Medtronic 700FC33 Instructions for Use

Simulus™

Flexible Annuloplasty Ring/Band • Anneau/Bande pour annuloplastie flexibles • Flexibler Annuloplastie-Ring/flexibles Annuloplastie-Band • Anillo/banda flexible para anuloplastia • Anello/emianello flessibile per anuloplastica • Flexibele annuloplastiekring/-band • Flexibel anuloplastikring/-band • Fleksibel annuloplastikring/-bånd • Fleksibel annuloplastikkring/-bånd • Anel/banda de anuloplastia flexível • Εύκαμπτος δακτύλιος δακτυλιοπλαστικής/Εύκαμπτος ανοικτός δακτύλιος δακτυλιοπλαστικής • Flexibilní anuloplastický prstenec/proužek • Elastyczny pierścień zamknięty/pierścień otwarty do annuloplastyki • Rugalmas anuloplasztikai gyűrű/pánt • Esnek Anüloplasti Halkası/Bandı • Flexibilný anuloplastický prstenec/pásik

700FF, 700FC, 725FC

Instructions for Use • Mode d’emploi • Gebrauchsanweisung • Instrucciones de uso • Istruzioni per l’uso • Gebruiksaanwijzing • Bruksanvisning • Brugsanvisning • Bruksanvisning • Instruções de utilização • Οδηγίες χρήσης • Návod k použití • Instrukcja użytkowania • Használati útmutató • Kullanım Talimatları • Pokyny na používanie

Caution: Federal law (USA) restricts

this device to sale by or on the order of a physician.

Trademarks may be registered and are the property of their respective owners. Les marques commerciales mentionnées peuvent être déposées et appartiennent à leurs propriétaires respectifs. Marken sind eventuell eingetragen und sind das Eigentum ihrer jeweiligen Inhaber. Las marcas comerciales pueden estar registradas y pertenecen a sus respectivos propietarios. I marchi di fabbrica possono essere registrati e sono di proprietà dei rispettivi titolari. Handelsmerken kunnen zijn geregistreerd en zijn het eigendom van de desbetreffende eigenaren. Varumärken kan vara registrerade och tillhör respektive ägare. Varemærker kan være registrerede og tilhører deres respektive ejere. Varemerkene kan være registrert og tilhører de respektive eierne. As marcas comerciais podem ser registadas e são propriedade dos respetivos detentores. Τα εμπορικά σήματα μπορεί να είναι καταχωρημένα και είναι ιδιοκτησία των αντίστοιχων κατόχων τους. Ochranné známky (mohou být registrované) jsou majetkem příslušných vlastníků. Znaki towarowe mogą być zastrzeżone i są własnością odpowiednich podmiotów. A védjegyek bejegyzettek lehetnek, és a megfelelő védjegytulajdonosok tulajdonát képezik. Ticari markalar tescilli olabilir ve ilgili sahiplerinin mülkiyetindedir. Ochranné známky môžu byť registrované a sú majetkom ich príslušných vlastníkov.

Explanation of symbols on package labeling / Explication des symboles des étiquettes sur l’emballage / Erläuterung der Symbole auf der Verpackung / Explicación de los símbolos que aparecen en la documentación del envase / Spiegazione dei simboli sulle etichette della confezione / Verklaring van de symbolen op de verpakkingslabels / Förklaring av symboler på förpackningsetiketten och i övrig förpackningsdokumentation / Forklaring af symbolerne på emballagens mærkater / Forklaring av symboler på pakningen / Explicação dos símbolos na documentação da embalagem / Επεξήγηση των συμβόλων στη σήμανση της συσκευασίας / Vysvětlení symbolů uvedených na štítcích balení / Objaśnienie symboli znajdujących się na etykietach opakowania / A csomagoláson látható szimbólumok jelentése / Ambalaj etiketlerindeki ve belgelerindeki sembollerin açıklaması / Vysvetlivky k symbolom na označení balenia

Refer to the outer package label to see which symbols apply to this product / Se référer à l'étiquette sur l'emballage extérieur pour savoir quels symboles s'appliquent à ce produit / Welche Symbole für dieses Produkt zutreffen, entnehmen Sie bitte dem Etikett auf der Verpackung. / Consulte la etiqueta del envase exterior para comprobar qué símbolos son aplicables a este producto / Fare riferimento all'etichetta sulla confezione esterna per sapere quali simboli si applicano a questo prodotto / Controleer het label op de buitenverpakking om te zien welke symbolen op dit product van toepassing zijn / Se etiketten på ytterförpackningen för vilka symboler som gäller denna produkt / Se mærkaten på den ydre emballage for de symboler, der gælder for dette produkt / Se på etiketten utenpå pakningen for å fastslå hvilke symboler som gjelder for dette produktet / Consultar a etiqueta exterior da embalagem para ver que símbolos se aplicam a este produto / Ανατρέξτε στην ετικέτα της εξωτερικής συσκευασίας για να δείτε ποια σύμβολα ισχύουν για το παρόν προϊόν / Symboly, které se vztahují k tomuto výrobku, naleznete na štítku na vnější straně obalu. / Należy zapoznać się z etykietą na zewnętrznym opakowaniu, aby określić, które symbole dotyczą niniejszego produktu / A termékre vonatkozó szimbólumok a külső csomagoláson találhatók. / Bu üründe hangi sembollerin geçerli olduğunu görmek için

dış ambalaj etiketine başvurun / Prezrite si označenie na vonkajšom obale a zistite, ktoré symboly sa vzťahujú na tento výrobok

Conformité Européenne (European Conformity). This symbol means that the device fully complies with applicable European Union Acts. / Conformité Européenne. Ce symbole signifie que l'appareil est entièrement conforme aux lois en vigueur de l'Union européenne. / Conformité Européenne (Europäische Konformität). Dieses Symbol besagt, dass das Gerät alle Vorschriften der einschlägigen EUGesetzgebung erfüllt. / Conformité Européenne (Conformidad Europea). Este símbolo indica que el dispositivo cumple totalmente las Directivas europeas pertinentes. / Conformité Européenne (Conformità europea). Questo simbolo indica che il dispositivo è pienamente conforme alle direttive europee in vigore. / Conformité Européenne (Europese conformiteit). Dit symbool betekent dat het product volledig voldoet aan de geldende Europese wetgeving. / Conformité Européenne (Europeisk standard). Denna symbol anger att enheten uppfyller alla gällande lagar i den Europeiska unionen. / Conformité Européenne (Europæisk Standard). Dette symbol betyder, at enheden fuldt ud overholder gældende EUlovgivning. / Conformité Européenne (samsvar med europeisk standard). Dette symbolet betyr at enheten er fullstendig i samsvar med gjeldende EU-rettsakter. / Conformité Européenne (Conformidade Europeia). Este símbolo significa que o dispositivo está em total conformidade com os Atos da União Europeia aplicáveis. / Conformité Européenne (Ευρωπαϊκή Συμμόρφωση). Το σύμβολο αυτό σημαίνει ότι το προϊόν συμμορφώνεται πλήρως με τους ισχύοντες νόμους της Ευρωπαϊκής Ένωσης. / Conformité Européenne (Evropská shoda). Tento symbol znamená, že zařízení zcela splňuje požadavky příslušných zákonů Evropské unie. / Conformité Européenne (zgodność z normami Unii Europejskiej). Ten

symbol oznacza, że urządzenie spełnia wszystkie wymogi wynikające z właściwych aktów prawnych Unii Europejskiej. / Conformité Européenne (Európai Megfelelőség). Ez a szimbólum azt jelenti, hogy az eszköz teljes mértékben megfelel az Európai Unió vonatkozó jogszabályainak. / Conformité Européenne (Avrupa Normlarına Uygunluk). Bu sembol, cihazın yürürlükteki Avrupa Birliği Yasalarına tam olarak uygun olduğunu ifade eder. / Conformité Européenne (Zhoda s požiadavkami EÚ). Tento symbol znamená, že zariadenie je v úplnom súlade s platnými právnymi predpismi Európskej únie.

Nonpyrogenic / Apyrogène / Pyrogenfrei / Apirógeno / Apirogeno / Niet-pyrogeen / Ickepyrogen / Ikke-pyrogen / Pyrogenfri / Apirogénico / Μη πυρετογόνο / Nepyrogenní / Produkt niepirogenny / Nem pirogén / Pirojenik Değildir / Nepyrogénne

Sterilized Using Irradiation / Stérilisation par irradiation / Mit Strahlung sterilisiert / Esterilizado mediante irradiación / Sterilizzato con radiazioni ionizzanti / Gesteriliseerd met straling / Steriliserad med strålning / Steriliseret med stråling / Sterilisert med stråling / Esterilizado por irradiação / Αποστειρωμένο με ακτινοβολία / Sterilizováno zářením / Produkt sterylizowany metodą radiacyjną / Sugárzással sterilizálva / İrradyasyonla Sterilize Edilmiştir / Sterilizované žiarením

Inner Diameter / Diamètre interne / Innendurchmesser / Diámetro interno / Diametro interno / Binnendiameter / Innerdiameter / Indvendig diameter / Indre diameter / Diâmetro interno / Εσωτερική διάμετρος / Vnitřní průměr / Średnica wewnętrzna / Belső átmérő / İç Çap / Vnútorný priemer

Do Not Reuse / Ne pas réutiliser / Nicht wiederverwenden / No reutilizar / Non riutilizzare / Niet opnieuw gebruiken / Får inte återanvändas / Må ikke genbruges / Skal ikke brukes flere ganger / Não reutilizar / Μην επαναχρησιμοποιείτε / Nepoužívejte opakovaně / Produkt do jednorazowego zastosowania / Kizárólag egyszeri használatra / Yeniden Kullanmayın / Nepoužívajte opakovane

Do Not Resterilize / Ne pas restériliser / Nicht resterilisieren / No reesterilizar / Non risterilizzare / Niet hersteriliseren / Får inte omsteriliseras / Må ikke resteriliseres / Skal ikke resteriliseres / Não reesterilizar / Μην επαναποστειρώνετε / Neprovádějte resterilizaci / Nie sterylizować ponownie / Nem újrasterilizálható / Yeniden Sterilize Etmeyin / Opakovane nesterilizujte

Use By / À utiliser jusqu'au / Zu verwenden bis einschließlich / No utilizar después de / Utilizzare entro / Uiterste gebruiksdatum / Får användas till och med / Kan anvendes til og med / Siste forbruksdag / Não utilizar depois de / Χρήση έως / Datum použitelnosti / Termin ważności / Lejárat / Son Kullanma Tarihi / Dátum najneskoršej spotreby

Lot Number / Numéro de lot / Chargennummer / Número de lote / Numero di lotto / Partijnummer / Lotnummer / Partinummer / Lotnummer / Número de lote / Αριθμός παρτίδας / Číslo šarže / Numer partii / Gyártási szám / Lot Numarası / Číslo šarže

Quantity / Quantité / Menge / Cantidad / Quantità / Aantal / Antal / Antal / Antall / Quantidade / Ποσότητα / Množství / Ilość / Mennyiség / Miktar / Množstvo

Consult Instructions for Use / Consulter le mode d'emploi / Gebrauchsanweisung beachten / Consultar las instrucciones de uso / Consultare le istruzioni per l'uso / Raadpleeg gebruiksaanwijzing / Läs bruksanvisningen / Se brugsanvisningen / Se i bruksanvisningen / Consultar instruções de utilização / Συμβουλευτείτε τις Οδηγίες χρήσης / Viz návod k použití / Należy zapoznać się z instrukcją użytkowania / Lásd a használati útmutatót / Kullanım Talimatlarına Bakın / Pozrite návod na použitie

For US Audiences Only / Uniquement pour les États-Unis / Gilt nur für Leser in den USA / Sólo aplicable en EE. UU. / Esclusivamente per il mercato statunitense / Alleen van toepassing voor de VS / Gäller endast i USA / Gælder kun i USA / Gjelder bare USA / Apenas aplicável aos EUA / Μόνο για πελάτες εντός των ΗΠΑ / Pouze pro uživatele z USA / Dotyczy tylko klientów w USA / Csak egyesült államokbeli felhasználóknak / Sadece ABD'deki Kullanıcılar İçin / Len pre používateľov v USA

Keep Dry / À conserver dans un endroit sec / Trocken aufbewahren / Mantener seco / Mantenere asciutto / Droog bewaren / Förvaras torrt / Skal opbevares tørt / Skal holdes tørr / Manter seco / Διατηρήστε στεγνό / Udržujte v suchu / Chronić przed wilgocią / Szárazon tartandó / Kuru Olarak Saklayın / Uchovávajte v suchu

Date of Manufacture / Date de fabrication / Herstellungsdatum / Fecha de fabricación / Data di fabbricazione / Productiedatum / Tillverkningsdatum / Fremstillingsdato / Produksjonsdato / Data de fabrico / Ημερομηνία κατασκευής / Datum výroby / Data produkcji / A gyártás ideje / İmalat Tarihi / Dátum výroby

Serial Number / Numéro de série / Seriennummer / Número de serie / Numero di serie / Serienummer / Serienummer / Serienummer / Serienummer / Número de série / Αριθμός σειράς / Sériové číslo / Numer seryjny / Sorozatszám / Seri Numarası / Sériové číslo

Catalog Number / Numéro de référence / Katalognummer / Número de catálogo / Numero di catalogo / Catalogusnummer / Katalognummer / Katalognummer / Artikkelnummer / Número de catálogo / Αριθμός καταλόγου / Katalogové číslo / Numer katalogowy / Katalógusszám / Katalog Numarası / Katalógové číslo

Manufacturer / Fabricant / Hersteller / Fabricante / Fabbricante / Fabrikant / Tillverkare / Fabrikant / Produsent / Fabricante / Κατασκευαστής / Výrobce / Producent / Gyártó / İmalatçı / Výrobca

Authorized Representative in the European Community / Représentant agréé dans la Communauté européenne / Autorisierter Repräsentant in der Europäischen Gemeinschaft / Representante autorizado en la Comunidad Europea / Rappresentante autorizzato nella Comunità europea / Geautoriseerd vertegenwoordiger in de Europese Gemeenschap / Auktoriserad representant inom EG / Autoriseret repræsentant i Det Europæiske Fællesskab / Autorisert representant i Det europeiske fellesskap / Representante autorizado na Comunidade Europeia / Εξουσιοδοτημένος αντιπρόσωπος στην Ευρωπαϊκή Κοινότητα / Autorizovaný zástupce pro Evropské společenství / Autoryzowany przedstawiciel we Wspólnocie Europejskiej / Hivatalos képviselet az Európai Közösségben / Avrupa Topluluğu'ndaki Yetkili Temsilci / Autorizovaný zástupca pre Európske spoločenstvo

Do Not Use if Package is Damaged / Ne pas utiliser si l'emballage est endommagé / Nicht verwenden, wenn die Verpackung beschädigt ist / No utilizar si el envase está dañado / Non utilizzare se l'imballaggio non è integro / Niet gebruiken als de verpakking beschadigd is / Får inte användas om förpackningen är skadad / Må ikke anvendes, hvis emballagen er beskadiget / Skal ikke brukes hvis pakningen er skadet / Não utilizar se a embalagem estiver danificada / Μην το χρησιμοποιείτε αν η συσκευασία έχει υποστεί ζημιά / Nepoužívejte, je-li balení poškozeno / Nie stosować, jeśli opakowanie jest uszkodzone / Ne használja fel, ha a csomagolás sérült / Ambalaj Hasarlıysa Kullanmayın / Nepoužívajte, ak je obal poškodený

Manufactured In / Fabriqué à / Hergestellt in / Fabricado en / Prodotto in / Vervaardigd in / Tillverkad i / Fremstillet i / Produsert i / Fabricado em / Κατασκευάστηκε σε / Vyrobeno v / Miejsce produkcji / A gyártás helye / İmalat Yeri / Vyrobené v

MR Safe / RM sans risque / MR-sicher / Seguro para RM / Dispositivo sicuro per la risonanza magnetica (RM) / MR Safe (MR-veilig) / MRsäker / MR-scanningssikker / MR-sikker / RM seguro / Ασφαλές για μαγνητική τομογραφία (MR) / Bezpečné z hlediska magnetické rezonance / Bezpieczny w zastosowaniu z rezonansem magnetycznym / MR szempontjából biztonságos / MR Güvenli / Bezpečné v prostredí MR

Figure 1. Ring / Figure 1. Anneau / Abbildung 1. Ring / Figura 1. Anillo /

Figura 1. Anello / Afbeelding 1. Ring / Figur 1. Ring / Figur 1. Ring /

Figur 1. Ring / Figura 1. Anel / Εικόνα 1. Δακτύλιος /

Obrázek 1. Prstenec / Rycina 1. Pierścień zamknięty / 1. ábra. Gyűrű /

Şekil 1. Halka / Obrázok 1. Prstenec

1. Mitral trigone/tricuspid commissure markers / Marqueurs des commissures de la valve tricuspide/des trigones de la valve mitrale / Markierungen für die Mitralklappentrigona/ Trikuspidalklappenkommissuren / Marcas de los trígonos (válvula mitral)/de las comisuras (válvula tricúspide) / Marcatori dei trigoni (valvola mitrale)/delle commissure (valvola tricuspide) / Mitrale trigonummarkering/tricuspidale commissuurmarkering / Markörer för mitraltrigoner/trikuspidalkommissurer / Markører for mitral trigonum/trikuspidal kommissur / Trigonmarkør (mitral) / kommissurmarkør (tricuspidal) / Marcadores dos trígonos mitrais/comissuras tricúspides / Δείκτες μιτροειδούς τριγώνου/συνδέσμων τριγλώχινος / Značky pro mitrální trigonum/trikuspidální komisuru / Znaczniki trójkątów włóknistych zastawki mitralnej/spoideł zastawki trójdzielnej / Mitrális trigonum-/tricuspidális commissurajelölések / Mitral trigon/triküspid

komisür belirteçleri / Značky mitrálneho

trigona/trikuspidálnej komisúry

2. Midpoint marker / Marqueur de milieu / Mittelpunktsmarkierung / Marca del punto medio / Marcatore del punto medio / Middelpuntmarkering / Mittpunktsmarkör / Midtpunktsmarkør / Midtpunktmarkør / Marcador do ponto central / Δείκτης μέσου σημείου / Značka určující střed / Znacznik środkowy / Középső jelölés / Orta nokta belirteci / Značka označujúca stred

Figure 2. Band / Figure 2. Bande / Abbildung 2. Band /

Figura 2. Banda / Figura 2. Emianello / Afbeelding 2. Band /

Figur 2. Band / Figur 2. Bånd / Figur 2. Bånd / Figura 2. Banda /

Εικόνα 2. Ανοικτός δακτύλιος / Obrázek 2. Proužek /

Rycina 2. Pierścień otwarty / 2. ábra. Pánt / Şekil 2. Bant /

Obrázok 2. Pásik

Mitrale trigonummarkering/tricuspidale commissuurmarkering / Markörer för mitraltrigoner/trikuspidalkommissurer / Markører for mitral trigonum/trikuspidal kommissur / Trigonmarkør (mitral) / kommissurmarkør (tricuspidal) / Marcadores dos trígonos mitrais/comissuras tricúspides / Δείκτες μιτροειδούς τριγώνου/συνδέσμων τριγλώχινος / Značky pro mitrální trigonum/trikuspidální komisuru / Znaczniki trójkątów włóknistych zastawki mitralnej/spoideł zastawki trójdzielnej / Mitrális trigonum-/tricuspidális commissurajelölések / Mitral trigon/triküspid komisür belirteçleri / Značky mitrálneho trigona/trikuspidálnej komisúry

Figure 3 / Figure 3 / Abbildung 3 / Figura 3 / Figura 3 / Afbeelding 3 /

Figur 3 / Figur 3 / Figur 3 / Figura 3 / Εικόνα 3 / Obrázek 3 / Rycina 3 /

3. ábra / Şekil 3 / Obrázok 3

1. Handle / Manche / Handgriff / Asa / Impugnatura / Handgreep / Handtag / Håndtag / Håndtak / Manípulo / Λαβή / Rukojeť / Uchwyt / Fogantyú / Kol / Rukoväť

2. Ring holder / Support de l'anneau / Ringhalter / Soporte del anillo / Supporto dell'anello /

Ringhouder / Ringhållare / Ringholder / Ringholder / Suporte do anel / Υποδοχή δακτυλίου / Držák prstence / Uchwyt pierścienia zamkniętego / Gyűrűtartó / Halka tutucusu / Držiak prstenca

3. Band holder / Support de la bande / Bandhalter / Soporte de la banda / Supporto dell'emianello / Bandhouder / Bandhållare / Båndholder / Båndholder / Suporte da banda / Υποδοχή ανοικτού δακτυλίου / Držák proužku / Uchwyt pierścienia otwartego / Pánttartó / Bant tutucusu / Držiak pásika

4. Ring / Anneau / Ring / Anillo / Anello / Ring / Ring / Ring / Ring / Anel / Δακτύλιος / Prstenec / Pierścień zamknięty / Gyűrű / Halka / Prstenec

5. Band / Bande / Band / Banda / Emianello / Band / Band / Bånd / Bånd / Banda / Ανοικτός δακτύλιος / Proužek / Pierścień otwarty / Pánt / Bant / Pásik

Figure 4. Sizing the mitral annulus / Figure 4. Calibrage de l'anneau mitral / Abbildung 4. Größenbestimmung des Mitralklappen-Anulus /

Figura 4. Medición del anillo mitral / Figura 4. Determinazione della

dimensione dell'annulus mitrale / Afbeelding 4. Meten van de annulus

van de mitralisklep / Figur 4. Mätning av mitralklaffens anulus /

Figur 4. Måling af den mitrale annulus / Figur 4. Måle mitralannulus /

Figura 4. Dimensionamento do anel mitral / Εικόνα 4. Προσδιορισμός

μεγέθους του δακτυλίου μιτροειδούς / Obrázek 4. Určení velikosti

mitrálního anulu / Rycina 4. Pomiar pierścienia mitralnego /

4. ábra. Mitrális anulus méretvétele / Şekil 4. Mitral anülus boyutunun belirlenmesi / Obrázok 4. Určenie veľkosti mitrálneho anulu

Figure 5. Sizing the tricuspid annulus / Figure 5. Calibrage de l'anneau

tricuspide / Abbildung 5. Größenbestimmung des Trikuspidalklappen-

Figura 5. Determinazione della dimensione dell'annulus tricuspidale /

Figur 5. Mätning av trikuspidalklaffens anulus / Figur 5. Måling af den

Şekil 5. Triküspid anülus boyutunun belirlenmesi / Obrázok 5. Určenie

Anulus / Figura 5. Medición del anillo tricuspídeo /

Afbeelding 5. Meten van de annulus van de tricuspidalisklep /

trikuspidale annulus / Figur 5. Måle tricuspidalannulus /

Figura 5. Dimensionamento do anel tricúspide /

Εικόνα 5. Προσδιορισμός μεγέθους του δακτυλίου τριγλώχινας /

Obrázek 5. Určení velikosti trikuspidálního anulu / Rycina 5. Pomiar

pierścienia trójdzielnego / 5. ábra. Tricuspidális anulus méretvétele /

veľkosti trikuspidálneho anulu

Figure 6. Suture placement / Figure 6. Pose des sutures /

Abbildung 6. Anlegen der Nähte / Figura 6. Realización de las suturas /

Figura 6. Applicazione delle suture / Afbeelding 6. Plaatsing van de

hechtingen / Figur 6. Suturplacering / Figur 6. Placering af suturerne /

Figur 6. Suturplassering / Figura 6. Colocação das suturas /

Εικόνα 6. Τοποθέτηση ραμμάτων / Obrázek 6. Umístění stehů /

Rycina 6. Zakładanie szwów / 6. ábra. Öltések elhelyezése /

Şekil 6. Sütürün yerleştirilmesi / Obrázok 6. Umiestnenie stehov

1. Ring in mitral valve / Anneau dans la valve mitrale / Ring in der Mitralklappe / Anillo en la válvula mitral / Anello sulla valvola mitrale / Ring in mitralisklep / Ring i mitralklaffen / Ring i mitralklappen / Ring i mitralklaff / Anel na válvula mitral / Δακτύλιος στη μιτροειδή βαλβίδα / Prstenec v mitrální chlopni / Pierścień zamknięty w zastawce mitralnej / Gyűrű a mitrális billentyűben / Mitral kapak içindeki halka / Prstenec v mitrálnej chlopni

2. Band in mitral valve / Bande dans la valve mitrale / Band in der Mitralklappe / Banda en la válvula mitral / Emianello sulla valvola mitrale / Band in mitralisklep / Band i mitralklaffen / Bånd i mitralklappen / Bånd i mitralklaff / Banda na válvula mitral / Ανοικτός δακτύλιος στη μιτροειδή βαλβίδα / Proužek v mitrální chlopni / Pierścień otwarty w zastawce mitralnej / Pánt a mitrális billentyűben / Mitral kapak içindeki bant / Pásik v mitrálnej chlopni

3. Ring in tricuspid valve / Anneau dans la valve tricuspide / Ring in der Trikuspidalklappe / Anillo en la válvula tricúspide / Anello sulla valvola tricuspide / Ring in tricuspidalisklep / Ring i trikuspidalklaffen / Ring i trikuspidalklappen / Ring i tricuspidalklaff / Anel na válvula tricúspide / Δακτύλιος στην τριγλώχινα βαλβίδα / Prstenec v trikuspidální chlopni / Pierścień zamknięty w zastawce trójdzielnej / Gyűrű a tricuspidális billentyűben / Triküspid kapak içindeki halka / Prstenec v trikuspidálnej chlopni

4. Band in tricuspid valve / Bande dans la valve tricuspide / Band in der Trikuspidalklappe / Banda en la válvula tricúspide / Emianello sulla valvola tricuspide / Band in tricuspidalisklep / Band i trikuspidalklaffen / Bånd i trikuspidalklappen / Bånd i tricuspidalklaff / Banda na válvula tricúspide / Ανοικτός δακτύλιος στην τριγλώχινα βαλβίδα / Proužek v trikuspidální chlopni / Pierścień otwarty w zastawce trójdzielnej / Pánt a tricuspidális billentyűben / Triküspid kapak içindeki bant / Pásik v trikuspidálnej chlopni

Figure 7 / Figure 7 / Abbildung 7 / Figura 7 / Figura 7 / Afbeelding 7 /

Figur 7 / Figur 7 / Figur 7 / Figura 7 / Εικόνα 7 / Obrázek 7 / Rycina 7 /

7. ábra / Şekil 7 / Obrázok 7

Figure 8 / Figure 8 / Abbildung 8 / Figura 8 / Figura 8 / Afbeelding 8 /

Figur 8 / Figur 8 / Figur 8 / Figura 8 / Εικόνα 8 / Obrázek 8 / Rycina 8 /

8. ábra / Şekil 8 / Obrázok 8

Figure 9 / Figure 9 / Abbildung 9 / Figura 9 / Figura 9 / Afbeelding 9 /

Figur 9 / Figur 9 / Figur 9 / Figura 9 / Εικόνα 9 / Obrázek 9 / Rycina 9 /

Figure 10 / Figure 10 / Abbildung 10 / Figura 10 / Figura 10 /

Afbeelding 10 / Figur 10 / Figur 10 / Figur 10 / Figura 10 / Εικόνα 10 /

Obrázek 10 / Rycina 10 / 10. ábra / Şekil 10 / Obrázok 10

9. ábra / Şekil 9 / Obrázok 9

Flexible Annuloplasty Ring/Band

1. Device Description

The Simulus™ flexible annuloplasty ring model 700FF (Figure 1) and the Simulus™ flexible annuloplasty band model 700FC (Figure 2) consist of a flexible braided polyester fabric with a 3-mm cross-section. Both the ring and band may be implanted in the mitral or tricuspid annulus to stabilize the annulus following valve repair. The ring and band are marked at three points by colored sutures. Two markers correspond to the trigones (mitral valve) or septal commissures (tricuspid valve), and a central marker identifies the midpoint of the ring or band. The individual ring or band size (23 to 39 mm in 2-mm increments) refers to the inner circumference between the green trigone markers on the ring or band. Silicone markers, impregnated with barium sulfate and tungsten, enable radiographic visualization. The ring and band are mounted to a holder to ease positioning and implantation.

The Simulus™ flexible annuloplasty band is also available without a holder (model 725FC) in size 25 mm.

2. Indications

The Simulus™ flexible annuloplasty ring and band are indicated for use in patients undergoing surgery for diseased or damaged mitral or tricuspid valves. The Simulus™ flexible annuloplasty ring and band provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

3. Contraindications

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severe, generalized, or localized bacterial endocarditis

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heavily calcified valves

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greatly dilated annulus (not reducible by standard techniques)

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severe valvular dysfunction (not correctable by standard techniques)

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valvular retraction with severely reduced mobility

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congenital malformations with lack of valvular tissue

4. Warnings

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For single use only. Do not resterilize the ring or band.

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Only surgeons who have received adequate training to determine whether incompetent, stenotic, or diseased heart valves are capable of being repaired or replaced should use this device.

22 Instructions for Use English

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Only surgeons who have received appropriate training in valve repair, including ring and band implant and sizing techniques, should use this device.

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Correct annuloplasty ring and band sizing is an important element of a successful valve repair. Undersizing the ring or band can result in valve stenosis. Oversizing the ring or band can result in valve regurgitation.

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During implantation, place horizontal, interrupted or continuous sutures into the annulus following the line of leaflet insertion.

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In the Tricuspid position, do not place sutures in the coronary sinus, right coronary artery, AV node or other conduction tissue, as this may result in impairment of the cardiac conduction system.

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It is necessary to secure the ends of the ring and band into fibrous trigone tissue to maintain permanent attachment of the ring or band.

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Suture knots must be securely tied. Loose knots and long suture tails may be a source for hemolysis, thrombosis, or thromboembolism.

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Do not cut the ring/band, as resultant loose threads can be a source of hemolysis, thrombosis, and/or thromboembolism.

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Intraoperative and/or postoperative echocardiography should be used to evaluate the effectiveness of the valve repair. Minimizing regurgitation and preventing systolic anterior motion (SAM) are important elements of an effective repair.

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Surgeons who use annuloplasty rings and/or bands should be current on all anticoagulation regimens.

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When postoperative anticoagulant therapy is used, the patient’s anticoagulation status should be carefully monitored.

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Patients with intra-atrial thrombi or a giant left atrium may benefit from long-term anticoagulation therapy.

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The surgeon may desire that patients in atrial fibrillation remain on anticoagulation therapy until sinus rhythm is established.

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When placing the implantation sutures, be careful to avoid snaring the spokes of the holder.

5. Precautions

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Do not use cutting edge needles, as they may damage the annuloplasty device potentially leading to ring/band dehiscence, ring/band fracture, and possible mitral or tricuspid regurgitation.

Instructions for Use English 23

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Take care not to damage the annuloplasty ring or band during handling.

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This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

6. Potential Adverse Events

While infrequent, certain complications have been reported when using annuloplasty ring/bands. These include the following:

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uncorrected or recurrent regurgitation

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stenosis

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ring/band dehiscence

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hemolysis (even with mild regurgitation)

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low cardiac output

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heart block

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systolic anterior motion (SAM) and left ventricular outflow tract obstruction (LVOTO)

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damage to coronary arteries

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endocarditis

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thrombosis

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thromboembolism

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anticoagulant-related hemorrhage

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ring/band fracture

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leaflet perforation

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bleeding diathesis

The potential for these complications should be considered when selecting the most beneficial surgical procedure for each patient.

To avoid or minimize occurrence of these adverse events, the annuloplasty repair, including sizing and implantation, should be conducted in accordance with the methods described in these Instructions for Use by surgeons with appropriate training and experience in valve repair.

7. Individualization of Treatment

To allow for healing and incorporation of the annuloplasty ring or band by host tissue, regardless of cardiac rhythm, postoperative anticoagulation therapy should be considered for at least six weeks following surgery.

24 Instructions for Use English

8. Patient Counseling Information

8.1. Patient Dental Care

Patients with annuloplasty rings or bands who undergo dental or other potentially bacteremic procedures must be considered for prophylactic antibiotic therapy.

8.2. MRI Conditions

The Simulus™ flexible annuloplasty ring/band is MR safe. This device contains no metal and therefore poses no known hazards in any Magnetic Resonance (MR) environment.

The device will not cause any harm to the patient when exposed to MR scanning immediately after implantation. MRI at 1.5 and 3.0 Tesla and other field strengths may be performed immediately following the implantation of the device.

The presence of other implants or medical circumstances of the patient may require lower limits on some or all of the above parameters.

9. How Supplied

9.1. Packaging

The Simulus™ flexible annuloplasty ring and band models 700FF and 700FC are available in the following sizes: 23, 25, 27, 29, 31, 33, 35, 37, and 39 mm. The Simulus™ flexible annuloplasty band without a holder, model 725FC, is available in size 25 mm. The products are nonpyrogenic. They are sterilized using irradiation and supplied in double-aseptic transfer pouches contained in an outer carton. The packaging system is designed to ease placement of the device into the sterile field. The ring and band assemblies are sterile if the pouches are undamaged and unopened. The outer surfaces of the outer pouch are NONSTERILE and must not be placed in the sterile field.

9.2. Storage

Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.

The sterility and nonpyrogenicity of the Simulus™ flexible annuloplasty ring/band are validated to remain unaffected until the Use By date identified on the shelf carton, provided the pouches are not opened or damaged.

Instructions for Use English 25

10. Instructions for Use

10.1. Sizing

The Simulus™ flexible annuloplasty ring/band sizers are used to select the proper Simulus™ flexible annuloplasty ring/band size for repair of the mitral or tricuspid valve. Sizers are reusable; however, they must be cleaned and sterilized by autoclave (steam) prior to each use.

Proper ring/band size selection is an important part of valvular annuloplasty to help restore proper function. Use a Simulus™ flexible annuloplasty ring/band sizer set (available in models 750, 751, 755, and 756) and annuloplasty handle (model 752 or 752XL) for size selection (Figure 3).

Handles and sizers are provided NONSTERILE; they must be cleaned and sterilized prior to use. To attach the handle, gently squeeze the two square protrusions on either side of the central slot on the handle and insert it into the sizer or holder.

Warning: Do not use other manufacturers’ annuloplasty sizers or sizers from other Medtronic annuloplasty products to size Simulus™ flexible annuloplasty ring/band. Other ring/band sizers may not indicate the appropriate Simulus™ flexible annuloplasty ring/band size.

10.2. Mitral Annulus Sizing

The size of the Simulus™ flexible annuloplasty ring or band required can be determined by the distance between the trigones (Figure 4). Place sutures in each trigone, approximately 4 mm apart. Lower the sizer onto the valve annulus and align the sizer protrusions with the trigones. Determine the appropriate mitral ring or band size by locating the sizer with a protrusion spacing that best corresponds to the intertrigonal distance, as well as an outer periphery that most closely matches the circumference of the valve annulus. The outer periphery of the sizer (not including the protrusions) corresponds to the midline of the Simulus™ flexible annuloplasty ring/band and indicates where the implantation sutures will be placed on the valve annulus.

10.3. Tricuspid Annulus Sizing

The size of the Simulus™ flexible annuloplasty ring or band required can be determined by the circumferential distance between the anteroseptal and posteroseptal commissures (Figure 5). Place sutures in the septal commissures, approximately 4 mm apart. Lower the sizer onto the valve annulus and align the sizer protrusions with the commissures of the septal leaflet. Determine the appropriate tricuspid ring or band size by locating the sizer with a protrusion spacing that

26 Instructions for Use English

best corresponds to the inter-commissural distance, as well as an outer periphery that most closely matches the circumference of the valve annulus. The outer periphery of the sizer corresponds to the midline of the Simulus™ flexible annuloplasty ring/band and indicates where the implantation sutures will be placed on the valve annulus.

10.4. Handling and Preparation Instructions

1. Open the box and remove the product literature, Patient Registration Form, and envelopes.

2. Remove the double-aseptic transfer pouch containing the device.

3. Inspect the pouches ensuring they have not been opened or damaged. The ring and band assemblies are sterile as long as the inner pouch has not been compromised. If the inner pouch is damaged, do not implant the device.

4. If the outer pouch is damaged, the exterior surface of the inner pouch may not be sterile.

5. Open the outer transfer pouch and, while still holding the bottom of the outer pouch, pass the inner pouch into the sterile field.

6. The inner pouch should be opened only in the sterile field.

10.5. Device Implantation

1. Remove the appropriate size Simulus™ flexible annuloplasty ring or band from the sterile package using aseptic technique.

2. Remove the serial number identification tag by cutting the retaining suture and record the serial number in the patient's record. Verify that the serial number matches the serial number on the Patient Registration Form.

Warning: The serial tag must be removed from the ring/band for proper function. Do not cut or tear the ring/band fabric during removal of the serial tag.

3. For models 700FF and 700FC, insert a handle into the square recess on the holder (Figure 3).

10.6. Mitral Annulus Suture Placement

Ring: Place additional interrupted sutures, approximately 4 mm apart,

in the anterior and posterior portion of the mitral annulus (Figure 6, number 1).

Band: Place additional interrupted sutures, approximately 4 mm apart, in the posterior portion of the mitral annulus (Figure 6, number 2).

Warning: Avoid placing sutures in the circumflex coronary artery.

Instructions for Use English 27

Note: Pledgets may be used for trigone sutures and mid-posterior annulus suture to reduce the possibility of ring/band dehiscence.

10.7. Tricuspid Suture Placement

Ring: Place additional interrupted sutures, approximately 4 mm apart,

in the septal, anterior, and posterior portion of the tricuspid annulus (Figure 6, number 3).

Band: Place additional interrupted sutures, approximately 4 mm apart, in the anterior and posterior portion of the tricuspid annulus (Figure 6, number 4).

Warning: Do not place sutures in the coronary sinus, right coronary artery, AV node, bundle of HIS, or other conduction tissue.

10.8. Ring and Band Suture Placement

1. Orient the ring or band holder/handle assembly on the annulus.

2. Pass sutures through the ring or band, approximately 2 to 4 mm apart, entering at the bottom of the ring/band and exiting the periphery of the ring/band (Figure 7).

3. Place sutures completely around the ring/band.

10.9. Holder/Handle Removal

Note: If implanting model 725FC, skip to step 3.

1. Use the handle to push the ring or band down onto the valve annulus while pulling back on the sutures.

2. Remove the ring/band from the disposable holder by cutting the retention suture on the holder, identified by the word “CUT” and an arrow pointing to the cutting guide slot (Figure 8). Dispose of the holder.

Warning: Do not cut the ring/band fabric while cutting the holder retention suture.

Warning: The holder must be removed from the annuloplasty ring/band at the end of the procedure for proper function. Under no circumstances is the holder to be left attached to the annuloplasty ring/band.

3. Tie all knots around the ring/band securely and trim all excess sutures (Figure 9 and Figure 10).

4. Test valvular competency.

10.10. Accessories

Use one of the Simulus™ flexible annuloplasty ring/band sizer sets to determine the appropriate device size.

28 Instructions for Use English

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