulą wewnętrzną, przy zwolnionym naprężeniu

1. Vista do ﬁo de comando com cânula interior recuada, aliviando a tensão

1. Bild av utlösningstråd med tillbakadragen inre kanyl,

Fig. 41

vilket ger minskad sträckning

Fig. 42

Fig. 43

Fig. 44

Fig. 45

Troubleshooting (Section 14) • Řešení problémů (část 14) • Fejlsøgning (Afsnit 14) • Fehlerbehebung (Abschnitt 14)

• Αντιμετώπιση προβλημάτων (ενότητα 14) • Solución de problemas (apartado 14) • Dépannage (Section 14) • Hibakeresés (14. szakasz)

Fig. 46

Fig. 47

Fig. 48

Fig. 49

Fig. 50

Fig. 51

Troubleshooting (Section 14) • Řešení problémů (část 14) • Fejlsøgning (Afsnit 14) • Fehlerbehebung (Abschnitt 14)

• Αντιμετώπιση προβλημάτων (ενότητα 14) • Solución de problemas (apartado 14) • Dépannage (Section 14) • Hibakeresés (14. szakasz)

Fig. 52

ENGLISH

ZENITH FLEX® AAA ENDOVASCULAR GRAFT WITH THE H&L-B ONE-SHOT™ INTRODUCTION SYSTEM

Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions may lead to serious surgical consequences or injury to the patient.

CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

CAUTION: All contents of the outer pouch (including the introduction system and the endovascular grafts) are supplied sterile, for single use only.

For the Zenith product line there are four applicable Suggested Instructions for Use (IFU). This IFU describes the Suggested Instructions for Use for the Zenith Flex AAA Endovascular Graft (main body and iliac legs). For information on other Zenith components, please refer to the following Suggested Instructions for Use:

• Zenith AAA Endovascular Graft (Zenith AAA Endovascular Graft main body and iliac legs);

• Zenith AAA Endovascular Graft Ancillar y Components (main body extension, iliac leg extension, converter and iliac plug);

• Zenith® Renu™ AAA Ancillary Graft (main body extension and converter configurations); and

• CODA® Balloon Catheter.

1 DEVICE DESCRIPTION

1.1 Aortic Main Body and Iliac Leg Components

The Zenith Flex AAA Endovascular Graft is a modular system consisting of three components, a bifurcated aortic main body and two iliac legs. (Fig. 1) The graft modules are constructed of full-thickness woven polyester fabric sewn to self-expanding stainless steel Cook-Z® stents with braided polyester and monoﬁlament polypropylene suture. The modules are fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. Additionally, the Cook-Z stents provide the necessary attachment and seal of the graft to the vessel wall.

The bare suprarenal stent at the proximal end of the graft contains barbs that are placed at 3 mm increments for additional ﬁxation of the device. To facilitate ﬂuoroscopic visualization of the stent graft, gold radiopaque markers are positioned as follows: one on the lateral aspect of the most distal stent on the contralate ral limb of the bifurcated section of the main body and four in a circumferential orientation within 2 mm of the most superior aspect of the graft material.

1.2 Main Body Delivery System

The Zenith Flex AAA Endovascular Graft main body is shipped preloaded onto the H&L-B One-Shot Introduction System. (Fig. 2) It has a sequential deployment method with built-in features to provide continuous control of the endovascular graft throughout the deployment procedure. The H&L-B One-Shot Introduction System is designed for precise positioning and allows readjustment of the ﬁnal graft position before deployment of the barbed suprarenal stent.

The main body graft delivery system uses an 18, 20 or 22 French H&L-B OneShot Introduction System. Dual trigger-wire release mechanisms lock the endovascular graft onto the delivery system until released by the physician. All systems are compatible with a .035 inch wire guide.

For added hemostasis, the Captor® Hemostatic Valve can be loosened or tightened for the introduction and/or removal of ancillary devices into and out of the sheath. The main body delivery systems feature a Flexor® introducer sheath which resists kinking and is hydrophilically coated. Both features are intended to enhance trackability in the iliac arteries and abdominal aorta.

1.3 Iliac Leg Delivery System

The Zenith AAA Endovascular Graft iliac legs are shipped preloaded onto the H&L-B One-Shot Introduction System. (Fig. 3) The delivery system is designed for ease of use with minimal preparation. The iliac leg delivery system uses a 14 or 16 French H&L-B One-Shot Introduction System. All systems are compatible with a .035 inch wire guide.

1.4 Zenith AAA Endovascular Graft Ancillary Components

Additional ancillary endovascular components (main body extensions, iliac leg extensions, converters and iliac plugs) are available. (Fig. 4) Refer to the Zenith AAA Endovascular Graft Ancillary Components Instructions for Use for more information.

2 INDICATIONS FOR USE

The Zenith Flex AAA Endovascular Graft with the H&L-B One-Shot Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair, including:

• Adequate iliac/femoral access compatible with the required introduction systems,

• Non-aneur ysmal infrarenal aortic segment (neck) proximal to the aneurysm:

• with a length of at least 15 mm,

• with a diameter measured outer wall to outer wall of no greater than 32 mm and no less than 18 mm,

• with an angle less than 60 degrees relative to the long axis of the aneurysm, and

• with an angle less than 45 degrees relative to the axis of the suprarenal aorta.

• I liac artery distal fixation site greater than 10 mm in length and 7.5-20 mm in diameter (measured outer wall to outer wall).

3 CONTRAINDICATIONS

There are no known contraindications for these devices.

4 WARNINGS AND PRECAUTIONS

4.1 General

• Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient.

• Always have a qualified surgery team available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary.

• The Zenith Flex AAA Endovascular Graft with the H&L-B One-Shot Introduction System should only be used by physicians and teams trained in vascular interventional techniques (catheter-based and surgical) and in the use of this device. Specific training expectations are described in Section

10.1, Physician Training.

• Additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging aneurysm, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak. An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.

• Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures.

4.2 Patient Selection, Treatment and Follow-Up

• The Zenith Flex AAA Endovascular Graft is designed to treat aortic neck diameters no smaller than 18 mm and no larger than 32 mm. The Zenith Flex AAA Endovascular Graft is designed to treat proximal aortic necks (distal to the lowest renal artery) of at least 15 mm in length. Iliac artery distal fixation site greater than 10 mm in length and 7.5 - 20 mm in diameter (measured outer wall to outer wall) is required. These sizing measurements are critical to the performance of the endovascular repair.

• Key anatomical elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (>60 degrees for infrarenal neck to axis of AAA or >45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic neck (<15 mm); an inverted funnel shape (greater than 10% increase in diameter over 15 mm of proximal aortic neck length); and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. In the presence of anatomical limitations, a longer neck may be required to obtain adequate sealing and fixation. Irregular calcification and/or plaque may compromise the attachment and sealing at the fixation sites. Necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.

• Adequate iliac or femoral access is required to introduce the device into the vasculature. Access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease and/or calcification) should be compatible with vascular access techniques and delivery systems of a 16 French to 22 French vascular introducer sheath. Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization. A vascular conduit technique may be necessary to achieve success in some patients.

• The Zenith Flex AAA Endovascular Graft with the H&L-B One-Shot Introduction System is not recommended in patients who cannot tolerate contrast agents necessary for intraoperative and postoperative follow-up imaging. All patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis.

• The Zenith Flex AAA Endovascular Graft with the H&L-B One-Shot Introduction System is not recommended in patients exceeding weight and/or size limits which compromise or prevent the necessary imaging requirements.

• I nability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvic/bowel ischemia.

• Multiple large, patent lumbar arteries, mural thrombus and a patent inferior mesenteric artery may all predispose a patient to Type II endoleaks. Patients with uncorrectable coagulopathy may also have an increased risk of Type II endoleak or bleeding complications.

• The safety and effectiveness of the Zenith Flex AAA Endovascular Graft with the H&L-B One-Shot Introduction System has not been evaluated in the following patient populations:

• traumatic aor tic injury

• leak ing, pending rupture or ruptured aneurysms

• mycotic aneurysms

• pseudoaneur ysms resulting from previous graft placement

• revision of previously placed endovascular grafts

• uncorrectable coagulopathy

• indispensable mesenteric ar tery

• genetic connec tive tissue disease (e.g., Marfans or Ehlers-Danlos Syndromes)

• concomitant thoracic aortic or thoracoabdominal aneur ysms

• patients with active systemic infections

• pregnant or nursing females

• morbidly obese patients

• less than 18 years of age

• patients with less than 15 mm in length or greater than 60 degrees angulation of the proximal aortic neck relative to the long axis of the aneurysm.

• Successful patient selection requires specific imaging and accurate

measurements; please see Section 4.3 Pre-Procedure Measurement

Techniques and Imaging.

• All lengths and diameters of the devices necessar y to complete the procedure should be available to the physician, especially when preoperative case planning measurements (treatment diameters/lengths) are not certain. This approach allows for greater intraoperative flexibility to achieve optimal procedural outcomes.

4.3 Pre-Procedure Measurement Techniques and Imaging

• Lack of non- contrast CT imaging may result in failure to appreciate iliac or aortic calcification, which may preclude access or reliable device fixation and seal.

• Pre-procedure imaging reconstruction thicknesses >3 mm may result in sub-optimal device sizing, or in failure to appreciate focal stenoses from CT.

• Clinical experience indicates that contrast-enhanced spiral computed tomographic angiography (CTA) with 3-D reconstruction is the strongly recommended imaging modality to accurately assess patient anatomy prior to treatment with the Zenith Flex AAA Endovascular Graft. If contrastenhanced spiral CTA with 3-D reconstruction is not available, the patient should be referred to a facility with these capabilities.

• Clinicians recommend positioning the x-ray C-arm during procedural angiography such that the origins of the renal arteries, and particularly the lowest patent renal artery, are well demonstrated prior to deployment of the proximal edge of the graft material (sealing stent) of the main body. Additionally, angiography should demonstrate the iliac artery bifurcations such that the distal common iliacs are well defined relative to the origin of the internal iliac arteries bilaterally, prior to deployment of the iliac leg components.

Diameters:

Utilizing CT, diameter measurements should be determined from the outer wall to outer wall vessel diameter (not lumen measurement) to help with proper device sizing and device selection. The contrast-enhanced spiral CT scan must start 1 cm superior to the celiac axis and continue through the femoral heads at an axial thickness slice of 3 mm or less.

Lengths:

Utilizing CT, length measurements should be determined to accurately assess infrarenal proximal neck length as well as planning main body sizes and leg components for the Zenith Flex AAA Endovascular Graft. These reconstructions should be performed in sagittal, coronal, and 3-D.

• The long-term per formance of endovascular grafts has not yet been

established. All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft. Patients with specific

clinical findings (e.g., endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up. Specific follow-up guidelines are described in Section 12,

IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP.

• The Zenith Flex AAA Endovascular Graft with the H&L-B One-Shot Introduction System is not recommended in patients unable to undergo, or who will not be compliant with, the necessary preoperative and postoperative imaging and implantation studies as described in Section 12,

IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP.

• After endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft. At a minimum, annual imaging is required, including: 1) abdominal radiographs to examine device integrity (separation between components, stent fracture or barb separation) and 2) contrast and non-contrast CT to examine aneurysm changes, perigraft flow, patency, tortuosity and progressive disease. If renal complications or other factors preclude the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information.

4.4 Device Selection

• Stric t adherence to the Zenith Flex AAA Endovascular Graft IFU sizing guide is strongly recommended when selecting the appropriate device size (Tables 10.5.1 and 10.5.2). Appropriate device oversizing has been incorporated into the IFU sizing guide. Sizing outside of this range can result in endoleak, fracture, migration, device infolding or compression.

4.5 Implant Procedure

(Refer to Section 11, DIRECTIONS FOR USE)

• Appropriate procedural imaging is required to successfully position the Zenith Flex AAA Endovascular Graft and assure accurate apposition to the aortic wall.

• Do not bend or k ink the delivery system. Doing so may cause damage to the delivery system and the Zenith Flex AAA Endovascular Graft.

• To avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).

• Do not continue advancing any portion of the deliver y system if resistance is felt during advancement of the wire guide or delivery system. Stop and assess the cause of resistance; vessel, catheter or graft damage may occur. Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or tortuous vessels.

• I nadvertent partial deployment or migration of the endoprosthesis may require surgical removal.

• Unless medically indicated, do not deploy the Zenith Flex AAA Endovascular Graft in a location that will occlude arteries necessary to supply blood flow to organs or extremities. Do not cover significant renal or mesenteric arteries (exception is the inferior mesenteric artery) with the endoprosthesis. Vessel occlusion may occur. During the clinical study, this device was not studied in patients with two occluded internal iliac arteries.

• Do not attempt to re -sheath the graft after partial or complete deployment.

• Repositioning the stent graft distally after par tial deployment of the covered proximal stent may result in damage to the stent graft and/or vessel injury.

• I naccurate placement and/or incomplete sealing of the Zenith Flex AAA Endovascular Graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries. Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.

• I nadequate fixation of the Zenith Flex AAA Endovascular Graft may result in increased risk of migration of the stent graft. Incorrect deployment or migration of the endoprosthesis may require surgical intervention.

• Systemic anticoagulation should be used during the implantation procedure based on hospital and physician preferred protocol. If heparin is contraindicated, an alternative anticoagulant should be considered.

• To activate the hydrophilic coating on the outside of the Flexor introducer sheath, the surface must be wiped with sterile gauze pads soaked in saline solution. Always keep the sheath hydrated for optimal performance.

• M inimize handling of the constrained endoprosthesis during preparation and insertion to decrease the risk of endoprosthesis contamination and infection.

• M aintain wire guide position during delivery system insertion.

• Fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome.

• The use of the Zenith Flex AAA Endovascular Graft with the H&L-B One-Shot Introduction System requires administration of intravascular contrast. Patients with preexisting renal insufficiency may have an increased risk of renal failure postoperatively. Care should be taken to limit the amount of contrast media used during the procedure and to observe preventative methods of treatment to decrease renal compromise (e.g., adequate hydration).

• As the sheath and/or wire guide is withdrawn, anatomy and graft position may change. Constantly monitor graft position and perform angiography to check position as necessary.

• The Zenith Flex AAA Endovascular Graft incorporates a suprarenal stent with fixation barbs. Exercise extreme caution when manipulating interventional and angiographic devices in the region of the suprarenal stent.

• Use caution during manipulation of catheters, wires and sheaths within an aneurysm. Significant disturbances may dislodge fragments of thrombus, which can cause distal embolization, or rupture of the aneurysm.

• Avoid damaging the graft or disturbing graft positioning after placement in the event reinstrumentation (secondary intervention) of the graft is necessary.

• Before deployment of the suprarenal stent, verify that the position of the access wire guide extends just distal to the aortic arch.

• Verify that the predetermined contralateral iliac leg is selected for insertion on the contralateral side of the patient before implantation.

4.6 Molding Balloon Use

• Do not inflate the balloon in the vessel outside of the graft, as doing so may cause damage to the vessel. Use the balloon in accordance with its labeling.

• Use care in inflating the balloon within the graft in the presence of calcification, as excessive inflation may cause damage to the vessel.

• Confirm complete deflation of the balloon prior to repositioning.

• For added hemostasis, the Captor Hemostatic Valve can be loosened or tightened to accommodate the insertion and subsequent withdrawal of a molding balloon.

4.7 MRI Safety and Compatibility

Non-clinical testing has demonstrated that the Zenith AAA Endovascular Graft is MR Conditional. It can be scanned safely under the following conditions:

1.5 Tesla Systems:

• Static magnetic field of 1.5 Tesla

• Spatial gradient field of 450 Gauss/cm

• M aximum whole-body-averaged specific absorption rate (SAR) of

2.0 W/kg for 15 minutes of scanning

In non-clinical testing, the Zenith AAA Endovascular Graft produced a temperature rise of less than or equal to 1.4 °C at a maximum whole-bodyaveraged speciﬁc absorption rate (SAR) of 2.8 W/kg, as assessed by calorimetry for 15 minutes of MR scanning in a 1.5 Tesla M agnetom, Siemens Medical Magnetom, Numaris/4 Software, Version Syngo MR 2002B DHHS MR Scanner. The maximum whole-body-averaged speciﬁc absorption rate (SAR) was 2.8 W/ kg, which corresponds to a calorimetry measured value of 1.5 W/kg.

3.0 Tesla Systems:

• Static magnetic field of 3.0 Tesla

• Spatial gradient field of 720 Gauss/cm

• M aximum whole-body-averaged specific absorption rate (SAR) of

2.0 W/kg for 15 minutes of scanning

In non-clinical testing, the Zenith AAA Endovascular Graft produced a temperature rise of less than or equal to 1.9 °C at a maximum wholebody-averaged speciﬁc absorption rate (SAR) of 3.0 W/kg, as assessed by calorimetry for 15 minutes of MR scanning in a 3.0 Tesla Excite, GE Electric Healthcare, G3.0-052B Software, MR Scanner. The maximum whole-bodyaveraged speciﬁc absorption rate (SAR) was 3.0 W/kg, which corresponds to a calorimetry measured value of 2.8 W/kg.

The image artifact extends throughout the anatomical region containing the device, obscuring the view of immediately adjacent anatomical structures within approximately 20 cm of the device, as well as the entire device and its lumen, when scanned in non-clinical testing using the sequence: Fast spin echo, in a 3.0 Tesla, Excite, GE Electric Healthcare, with G3.0-052B Software, MR system with body radiofrequency coil.

For all scanners, the image artifact dissipates as the distance from the device to the area of interest increases. MR scans of the head and neck and lower extremities may be obtained without image artifact. Image artifact may be present in scans of the abdominal region and upper extremities, depending on distance from the device to the area of interest.

Clinical information is available for seventeen patients who received MRI scans after stent-graft implantation. There have been no reported adverse events or device problems in any of these patients as a result of having received an MRI. Additionally, there have been well over 50,000 Zenith AAA Endovascular Grafts implanted worldwide, in which there have been no reported adverse events or device problems as a result of MRI.

Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:

Address: MedicAlert Foundation International

Fax: +1 209-669-2450 Web: www.medicalert.org

2323 Colorado Avenue Turlock, CA 95382 USA

Phone: 888-633-4298 (toll free)

+1 209-668-3333 from outside the US

5 ADVERSE EVENTS

5.1 Observed Adverse Events

A U.S. multicenter, prospective study of a previous version of the device (Zenith AAA Endovascular Graft) conducted at 15 centers which included 352 endovascular patients (200 standard risk, 100 high risk and 52 roll-in) and 80 control patients provides the basis of the observed adverse event rates in Table 5.1.1. Patients were enrolled in the standard risk arm if they were physiologically capable of withstanding an open or endovascular repair and had anatomy suitable for treatment with the Zenith AAA Endovascular Graft with the H&L-B One-Shot Introduction System. Patients with suitable anatomy, but at higher risk of morbidity or mortality with open repair were enrolled into the high risk arm. Initial patients treated in the study were enrolled in the roll-in arm. The control group included patients whose vascular anatomy may not have been suitable for endovascular AAA repair.

Table 5.1.1 Death and Rupture from Clinical Study

Death and Rupture Zenith Standard Risk

All death

(0-30 days)

(31-365 days)

AAA-related 0.0% (0/198) 1.3% (1/78) .29 3.1% (3/98) 0.0% (0/51) Non-AAA-related 3.0% (6/198) 0.0% (0/78) .19 4.1% (4/98) 9.8% (5/51)

2,3,4

(0-365 days)

AAA-related 0.5% (1/199) 3.8% (3/80) .07 5.0% (5/100) 1.9% (1/52) Non-AAA-related 3.0% (6/199) 0.0% (0/80) .19 4.0% (4/100) 9.6% (5/52)

Rupture

(0-30 days) 0.0% (0/199) n/a n/a 0.0% (0/100) 0.0% (0/52) (31-365 days) 0.0% (0/198) n/a n/a 1.0% (1/98) 0.0% (0/51) (0-365 days) 0.0% (0/199) n/a n/a 1.0% (1/100) 0.0% (0/52)

Denominator of 199 because one standard risk patient did not receive a device.

All deaths (0-30 days) were considered AAA and procedure related.

Of the deaths (31-365 days), four were considered AAA related: 1 surgical (septic shock from ischemic colitis) and 3 high risk (pancreatitis with renal failure and sepsis, hemorrhage

from upper abdominal aneurysm [not treated AAA] and multiple system failure).

Of the deaths (0-365 days), ten were considered AAA related: 1 standard risk (cardiac failure), 3 surgical (massive hemorrhage, mesenteric ischemia and septic shock from ischemic colitis), 5 high risk (respiratory failure, cardiac failure with pulmonary embolism, pancreatitis with renal failure and sepsis, hemorrhage from upper abdominal aneurysm [not treated AAA] and multiple system failure) and 1 roll-in (suspected cardiac failure).

0.5% (1/199) 2.5% (2/80) .20 2.0% (2/100) 1.9% (1/52)

3.0% (6/198) 1.3% (1/78) .68 7.1% (7/98) 9.8% (5/51)

3.5% (7/199) 3.8% (3/80) >.99 9.0% (9/100) 11.5% (6/52)

Surgical Standard Risk P value Zenith High Risk Zenith Roll-in

Zenith Standard Risk Surgical Standard Risk P value Zenith High Risk Zenith Roll-in

Table 5.1.2 Adverse Events1 in Clinical Study

Freedom from Morbidity

(0-30 days)

4, 9

8,11

(31-365 days)

4, 10

(0-365 days)

4, 9,10

8,11

Cardiovascular Pulmonary Renal Bowel Wound Neurologic Vascular Freedom from Morbidity

Cardiovascular Pulmonary Renal Bowel Wound Neurologic Vascular

From the morbidity index.

Cardiovascular included: Q-wave and non-Q-wave myocardial infarctions, congestive heart failure, arrhythmias requiring new medication or treatment, cardiac ischemia requiring

intervention, inotropic support, medically intractable hypertension.

Pulmonary included: reintubation or ventilation >24 hours, pneumonia requiring antibiotics, supplemental oxygen at discharge.

Renal included: dialysis in patients with normal preoperative renal function, creatinine rise >30% from baseline on two or more follow-up tests.

Bowel included: bowel obstruction, bowel ischemia, aorto-enteric fistula, paralytic ileus >4 days.

Wound included: infection requiring antibiotic treatment, hernia, lymph fistula, dehiscence, necrosis requiring debridement.

Neurological included: stroke, TIA, spinal cord ischemia/paralysis.

Vascular included: limb thrombosis, distal embolization resulting in tissue loss or requiring intervention, transfusion postprocedure (resulting from pseudoaneurysm, vascular injury, aneurysm leak or other procedure-related causes), pseudoaneurysm, vascular injury (such as inadvertent occlusion, dissection or other procedure related causes), aneurysm leak or rupture, increase in aneurysm size by more than 0.5 cm relative to the smallest of any prior measurement.

Investigators reported one additional high risk patient to have occlusion of an accessory renal artery and one additional high risk patient to have chronic renal insufficiency as “other” adverse events.

Investigators reported one additional roll-in patient to have renal insufficiency and one additional surgical patient to have renal insufficiency as “other” adverse events.

Investigators reported one additional roll-in patient to have experienced intraoperative aortic plaque rupture resulting in renal artery occlusion as an “other” adverse event.

80% (160/200) 58% (46/80) <.001 68% (68/100) 73% (38/52)

3.0% (6/200) 11% (9/80) .02 14% (14/100) 1.9% (1/52)

1.0% (2/200) 15% (12/80) <.001 2.0% (2/100) 0.0% (0/52)

2.5% (5/200) 10% (8/80) .01 6.0% (6/100) 5.8% (3/52)

1.0% (2/200) 3.8% (3/80) .14 1.0% (1/100) 1.9% (1/52)

4.5% (9/200) 7.5% (6/80) .38 2.0% (2/100) 3.8% (2/52)

0.0% (0/200) 2.5% (2/80) .08 0.0% (0/100) 0.0% (0/52) 11% (21/200) 31% (25/80) <.001 20% (20/100) 19% (10/52)

91% (181/198) 86% (67/78) .25 79% (77/98) 86% (44/51)

2.5% (5/198) 3.8% (3/78) .69 5.1% (5/98) 2.0% (1/51)

0.5% (1/198) 1.3% (1/78) .49 4.1% (4/98) 0.0% (0/51)

0.5% (1/198) 0.0% (0/78) >.99 3.1% (3/98) 0.0% (0/51)

0.5% (1/198) 1.3% (1/78) .49 0.0% (0/98) 0.0% (0/51)

2.0% (4/198) 5.1% (4/78) .23 3.1% (3/98) 2.0% (1/51)

1.0% (2/198) 0.0% (0/78) >.99 1.0% (1/98) 3.9% (2/51)

3.0% (6/198) 3.8% (3/78) .72 8.2% (8/98) 5.9% (3/51)

76% (151/200) 49% (39/80) <.001 55% (55/100) 62% (32/52)

5.0% (10/200) 14% (11/80) .02 19% (19/100) 3.8% (2/52)

1.5% (3/200) 16% (13/80) <.001 6.0% (6/100) 0.0% (0/52)

2.5% (5/200) 10% (8/80) .01 9.0% (9/100) 5.8% (3/52)

1.5% (3/200) 3.8% (3/80) .36 1.0% (1/100) 1.9% (1/52)

5.5% (11/200) 13% (10/80) .08 5.0% (5/100) 5.8% (3/52)

1.0% (2/200) 2.5% (2/80) .32 1.0% (1/100) 3.8% (2/52) 12% (24/200) 33% (26/80) <.001 25% (25/100) 23% (12/52)

5.2 Potential Adverse Events

Adverse events that may occur and/or require intervention include, but are not limited to:

• Amputation

• Anesthetic complications and subsequent attendant problems (e.g., aspiration)

• Aneur ysm enlargement

• Aneur ysm rupture and death

• Aor tic damage, including perforation, dissection, bleeding, rupture and death

• Ar terial or venous thrombosis and/or pseudoaneurysm

• Ar teriovenous fistula

• Bleeding, hematoma or coagulopathy

• Bowel complications (e.g., ileus, transient ischemia, infarction, necrosis)

• Cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension)

• Claudication (e.g., buttock, lower limb)

• Death

• Edema

• Embolization (micro and macro) with transient or permanent ischemia or infarction

• Endoleak

• Endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion

• Fever and localized inflammation

• Genitourinar y complications and subsequent attendant problems (e.g., ischemia, erosion, fistula, incontinence, hematuria, infection)

• Graf t or native vessel occlusion

• Hepatic failure

• Impotence

• I nfection of the aneurysm, device or access site, including abscess formation, transient fever and pain

• Lymphatic complications and subsequent attendant problems (e.g., lymph fistula)

• Neurologic local or systemic complications and subsequent attendant problems (e.g., stroke, transient ischemic attack, paraplegia, paraparesis, paralysis)

• Pulmonar y/respiratory complications and subsequent attendant problems (e.g., pneumonia, respiratory failure, prolonged intubation)

• Renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure)

• Surgical conversion to open repair

• Vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula

• Vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death)

• Vessel damage

• Wound complications and subsequent attendant problems (e.g., dehiscence, infection)

Device Related Adverse Event Reporting

Any adverse event (clinical incident) involving the Zenith Flex AAA Endovascular Graft should be reported to COOK immediately. For customers in the United States, to report an incident, call the Customer Relations Department at 1-800-457-4500 (24-hour) or 1-812-339-2235. For customers outside the United States, please call your distributor.

6 SUMMARY OF CLINICAL STUDIES

6.1 Objectives

The primary objective of the clinical study was to evaluate the safety and eﬀectiveness of a previous version of the device (Zenith AAA Endovascular Graft) as an alternative to open surgical repair in the primary treatment of infrarenal abdominal aortic aneurysms. Study hypotheses examined whether standard risk patients experienced less 30-day morbidity, non-inferior 30-day survival r ates, non-inferior 12-mon th survival rates, non-inferior 12-month treatment success and improved clinical utility measures compared to surgical control patients. Safety was determined by evaluating whether the Zenith AAA Endovascular Graft subjects would have reduced 30-day morbidity, non-inferior 30-day and 12-month survival and non-inferior 12-month treatment success compared to the subjects treated with open surgical treatment. Eﬀectiveness was based on exclusion of the aneurysm including the absence of any endoleak, the absence of aneurysm enlargement (≥5 mm) and the absence of major device adverse events evaluated through one year follow-up. Secondary objectives included an assessment of clinical beneﬁt and quality-of-life measures.

6.2 Study Design

The U.S. clinical study was a multicenter, nonrandomized study comparing standard medical risk patients who received an endovascular graft to an open surgical control. There were two additional study arms for high medical risk and roll-in treatment groups. Fifteen centers enrolled 200 standard risk, 80 surgical control, 100 high risk and 52 roll-in patients. The control group included patients whose vascular anatomy may not have been suitable for endovascular AAA repair. Follow-up evaluations were scheduled for pre-discharge, 1 month, 6 months, 12 months and 24 months. Patient followup and accountability at 1 month, 12 months and 24 months are presented in Table 6.2.1 as these were the primary data analysis time points. Imaging data provided in this summary are based on ﬁndings from an independent centralized image analysis laboratory (Core Lab) which reviewed CT scans and abdominal X-rays to assess aneurysm diameter changes, device and relative component migration, device integrity (wire and graft) and the presence and type of endoleaks. Clinical events were adjudicated by an independent clinical events committee and safety was monitored by a data safety monitoring committee.

Surgical and Zenith standard risk patients met identical pathophysiologic risk criteria. The endovascular groups excluded circumferential thrombus in the proximal neck, proximal neck less than 15 mm in length, outer wall to outer wall proximal neck diameter less than 18 mm or greater than 28 mm, severe proximal neck angulation, outer wall to outer wall iliac artery diameter less than 7.5 mm or greater than 20 mm at distal ﬁxation site or iliac artery distal ﬁxation site less than 10 mm in length.

Patients were considered at higher risk for surgical repair if they had age greater than 80, baseline creatinine >2.0 mg/dl, home oxygen therapy, FEV1 <1 liter, ejection fraction <25%, disabling COPD, New York Heart Classiﬁcation 3 or 4, hostile abdomen, dialysis, MI within last 6 months, medically intractable hypertension, previous stroke with residual deﬁcit, cultural objection to receipt of blood or blood products, previous renal bypass surgery or inﬂammatory aneurysm.

Before enrolling patients into the pivotal trial, centers without Zenith AAA Endovascular Graft experience were required to treat initial patients under the supervision of a proctor. These roll-in patients were a combination of standard and high risk patients and were followed according to the same schedule as the patients in the pivotal trial.

Table 6.2.1 Patient Follow-Up and Accountability

Treatment Zenith Standard Risk Surgical Standard Risk Interval

No device 1 Conversion to open repair 0 Expired 1 7 17 2 3 n/a

1 mo. 12 mo. 24 mo. 1 mo. 12 mo. 24 mo.

0 0 n/a

n/a n/a n/a

Withdrawn/lost to follow-up 0 0 2 0 4 n/a Available 198 190 178 78 73 n/a Site CT imaging 191 168 110 69 58 n/a Core lab CT imaging 190 165 99 69 59 n/a Site KUB imaging 179 153 108 n/a n/a n/a Core lab KUB imaging 178 149 93 n/a n/a n/a Site evaluated for endoleak 187 163 107 n/a n/a n/a Core lab evaluated for endoleak 161 148 92 n/a n/a n/a Site evaluated for aneurysm enlargement n/a 149 104 n/a n/a n/a Core lab evaluated for aneurysm enlargement n/a 151 94 n/a n/a n/a

Data analysis sample size varies for each of the time points above and in the following tables. This variability is due to patient availability for follow-up, as well as quantity and quality of images available from specific time points for evaluation. For example, the number and quality of images available for evaluation of endoleak at 12 months is different than the number and quality of images available at 24 months due to variation in the number of image exams performed, the number of images provided from the clinical site to the Core Lab and/or the number of images with acceptable evaluation quality. Totals at time points are not cumulative, unless otherwise noted.

Totals at time points are cumulative.

6.3 Patient Demographics Tables 6.3.1 and 6.3.2 compare the subject characteristics and initial aneurysm diameter of the Zenith AAA Endovascular Graft and open surgical population,

respectively.

Table 6.3.1 Comparison of Subject Characteristics

Item Zenith Standard Risk Surgical Standard Risk P value

Zenith

High Risk

Zenith Roll-in

Age (years) 71 ± 7 69 ± 7 .03 77 ± 7 74 ± 8 Gender male 94% (187/200) 89% (71/80) .22 92% (92/100) 90% (47/52)

Current medical conditions

Peripheral vascular disease Hypertension 64% (127/200) 83% (65/78) .001 68% (67/99) 67% (35/52)

16% (31/195) 25% (19/76) .12 24% (23/96) 9.6% (5/52)

Renal failure 0.0% (0/197) 0.0% (0/79) >.99 5.2% (5/97) 1.9% (1/52) COPD 20% (39/199) 18% (14/78) .87 34% (33/98) 22% (11/51) Thromboembolic event 4.5% (9/199) 7.7% (6/78) .38 7.1% (7/99) 1.9% (1/52) Liver disease 2.1% (4/192) 5.1% (4/79) .24 1.0% (1/99) 1.9% (1/52) Diabetes mellitus 12% (24/199) 15% (12/79) .55 17% (17/99) 14% (7/51) Insulin-dependent 17% (4/24) 8.3% (1/12) .65 24% (4/17) 43% (3/7)

Previous medical conditions

39% (74/192) 29% (23/80) .13 35% (34/98) 35% (18/52) Congestive heart failure 5.0% (10/199) 12% (9/78) .07 16% (16/100) 10% (5/50) Angina 49% (98/198) 39% (31/79) .14 45% (44/98) 44% (23/52) Arrhythmia 20% (40/197) 22% (17/78) .87 28% (27/98) 24% (12/51) Cerebrovascular disease 9.5% (19/199) 16% (13/79) .14 20% (20/99) 9.8% (5/51) Systemic infection 1.0% (2/196) 0.0% (0/78) >.99 3.1% (3/97) 0.0% (0/49) Cancer 22% (43/200) 19% (15/80) .74 31% (31/99) 29% (15/51)

Family history of aneurysmal disease 16% (24/150) 27% (17/63) .09 14% (11/77) 26% (10/38) Previous surgery at site 10% (20/200) 15% (12/79) .22 10% (10/99) 14% (7/51) Previous radiation at site 0.5% (1/197) 0.0% (0/79) >.99 2.0% (2/100) 2.0% (1/51) Excessive alcohol use 3.6% (7/193) 10% (8/77) .04 3.1% (3/96) 4.0% (2/50)

Tobacco use

Never smoked Past smoker 69% (133/193) 60% (48/80) .03 69% (66/96) 57% (28/49) Still smokes 21% (40/193) 35% (28/80) 18% (17/96) 18% (9/49)

Due to inclusion criteria, high risk patients were older (P<.001), had more renal failure (P=.004), COPD (P=.01), congestive heart failure (P=.004) and cerebrovascular disease (P=.02) than standard risk patients.

10% (20/193) 5.0% (4/80)

14% (13/96) 24% (12/49)

Table 6.3.2 Aneurysm Diameter Distribution

Diameter Range Zenith Standard Risk Surgical Standard Risk Zenith High Risk Zenith Roll-in <30 mm

30-39 mm 40-49 mm 50-59 mm 60-69 mm 70-79 mm 80-89 mm ≥90 mm

Aneurysm diameter distribution was not assessed in three high-risk and one roll-in patient.

0.0% (0/199) 0.0% (0/78) 0.0% (0/100) 0.0% (0/52)

0.5% (1/199) 0.0% (0/78) 1.0% (1/100) 0.0% (0/52) 23% (45/199) 7.7% (6/78) 15% (15/100) 13% (7/52) 48% (95/199) 33% (26/78) 47% (47/100) 40% (21/52) 24% (47/199) 29% (23/78) 27% (27/100) 42% (22/52)

3.0% (6/199) 21% (16/78) 5.0% (5/100) 1.9% (1/52)

2.5% (5/199) 6.4% (5/78) 1.0% (1/100) 0.0% (0/52)

0.0% (0/199) 2.6% (2/78) 1.0% (1/100) 0.0% (0/52)

6.4 Results

Data gathered in Tables 6.4.1 through 6.4.3 were collected by the clinical study sites and Core Lab. Where available, 24-month data are provided. Control patients were not followed beyond 12 months and some data have not yet been adjudicated beyond 12 months. Therefore, some results are presented to 12 months while other results are presented to 24 months in this section. Table 6.4.1 describes the devices implanted in clinical study patients. Table 6.4.2 describes the primary results from the clinical study. Figures 6.4.1 and 6.4.2 are the Kaplan-Meier plots of all-cause and AAA-related survival to 24 months, respectively. An independent clinical events committee adjudicated all deaths for possible relationship to aneurysm repair. All early deaths (0-30 days) were considered AAA-related. Deaths after 30 days were considered AAA-related if AAA disease or device involvement was confirmed. Table 6.4.3 presents Success Measures and Figure 6.4.3 is the Kaplan-Meier plot of Freedom from Morbidity.

Table 6.4.1 Devices Implanted

Item Zenith Standard Risk Zenith High Risk Zenith Roll-in

Main body and legs 99.5% (199/200)* 100% Main body extension Ipsilateral iliac leg extension Contralateral iliac leg extension Converter 0.5% (1/199)** 0.0% (0/100) 0.0% (0/52) Occluder 0.0% (0/199) 0.0% (0/100) 0.0% (0/52)

*One standard risk patient did not receive a device due to tortuosity and calcification of the access vessel. **Converter was used without occluder.

One device was custom.

Two standard risk and one high risk patient received main body extensions postprocedure; one standard risk patient received two main body extensions.

Two standard risk and one high risk patient received ipsilateral leg extensions postprocedure.

Four standard risk, two high risk and one roll-in patient received contralateral leg extensions postprocedure.

Three standard risk and three high risk patients received both ipsilateral and contralateral extensions during the procedure; one standard risk received both ipsilateral and

contralateral extensions postprocedure.

3,5

4,5

1.5% (3/199) 1.0% (1/100) 5.8% (3/52)

9.5% (19/199) 11% (11/100) 0.0% (0/52) 11% (21/199) 11% (11/100) 13.5% (7/52)

(100/100)

100% (52/52)

Table 6.4.2 Primary Results

Item Zenith Standard Risk

All death

(0-30 days)

(31-365 days) AAA-related 0.0% (0/199) 1.3% (1/80) .29 3.0% (3/100) 0.0% (0/52)

2, 3

0.5% (1/199) 2.5% (2/80) .20 2.0% (2/100) 1.9% (1/52)

3.0% (6/199) 1.3% (1/80) .68 7.0% (7/100) 9.6% (5/52)

Surgical Standard Risk P value Zenith High Risk Zenith Roll-in

Non-AAA-related 3.0% (6/199) 0.0% (0/80) .19 4.0% (4/100) 9.6% (5/52)

All death

2,3,4

(0-365 days) AAA-related 0.5% (1/199) 3.8% (3/80) .07 5.0% (5/100) 1.9% (1/52)

3.5% (7/199) 3.8% (3/80) >.99 9.0% (9/100) 11.5% (6/52)

Non-AAA-related 3.0% (6/199) 0.0% (0/80) .19 4.0% (4/100) 9.6% (5/52)

Rupture

(0-30 days) 0.0% (0/199) n/a n/a 0.0% (0/100) 0.0% (0/52) (31-365 days) 0.0% (0/199) n/a n/a 1.0% (1/100) 0.0% (0/52) (0-365 days) 0.0% (0/199) n/a n/a 1.0% (1/100) 0.0% (0/52)

Conversion

(0-30 days) 0.0% (0/199) n/a n/a 0.0% (0/100) 0.0% (0/52) (31-365 days) (0-365 days)

Adverse events

(0-30 days) (31-365 days) (0-365 days)

Denominator of 199 because one standard risk patient did not receive a device.

All deaths (0-30 days) were considered AAA and procedure related.

Of the deaths (31-365 days), four were considered AAA related: 1 surgical (septic shock from ischemic colitis) and 3 high risk (pancreatitis with renal failure and sepsis, hemorrhage

from upper abdominal aneurysm [not treated AAA] and multiple system failure).

Standard risk patients underwent conversions due to a persistent, proximal Type I endoleak and a new suprarenal aortic aneurysm. Three surgical patients had massive hemorrhages, of which 2 required re-operation and one died.

Adverse events included in the morbidity index.

1.0% (2/199) n/a n/a 1.0% (1/100) 0.0% (0/52)

20% (40/200) 43% (34/80) <.001 32% (32/100) 27% (14/52)

8.6% (17/199) 14% (11/78) .25 21% (21/98) 14% (7/51) 25% (49/200) 51% (41/80) <.001 45% (45/100) 38% (20/52)

Zenith AAA Endovascular Graft patients exhibited no significant differences between males and females for survival and freedom from major adverse events. (Error bars in Figures 6.4.1, 6.4.2 and 6.4.3 represent 95% confidence limits.) Figure 6.4.1 presents all-cause survival to 24 months. The accompanying table presents the Kaplan-Meier analysis at 1, 6, 12 and 24 months.

Figure 6.4.1 Survival at 24 Months

Zenith Standard Risk

(N=200, 1 death to 30 days 4 deaths to 6 months 7 deaths to 12 months 17 deaths to 24 months)

Surgical Standard Risk

(N=80, 2 deaths to 30 days

Percent Survival

3 deaths to 6 months 3 deaths to 12 months)

Months After Procedure

1 month 6 months 12 months 24 months

n % survival n % survival n % survival n % survival

Zenith standard

198* 99.5 194 98.0 190 96.5 97 90.9

risk

Surgical standard risk

n= Patients alive and available for follow-up at the end of the interval P = .81 *One patient expired before 1 month and one patient did not receive a device.

78 97.5 73 96.2 67 96.2 n/a n/a

Figure 6.4.2 presents AAA-related survival (determined by Clinical Events Committee) to 24 months. The accompanying table presents the KaplanMeier analysis at 1, 6, 12 and 24 months.

Figure 6.4.2 AAA-Related Survival at 24 Months

Zenith Standard Risk

(N=200, 1 death to 30 days

1 death to 6 months 1 death to 12 months 2 deaths to 24 months)

Surgical Standard Risk

Relatd Death

(N=80, 2 deaths to 30 days

3 deaths to 6 months 3 deaths to 12 months)

Percent Freedom from Aneurysm

Event: Aneurysm Related Death

Months After Procedure

1 month 6 months 12 months 24 months

n % survival n % survival n % sur vival n % survival

Zenith standard

198* 99.5 194 99.5 190 99.5 97 99.0

risk

Surgical standard risk

n= Patients alive and available for follow-up at the end of the interval P = .04 *One patient expired before 1 month and one patient did not receive a device.

78 97.5 73 96.2 67 96.2 n/a n/a

Table 6.4.3 Success Measures

Item Zenith Standard Risk Surgical Standard Risk Zenith High Risk Zenith Roll-in

Technical success

99.5% (199/200) 98.8% (79/80) 100% (100/100) 100% (52/52)

Procedural success at 30 days295.1% (155/163) 88% (60/68) 86% (70/81) 91% (30/33)

Treatment success at

12 months

Patent graft following deployment.

Technical success with no major complications, patent graft and no Type I or Type III endoleaks at 30 days.

Procedural success extended to 12 months with no aneurysm enlargement (>5 mm).

Figure 6.4.3 presents freedom from morbidity (events in the morbidity index) to 12 months. The accompanying table presents the Kaplan-Meier analysis at 1, 6 and 12 months.

89% (122/137) 85% (52/61) 70% (44/63) 87% (26/30)

Figure 6.4.3 Freedom from Morbidity (0-365 days)

Zenith Standard Risk

(N=200, 38 patients with events to 30 days

43 patients with events to 6 months 45 patients with events to 12 months)

Surgical Standard Risk

(N=80, 34 patients with events to 30 days

38 patients with events to 6 months

Percent Freedom from Morbidity

41 patients with events to 12 months)

Months After Procedure

1 month 6 months 12 months

n % n % n %

Zenith standard risk 162 81.0 154 78.5 133 77.4 Surgical standard risk 45 57.1 39 52.0 33 47.8

n= Patients alive and free of morbidity at the end of the interval P = <.001

Tables 6.4.4 through 6.4.7 describe results of the Zenith AAA Endovascular Graft subjects as reported by the Core Lab. Device performance factors analyzed by the Core Lab include device integrity (Table 6.4.4), device patency (Table 6.4.5), migration (Table 6.4.6) and limb separation (Table 6.4.7).

Table 6.4.4 Abdominal Radiographic Findings – Device Integrity

Item Zenith Standard Risk Zenith High Risk Zenith Roll-in

Stent Fractures

Pre-discharge 0.0% (0/172) 0.0% (0/81) 0.0% (0/39) 30 day 0.0% (0/172) 0.0% (0/83) 0.0% (0/43) 6 month 0.0% (0/166) 0.0% (0/78) 0.0% (0/35) 12 month 0.0% (0/148) 0.0% (0/60) 0.0% (0/28) 24 month 0.0% (0/93) 0.0% (0/42) 0.0% (0/19)

Barb Separation

Pre-discharge 0.0% (0/176) 0.0% (0/86) 0.0% (0/39) 30 day 0.0% (0/178) 0.0% (0/86) 0.0% (0/43) 6 month 1.2% (2/167) 2.5% (2/80) 0.0% (0/35) 12 month 2.0% (3/149) 1.7% (1/60) 0.0% (0/28) 24 month 1.1% (1/93) 0.0% (0/42) 0.0% (0/19)

Graft material rupture

Pre-discharge 0.0% (0/176) 0.0% (0/86) 0.0% (0/39) 30 day 0.0% (0/178) 0.0% (0/86) 0.0% (0/43) 6 month 0.0% (0/167) 0.0% (0/80) 0.0% (0/35) 12 month 0.0% (0/149) 0.0% (0/60) 0.0% (0/28) 24 month 0.0% (0/93) 0.0% (0/42) 0.0% (0/19)

Stent fracture percentages are for main body. There were also no right iliac leg, left iliac leg, occluder, converter, left iliac extension, right iliac extension or main body extension fractures observed by the Core Lab.

Patients with separation of 1 or 2 barbs (of 10 or 12 total); no adverse clinical sequelae.

Table 6.4.5 CT Findings – Graft Patency

Item Zenith Standard Risk Zenith High Risk Zenith Roll-in

Graft patency

30 day 100% (185/185) 99% (85/86) 100% (47/47) 6 month 99% (183/184) 100% (74/74) 100% (39/39) 12 month 99% (153/155) 100% (62/62) 100% (30/30) 24 month 100% (96/96) 100% (33/33) 100% (25/25)

Table 6.4.6 CT Findings – Graft (Main Body) Migration

Item Zenith Standard Risk Zenith High Risk Zenith Roll-in

Graft migration (>5 mm) at 12 months

with clinical sequelae1 or intervention 0.0% (0/162) 0.0% (0/71) 0.0% (0/34) without clinical sequelae1 or intervention 2.5% (4/162) 2.8% (2/71) 0.0% (0/34)

Graft migration (>10 mm) 0.0% (0/162) 0.0% (0/71) 0.0% (0/34)

Migration with clinical sequelae would include endoleak, conversion, rupture or AAA-related death.

Table 6.4.7 Abdominal Radiograph Findings – Limb Separation

Item Zenith Standard Risk Zenith High Risk Zenith Roll-in

Limb separation

6.5 Endoleak Management

During the clinical study Type I endoleaks were treated during the initial procedure by use of additional balloon seating or, if unsuccessful, additional prostheses. Type II endoleaks were observed for a period of one to six months to determine if they would spontaneously thrombose, or in the absence of enlarging aneurysms, they were treated with endovascular techniques at the discretion of the practicing physician. If the aneurysm enlarged, treatment by embolization or ligation was considered and, in some cases, performed. Type III endoleaks caused by graft defects, inadequate seal or disconnection of the modular components were treated with additional ballooning or prostheses. As reported by the angiographic Core Lab, there were no Type IV endoleaks during the U.S. clinical study. The graft material used to manufacture the Zenith AAA Endovascular Graft is of standard thickness and is the same material used in open surgical procedures. Table 6.5.1 presents the incidence of endoleaks by evaluation interval, as identified by the Core Lab for the standard risk, high risk and roll-in patients, respectively.

Table 6.5.1 Endoleaks (All Types, New and Persistent)

Item Zenith Standard Risk Zenith High Risk Zenith Roll-in

Endoleaks

Pre-discharge 15% (23/153) 14% (11/78) 12% (3/26)

30-day

6-month

12-month

Includes both persistent endoleaks and new observations.

Tables 6.5.2 – 6.5.4 present the incidence of first occurrence of an endoleak according to evaluation interval, as identified by the Core Lab at or before the 30-day, 6-month and 12-month exams for the standard risk, high risk and roll-in patients, respectively. The number of patients who are leak-free thereafter is also given.

9.9% (16/161) 12% (9/75) 6.3% (2/32)

8.7% (15/172) 11% (8/70) 8.6% (3/35)

7.4% (11/148) 8.8% (5/57) 3.4% (1/29)

Table 6.5.2 First Occurrence of Endoleak1 for Standard Risk Patients

Item

To One-Month Exam

N=179

% Endoleak

Leak-free

Thereafter

Six-Month Exam

N=172

% Endoleak

Leak-free

Thereafter

Twelve-Month Exam

N=148

% Endoleak

Leak-free

Thereafter

Endoleaks 17 31 17 2.3 4 3 3.4 5 2

Proximal Type I 2.8 5 4 0.0 0 0 0.0 0 0 Distal

Type I 1.7 3 1 0.0 0 0 0.7 1 1 Type II 9.5 17 9 2.3 4 3 1.4 2 1 Type III 1.1 2 2 0.0 0 0 0.7 1 0

Type IV 0.0 0 0 0.0 0 0 0.0 0 0 Multiple 1.1 2 1 0.0 0 0 0.0 0 0 Unknown 1.1 2 0 0.0 0 0 0.7 1 0

Identified by Core Lab.

Subsequent endoleaks may have been of different type than original.

Only 2 patients had new endoleaks after 12 months; follow-up after 24 months not available.

Table 6.5.3 First Occurrence of Endoleak1 for High Risk Patients

Item

To One-Month Exam

N=88

% Endoleak

Leak-free

Thereafter

Six-Month Exam

N=70

% Endoleak

Leak-free

Thereafter

Twelve-Month Exam3

N=57

% Endoleak

Thereafter

Endoleaks 18 16 6 2.9 2 0 3.5 2 1

Proximal Type I 2.3 2 1 0.0 0 0 0.0 0 0 Distal

Type I 1.1 1 1 0.0 0 0 0.0 0 0

Type II 9.1 8 3 1.4 1 0 1.8 1 0

Type III 0.0 0 0 1.4 1 0 1.8 1 1

Type IV 0.0 0 0 0.0 0 0 0.0 0 0 Multiple 4.5 4 0 0.0 0 0 0.0 0 0 Unknown 1.1 1 1 0.0 0 0 0.0 0 0

Identified by Core Lab.

Subsequent endoleaks may have been of different type than original.

No endoleaks after 12 months; follow-up after 24 months not available.

Leak-free

Table 6.5.4 First Occurrence of Endoleak1 for Roll-in Patients

Item

To One-Month Exam

N=36

% Endoleak

Leak-free

Thereafter

Six-Month Exam

N=35

% Endoleak

Leak-free

Thereafter

Twelve-Month Exam3

N=29

% Endoleak

Thereafter

Endoleaks 11 4 2 2.9 1 0 0.0 0 0

Proximal Type I 0.0 0 0 0.0 0 0 0.0 0 0 Distal

Type I 0.0 0 0 0.0 0 0 0.0 0 0

Type II 5.6 2 1 2.9 1 0 0.0 0 0

Type III 2.8 1 0 0.0 0 0 0.0 0 0

Type IV 0.0 0 0 0.0 0 0 0.0 0 0 Multiple 0.0 0 0 0.0 0 0 0.0 0 0 Unknown 2.8 1 1 0.0 0 0 0.0 0 0

Identified by Core Lab.

Subsequent endoleaks may have been of different type than original.

No endoleaks after 12 months; follow-up after 24 months not available.

Leak-free

6.6 Aneurysm Change Tables 6.6.1 - 6.6.3 present the change in aneurysm diameter for the endovascular patients, as identified by the Core Lab. Table 6.6.1 presents maximum

aneurysm diameter change by interval. Tables 6.6.2 and 6.6.3 present aneurysm change and endoleak at 12 and 24 months, respectively.

Table 6.6.1 Change in Maximum Aneurysm Diameter by Interval*

Item Zenith Standard Risk Zenith High Risk Zenith Roll-in

From pre-discharge 30-day

Decrease >5 mm 1.7% (3/180) 4.8% (4/84) 0.0% (0/40) Unchanged 97% (174/180) 94% (79/84) 97.5% (39/40) Increase >5 mm 1.7% (3/180) 1.2% (1/84) 2.5% (1/40)

Change from pre-discharge 6-month

Decrease >5 mm 36% (63/173) 41% (30/73) 49% (18/37) Unchanged 62% (108/173) 59% (43/73) 51% (19/37) Increase >5 mm 1.2% (2/173) 0.0% (0/73) 0.0% (0/37)

Change from pre-discharge 12-month

Decrease >5 mm 68% (102/151) 63% (39/62) 67% (20/30) Unchanged 31% (47/151) 35% (22/62) 33% (10/30) Increase >5 mm 1.3% (2/151) 1.6% (1/62) 0.0% (0/30)

Change from pre-discharge 24-month

Decrease >5 mm 78% (74/94) 75% (27/36) 71% (17/24) Unchanged 19% (18/94) 25% (9/36) 25% (6/24) Increase >5 mm 2.1% (2/94) 0.0% (0/36) 4.2% (1/24)

*Only includes subjects with interpretable films and measurements of aneurysm change from 1 to 24 months.

Table 6.6.2 Change in Aneurysm Size and Endoleak at 12 Months

Zenith Standard Risk

N=140

Zenith High Risk

N=53

Zenith Roll-in

N=27

Endoleak Endoleak Endoleak

Item

Aneurysm size change from pre-discharge to 12 months

N n % N n % N n %

Decrease >5 mm 96 3 3.0 35 3 9.0 20 0 0.0 Unchanged 42 8 19 17 2 12 7 1 14 Increase >5 mm 2 0 0.0 1 0 0.0 0 0 0.0

Table 6.6.3 Change in Aneurysm Size and Endoleak at 24 Months

Zenith Standard Risk

N=90

Zenith High Risk

N=31

Zenith Roll-in

N=21

Endoleak Endoleak Endoleak

Item

Aneurysm size change from pre-discharge to 24 months

N n % N n % N n %

Decrease >5 mm 71 3 4.0 24 1 4.0 16 0 0.0 Unchanged 18 1 6.0 7 3 43 5 0 0.0 Increase >5 mm 1 1 100 1 0 0.0 0 0 0.0

6.7 AAA-Related Secondary Interventions

AAA-related secondary interventions within the first year were performed in 11% of the Zenith standard risk, 13% Zenith high risk and 5.8% Zenith roll-in subjects as shown in Table 6.7.1. Greater than 50% of the secondary interventions involved catheterization to treat an endoleak. AAA-related secondary interventions within the second year were performed in 4.2% of the Zenith standard risk, 2.2% Zenith high risk and 2.3% Zenith roll-in subjects as shown in

Table 6.7.2.

Table 6.7.1 Secondary Interventions (to 12 Months)

Intervention

Conversion to open repair 2 1.0 1 1.0 0 0.0

Zenith Standard Risk

N=199

Zenith High Risk

N=100

Zenith Roll-in

N=52

n % n % n %

Subjects with ≥1 intervention 21 11 13 13 3 5.8 Treat an endoleak

Embolization 5 2.5 3 3.0 1 2.0 Ancillary component 6 3.0 4 4.0 1 2.0 Stent 1 0.5 0 0.0 0 0.0 Angioplasty 0 0.0 1 1.0 0 0.0

Treat an aneurysm increase

Embolization 0 0.0 0 0.0 0 0.0

Treat a limb occlusion 1 0.5 3 3.0 1 2.0 Treat a limb stenosis 1 0.5 0 0.0 0 0.0 Treat a renal artery 5 2.5 0 0.0 0 0.0 Treat infra-inguinal ischemia 1 0.5 1 1.0 0 0.0 Treat multiple events 1 0.5 1 1.0 0 0.0

Table 6.7.2 Secondary Interventions (>12 to 24 Months)

Intervention

Conversion to open repair 1 0.5 1 1.1 0 0.0

Zenith Standard Risk

N=190

Zenith High Risk

N=90

Zenith Roll-in

N=44

n % n % n %

Subjects with ≥1 intervention 8 4.2 2 2.2 1 2.3 Treat an endoleak

Embolization Ancillary component 1 0.5 0 0.0 0 0.0

1.6 0 0.0

Stent 0 0.0 1 1.1 0 0.0 Angioplasty 0 0.0 0 0.0 0 0.0

Treat an aneurysm increase

Embolization 1 0.5 0 0.0

Treat a limb occlusion 1 0.5 0 0.0 0 0.0

Treat a limb stenosis 0 0.0 0 0.0 0 0.0 Treat a renal artery 0 0.0 1 1.1 0 0.0 Treat infra-inguinal ischemia 1 0.5 0 0.0 0 0.0 Treat multiple events 1 0.5 0 0.0 0 0.0

Patient also received ancillary component.

Patient underwent intervention to treat aneurysm increase and endoleak.

2.3

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