Medtronic AB2214C140CT Instructions for Use

Talent™ Abdominal Stent Graft System

Instructions for Use

IMPORTANT!

• Do not attempt to use the Talent Abdominal Stent Graft with the
CoilTrac Delivery System before completely reading and understanding

the information contained in this booklet.

• Carefully inspect all product packaging for damage or defects prior to use.
Do not use this product if any sign of damage or breach of the sterile barrier
is observed.

• These devices are supplied STERILE for single use only. After use,
dispose of the delivery catheters in accordance with hospital, administrative,
and/or government policy. Do not resterilize.

• Caution: Federal (U.S.) Law restricts this device to sale by or on the order
of a physician

Table of Contents

Talent™ Abdominal Stent Graft System

Instructions for Use

1.0 DEVICE DESCRIPTION...................................................................................................................... 5

1.1 DEVICE COMPONENTS .......................................................................................................................... 7

1.2 DELIVERY SYSTEM ............................................................................................................................... 9

2.0 INDICATIONS..................................................................................................................................... 11

3.0 CONTRAINDICATIONS.................................................................................................................... 11

4.0 WARNINGS AND PRECAUTIONS .................................................................................................. 11

4.1 GENERAL ............................................................................................................................................ 11

4.2 PATIENT SELECTION, TREATMENT, AND FOLLOW-UP......................................................................... 11

4.3 IMPLANT PROCEDURE......................................................................................................................... 12

4.4 MAGNETIC RESONANCE IMAGING (MRI) SAFETY SECTION ............................................................... 13

5.0 ADVERSE EVENTS ............................................................................................................................ 13

5.1 OBSERVED ADVERSE EVENTS ............................................................................................................ 13

5.2 POTENTIAL ADVERSE EVENTS ............................................................................................................ 13

5.3 DEVICE-RELATED ADVERSE EVENTS REPORTING .............................................................................. 13

6.0 SUMMARY OF CLINICAL STUDY ................................................................................................. 14

6.1 STENT GRAFT ANALYSIS .................................................................................................................... 14

6.2 DELIVERY SYSTEM ANALYSIS ............................................................................................................ 14

6.3 PATIENT ACCOUNTABILITY AND FOLLOW-UP .................................................................................... 15

6.4 DEMOGRAPHIC AND BASELINE MEDICAL HISTORY DATA .................................................................. 17

6.5 BASELINE ANEURYSM DATA .............................................................................................................. 19

6.6 DEVICES IMPLANTED .......................................................................................................................... 21

6.7 STUDY RESULTS ................................................................................................................................. 22

6.8 SAFETY............................................................................................................................................... 22

6.9 EFFECTIVENESS .................................................................................................................................. 29

6.10 ACUTE PROCEDURAL DATA.............................................................................................................. 34

6.11 COILTRAC DELIVERY SYSTEM PERFORMANCE DATA....................................................................... 35

7.0 PATIENT SELECTION ...................................................................................................................... 36

7.1 INDIVIDUALIZATION OF TREATMENT .................................................................................................. 36

8.0 PATIENT COUNSELING INFORMATION .................................................................................... 36

9.0 HOW SUPPLIED ................................................................................................................................. 36

9.1 CONTENTS .......................................................................................................................................... 36

9.2 STERILITY AND STORAGE ................................................................................................................... 37

10.0 CLINICAL USE INFORMATION...................................................................................................37

10.1 RECOMMENDED SKILLS AND TRAINING............................................................................................ 37

10.2 MATERIAL RECOMMENDED FOR DEVICE IMPLANTATION ................................................................. 37

10.3 PRE-TREATMENT PLANNING............................................................................................................. 37

11.0 DIRECTIONS FOR USE – STENT GRAFT SYSTEM ................................................................. 39

11.1 PICTORIAL REFERENCES ................................................................................................................... 39

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11.2 VASCULAR ACCESS AND ARTERIOTOMY .......................................................................................... 39

11.3 IMPLANTATION OF THE BIFURCATED STENT GRAFT ......................................................................... 39

11.4 IMPLANTATION OF THE CONTRALATERAL LIMB ............................................................................... 45

11.5 AORTIC AND ILIAC EXTENSIONS....................................................................................................... 47

12.0 IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP.......................................... 49

12.1 GENERAL .......................................................................................................................................... 49

12.2 CONTRAST AND NON-CONTRAST CT RECOMMENDATIONS .............................................................. 49

12.3 ABDOMINAL RADIOGRAPHS ............................................................................................................. 50

12.4 ULTRASOUND ................................................................................................................................... 50

12.5 MRI SAFETY AND COMPATIBILITY ................................................................................................... 50

12.6 ADDITIONAL SURVEILLANCE AND TREATMENT................................................................................ 51

13.0 DEVICE-RELATED ADVERSE EVENTS REPORTING ............................................................ 51

14.0 PATIENT MATERIALS AND TRACKING INFORMATION .................................................... 51

15.0 CONFIGURATIONS AVAILABLE ................................................................................................ 52

16.0 EXPLANATION OF SYMBOLS...................................................................................................... 54

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List of Tables

Table 1: Stent Graft Materials ........................................................................................................................ 5

Table 2: Patient and Imaging Accountability – Test Group1........................................................................ 15

Table 3: Patient Accountability – SVS Control............................................................................................ 16

Table 4: Patient Demographics, Test Group vs. SVS Control...................................................................... 17

Table 5: Baseline Medical History, Test Group vs. SVS Control ................................................................ 18

Table 6: Baseline SVS Classification, Test Group Only.............................................................................. 19

Table 7: Baseline Maximum Aneurysm Diameters, Test Group vs. SVS Control (Site Reported) ............. 19

Table 8: Distribution of Baseline Maximum Aneurysm Diameters, Test Group vs. SVS Control (Site

Reported)...................................................................................................................................................... 19

Table 9: Baseline Aneurysm Characteristics, Test Group............................................................................ 20

Table 10: Total Number of Talent Abdominal Stent Grafts Implanted at Initial Procedure......................... 21

Table 11: Primary Safety Endpoint: Freedom from MAEs within 30 Days, Test Group vs. SVS Control.. 22

Table 12: Primary Safety Endpoint: MAE Components within 30 Days, Test Group vs. SVS Control ...... 22

Table 13: Freedom from MAEs within 365 Days, Test Group vs. SVS Control ........................................ 23

Table 14: MAE Components within 365 Days, Test Group vs. SVS Control............................................. 23

Table 15: Details of Kaplan-Meier Estimates of Freedom from MAEs (0 to 365 Days), Test Group vs.

SVS Control ................................................................................................................................................. 24

Table 16: Freedom from All-Cause Mortality within 30 Days, Test Group vs. SVS Control..................... 25

Table 17: Freedom from Aneurysm-Related Mortality within 365 Days, Test Group vs. SVS Control..... 25

Table 18: Details of Kaplan-Meier Estimates of Freedom from Aneurysm-Related Mortality within 365

Days, Test Group vs. SVS Control.............................................................................................................. 26

Table 19: Freedom from All-Cause Mortality within 365 Days, Test Group vs. SVS Control.................... 27

Table 20: Details of Kaplan-Meier Estimates of Freedom from All-Cause Mortality within 365 Days,

Test Group vs. SVS Control......................................................................................................................... 28

Table 21: Primary Effectiveness Endpoint: Successful Aneurysm Treatment, Test Group ......................... 29

Table 22: Primary Effectiveness Endpoint: Successful Aneurysm Treatment, Test Group ......................... 29

Table 23: Migration-Free at 12 Months, Test Group (Core Lab) ................................................................. 30

Table 24: Stent Graft Patency at 12 Months, Test Group (Core Lab) .......................................................... 30

Table 25: Freedom from Secondary Endovascular Procedures within 365 Days, Test Group..................... 30

Table 26: Loss of Stent Graft Integrity at 12 Months, Test Group (Core Lab) ............................................ 31

Table 27: Type I/III Endoleak-Free at 12 Months, Test Group (Core Lab) ................................................. 31

Table 28: Summary of All Endoleaks at 1 Month and 12 Months, Test Group (Core Lab)......................... 32

Table 29: Aneurysm Rupture within 365 Days, Test Group ........................................................................ 33

Table 30: Aneurysm Change from 1 Month to 12 Months, Test Group (Core Lab and Site-Reported) ..... 33

Table 31: Acute Procedural Data, Test Group and SVS Control ................................................................. 34

Table 32: CoilTrac Delivery System: Delivery and Deployment Success .................................................. 35

Table 33: CoilTrac Delivery System: Patients with Clinically Relevant Adverse Events

[Within 30 Days] .......................................................................................................................................... 35

Table 34: Talent Abdominal Stent Graft System Oversizing Guidelines..................................................... 38

Table 35: Guideline for balloon diameter to volume.................................................................................... 44

Table 36: Recommended Imaging Schedule for Endovascular Graft Patients ............................................. 49

Table 37: Accepted Imaging Protocols......................................................................................................... 50

Table 38: Bifurcated Stent Grafts with the CoilTrac Delivery System ........................................................ 52

Table 39: Contralateral Limbs with the CoilTrac Delivery System ............................................................. 52

Table 40: Iliac Extension Cuffs with CoilTrac Delivery System ................................................................. 53

Table 41: Aortic Extension Cuffs with CoilTrac Delivery System .............................................................. 53

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List of Figures

Figure 1: Overview of Talent Abdominal Stent Graft Components............................................................... 6

Figure 2: Talent Abdominal Bifurcated Stent Graft....................................................................................... 7

Figure 3: Talent Abdominal Contralateral Iliac Limb.................................................................................... 8

Figure 4: Talent Abdominal Iliac (Left) and Aortic (Right) Extension Cuffs ................................................ 8

Figure 5: CoilTrac Delivery System............................................................................................................. 10

Figure 6: Kaplan-Meier Estimates of Freedom from MAEs (0 to 365 Days), Test Group vs. SVS

Control.......................................................................................................................................................... 24

Figure 7: Kaplan-Meier Estimates of Freedom from Aneurysm-Related Mortality within 365 Days, Test

Group vs. SVS Control................................................................................................................................. 26

Figure 8: Kaplan-Meier Estimates of Freedom from All-Cause Mortality within 365 Days, Test Group

vs. SVS Control............................................................................................................................................ 28

Figure 9: Position the System....................................................................................................................... 40

Figure 10: Deploy the Proximal End............................................................................................................ 42

Figure 11: Deploy the Distal End ................................................................................................................. 43

Figure 12: Modeling the Stent Graft with the Balloon ................................................................................. 44

Figure 13: Proper Docking of Contralateral Limb to Contralateral Leg....................................................... 46

Figure 14: Talent Stent Graft System with the Modeling Balloon ............................................................... 47

Figure 15: Orienting Iliac Extension Cuff .................................................................................................... 48

Figure 16: Orienting the Aortic Extension Cuff........................................................................................... 48

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1.0 DEVICE DESCRIPTION

The Talent™ Abdominal Stent Graft System is comprised of two main components: an implantable stent graft and a
disposable delivery system. The pre-loaded stent graft is advanced to the aneurysm location over a guidewire and, upon
retraction of an introducer sheath (graft cover), expands to the indicated diameter. During deployment and expansion, the
stent graft is intended to form proximal and distal seal zones surrounding the aneurysm location.

The Talent Abdominal Stent Graft System is modular and consists of four stent graft component configurations:

• Bifurcated (aorto-iliac)

• Contralateral iliac limb

• Iliac extension cuff

• Aortic extension cuff

Each component is introduced separately into the patient’s vascular system. Each stent graft component is comprised of
nitinol metal springs attached to polyester fabric graft material. For all configurations the proximal and distal springs are
attached to connecting bars to provide additional columnar strength to the stent graft. The springs are sewn to the
polyester fabric graft using polyester suture material. Radiopaque markers, made out of platinum-iridium in the shape of
a figure eight (aka, Figur8), are sewn onto the stent graft to aid in visualization of the stent graft under fluoroscopy and to
facilitate accurate placement of the device. See Table 1 for a listing of stent graft materials and Figure 1 for an overview
of stent graft components.

The stent graft is designed to be placed in the native vessel such that the unconstrained stent graft diameter is larger than
the diameter of the native vessel into which it is to be placed. This “oversizing” helps to exclude the aneurysm from aortic
blood flow and ensure that the stent graft is held in place. The amount of oversizing required is dependent on the
diameter of the native vessel. See Table 34 for oversizing guidelines and Section 15.0 available device configurations.

Table 1: Stent Graft Materials

Stent Graft Component Material

Springs Nitinol wire
Connecting Bar Nitinol wire
Mini-Support Spring (FreeFlo only) Nitinol wire
Stent Fabric Woven polyester
Sutures Braided polyester suture
Figur8 Radiopaque Markers Platinum-Iridium wire

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Figure 1: Overview of Talent Abdominal Stent Graft Components

AORTIC

EXTENSION CUFF

Connecting Bar

Mini-support Spring

BIFURCATED

STENT GRAFT

ILIAC

EXTENSION CUFF

Connecting Bar

Mini-support Spring

CONTRALATERAL

LIMB

Connecting Bar

= Figur8 Radiopaque Marker

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1.1 Device Components

Each of the four stent graft configurations is described in the following section.

1.1.1 Bifurcated Stent Graft

The bifurcated component (Figure 2) is the primary component which is inserted into the patient’s aorta.
The proximal end of all bifurcated stent grafts has a bare spring that is not covered with graft material to
allow for supra-renal fixation. Bifurcated stent grafts with a proximal diameter greater than 22mm have a
mini-support spring to aid in sealing. The proximal end configuration in which a bare spring and mini­support spring are present is called the ‘FreeFlo’ configuration. The proximal end configuration in which a
bare spring is present without a mini-support spring is called a ‘Bare Spring’ configuration.

The stent graft bifurcates into two smaller iliac diameters; one of which is placed into the ipsilateral iliac
artery, and the other of which is available to receive the contralateral iliac component. The distal end of
the short contralateral leg is 14mm in diameter for all sizes of stent grafts so that it can receive all available
contralateral limb stent graft configurations. In contrast the distal end of the ipsilateral leg is available in 12,
14, 16, 18 and 20mm diameters. The distal iliac ends of the stent graft have Closed Web configurations.

140-170mm

Figure 2: Talent Abdominal Bifurcated Stent Graft

22-36mm

50mm

FreeFlo Configuration Shown
[22mm size has Bare Spring configuration
without mini-support spring (not shown in

14mm

Closed Web

Configuration

12-20mm

the figure)]

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1.1.2 Contralateral iliac limb

The contralateral iliac limb component (Figure 3) is implanted after the bifurcated component to provide a
conduit for blood flow into the contralateral iliac artery. The contralateral iliac limb is introduced though the
patient’s contralateral iliac artery and mated to the short contralateral stub leg on the bifurcated stent graft.

The proximal end of the contralateral iliac limb has an Open Web configuration in which the outline of the
most proximal spring is covered. The proximal diameter is 14mm for all limb sizes, so that all limbs can
dock with all available bifurcated stent graft configurations. The distal end of the limb has a Closed Web
configuration.

1.1.3 Aortic and Iliac Extension Cuffs

1.1.3.1 The aortic and iliac extension cuff components (Figure 4) are used to extend the lengths of
implanted devices as needed based on the patient’s anatomy.

Figure 4: Talent Abdominal Iliac (Left) and Aortic (Right) Extension Cuffs

Open Web

Configuration

Closed Web

Configuration

Figure 3: Talent Abdominal Contralateral Iliac Limb

Open Web Configuration

Closed Web Configuration

10-22mm

8-24mm

14mm

75-105mm

8-24mm

FreeFlo Configuration Shown

[22mm size has Bare Spring

configuration without mini-support

spring (not shown in the figure)]

74 - 140mm

Open Web Configuration

22-36mm

26-30mm

22-36mm

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1.2 Delivery System

The CoilTrac Delivery System is a single use, disposable system used to deliver all stent graft configurations.

The CoilTrac Delivery System is shown in Figure 5. It is a flexible catheter constructed of three concentric,
single lumen, polymer shafts (an outer introducer sheath [graft cover], a pushrod, and a guidewire lumen). A
metallic coil with cup plunger is attached to the distal end of the pushrod to maintain stent graft position during
deployment. A polymeric, atraumatic tapered tip is attached to the guidewire lumen at the distal end of the
delivery system to facilitate tracking through tortuous and calcified vessels. The radiopaque, tapered tip and
marker on the distal end of the introducer sheath (graft cover) aid in fluoroscopic visualization. A compliant
balloon is located on the distal end of the delivery system to aid in stent graft modeling if necessary. Various
valves contained within the delivery system maintain hemostasis and prevent blood loss and leaking during the
procedure.

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Figure 5: CoilTrac Delivery System

5

6

7

15

3

2

11

14

12

9

10

20

16

13

1

19

8

4

17

18

20

1 Guidewire Exit Port 11 Stopcock
2 Tuohy Borst 12 Inflation Port
3 Luer Handle 13 Y-Connector
4 Sheath Hub 14 Guidewire Lumen

Introducer Sheath

5

(Graft Cover)
6 Cup Plunger 16 Hemostasis Valve
7 Pushrod Coil Spring 17 Stopcock
8 Radiopaque “Bullet” 18 Sideport Extension
9 Distal Point 19 Radiopaque Marker

10 Tapered Tip 20 Balloon

15 Pushrod

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2.0 INDICATIONS

The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or
without iliac involvement having:

• Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices,
and/or accessories;

• A proximal aortic neck length of ≥ 10mm;

• Proximal aortic neck angulation ≤ 60°;

• Distal iliac artery fixation length of ≥ 15mm;

• An aortic neck diameter of 18–32mm and iliac artery diameters of 8–22mm; and

• Vessel morphology suitable for endovascular repair.

3.0 CONTRAINDICATIONS

The Talent Abdominal Stent Graft is contraindicated in:

• Patients who have a condition that threatens to infect the graft.

• Patients with sensitivities or allergies to the device materials (see Table 1).

4.0 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

• The Talent Abdominal Stent Graft System should only be used by physicians and teams trained in
vascular interventional techniques, including training in the use of the device. Specific training
expectations are described in Section 10.1.

• Always have a vascular surgery team available during implantation or reintervention procedures in the
event that conversion to open surgical repair is necessary

4.2 Patient Selection, Treatment, and Follow-Up

• The Talent Abdominal Stent Graft 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 12.0.

• The Talent Abdominal Stent Graft System is not recommended in patients who cannot tolerate contrast
agents necessary for intra-operative and post-operative follow-up imaging.

• The Talent Abdominal Stent Graft System is not recommended in patients exceeding weight and/or size
limits which compromise or prevent the necessary imaging requirements

• Prior to the procedure, pre-operative planning for access and placement should be performed. See
Section 10.3. Key anatomic elements that may affect successful exclusion of the aneurysm include severe
proximal neck angulation (> 60 °); short proximal aortic neck (< 10mm); and thrombus and/or calcium at
the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.
Irregular calcification and/or plaque may compromise the fixation and sealing of the implantation sites.
Necks exhibiting these key anatomic elements may be more conducive to graft migration.

• Iliac conduits may be used to ensure the safe insertion of the delivery system if the patient’s access
vessels (as determined by treating physician) preclude safe insertion of the delivery system.

• Inappropriate patient selection may contribute to poor device performance.

• The safety and effectiveness of the Talent Abdominal Stent Graft System has not been evaluated in

patients who:

 Are less than 18 years of age
 Are pregnant or lactating
 Have a dominant patent inferior mesenteric artery and an occluded or stenotic celiac and/or superior

mesenteric artery

 Have aneurysmal involvement or occlusion (surgically performed or naturally occurring) of the

bilateral internal iliac arteries

 Have vessels and/or aneurysm dimensions that cannot accommodate the Talent Abdominal Stent

Graft as per the indications in Section 2.0.

 Have no distal vascular bed (one vessel lower extremity run-off required)
 Have contraindications for use of contrast medium or anticoagulation drugs
 Have an uncorrectable coagulopathy
 Have a mycotic aneurysm
 Have circumferential mural thrombus in the proximal aortic neck
 Have had a recent (within 3 months) myocardial infarction (MI), cerebral vascular accident (CVA), or

major surgical intervention

 Have traumatic aortic injury
 Have leaking, pending rupture or ruptured aneurysms

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 Have pseudoaneurysms resulting from previous graft placement
 Require a revision to previously placed endovascular stent grafts..
 Have genetic connective tissue disease (e.g., Marfan's or Ehlers-Danlos' Syndromes)
 Have concomitant thoracic aortic or thoracoabdominal aneurysms
 Are patients with active systemic infections

• The long-term performance of endovascular grafts has not yet been established. All patients should be
advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the
performance of their endovascular graft. Patients with specific clinical findings (e.g., endoleaks, enlarging
aneurysms or changes in the structure or position of the endovascular graft) should receive enhanced
follow-up. Specific follow-up guidelines are described in Section 12.0.

• 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 (stent fracture, separation
between bifurcated device and proximal cuffs or limb extensions, if applicable), and 2) contrast and non­contrast 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.

• Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo
secondary interventions or surgical procedures.

• Intervention or conversion to standard open surgical repair following initial endovascular repair should be
considered for patients experiencing enlarging aneurysms and/or endoleak. An increase in aneurysm size
and/or persistent endoleak may lead to aneurysm rupture.

4.3 Implant Procedure

• Exercise care in handling and delivery technique to aid in the prevention of vessel rupture.

• Studies indicate that the danger of micro-embolization increases with increased duration of the procedure.

• Renal complications may occur:

 From an excess use of contrast agents.
 As a result of emboli or a misplaced stent graft. The radiopaque marker along the edge of the stent

• Inadequate seal zone may result in increased risk of leakage into the aneurysm or migration of the stent
graft. Other possible causes of migration are deployment of the proximal spring into a thrombus-filled or
severely angled vessel wall.

• 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.

• Minimize handling of the constrained endoprosthesis during preparation and insertion to decrease the risk
of endoprosthesis contamination and infection.

• Improper placement of the stent graft may also cause an endoleak or occlusion of arteries (other than the
renals), which may prevent blood flow necessary to organs and extremities, necessitating surgical
removal of the device.

• During general handling of the CoilTrac Delivery System, avoid bending or kinking the introducer sheath
(graft cover) because it may cause the Talent Abdominal Stent Graft to prematurely and improperly
deploy.

• Never advance or retract the CoilTrac Delivery System from the vasculature without the use of
fluoroscopy.

• Do not continue advancing any portion of the delivery system if resistance is felt during advancement of
the guidewire or delivery system. Stop and assess the cause of resistance. Vessel or catheter damage
may occur. Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or
tortuous vessels.

• The balloon must be DEFLATED before initiating deployment of the stent graft. If resistance is experience
during initial deployment, check to ensure that the modeling balloon is completely deflated.

• Do not retract the introducer sheath (graft cover) before placing the delivery system in the proper
anatomical position, as this will initiate deployment of the stent graft. The Talent Abdominal Stent Graft
cannot be reconstrained or drawn back into the introducer sheath (graft cover), even if the stent graft is
only partially deployed. If the introducer sheath (graft cover) is accidentally withdrawn, the device will
prematurely deploy and could be placed too high or too low.

• Do not rotate the introducer sheath (graft cover) during deployment, as this may torque the device and
cause it to spin on deployment or cause twisting of the iliac limb.

• High pressure injections of contrast media made at the edges of the stent graft immediately after
implantation can cause endoleaks.

• When ballooning the stent graft, there is an increased risk of vessel injury and/or rupture, and possible
patient death, if the balloon’s proximal and distal radiopaque markers are not completely within the
covered (graft fabric) portion of the stent graft.

• Do not exceed maximum inflation diameter (40mm for the 30mm balloon and 20mm for the 20mm
balloon). Rupture of the balloon may occur. Adhere to balloon inflation parameters as described in this

graft should be aligned immediately below the lower-most renal arterial origin.

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booklet and on the product label. Over-inflation may result in damage to the vessel wall and/or vessel
rupture, or damage to the stent graft.

• Any endoleak left untreated during the implantation procedure must be carefully monitored after
implantation.

4.4 Magnetic Resonance Imaging (MRI) Safety Section

MRI may be used on the graft only under specific conditions. See Section 12.5 for details.

5.0 ADVERSE EVENTS

5.1 Observed Adverse Events

The clinical study for the Test Group was a multicenter, prospective study conducted at 13 sites across the US,
which included 166 test patients. Major adverse events observed in this study are provided in Section 6.7.

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)

• Aneurysm enlargement

• Aneurysm rupture and death

• Aortic damage, including perforation, dissection, bleeding, rupture and death

• Arterial or venous thrombosis and/or pseudoaneurysm

• Arteriovenous 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

• Fever and localized inflammation

• Genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, fistula, incontinence,

hematuria, infection)

• Hepatic failure

• Impotence

• Infection of the aneurysm, device 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., confusion, stroke,

transient ischemic attack, paraplegia, paraparesis, paralysis)

• Occlusion of device or native vessel

• Pulmonary/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)

• Stent graft: improper component placement; incomplete component deployment; component migration; suture
break; occlusion; infection; stent fracture; graft twisting and/or kinking; insertion and removal difficulties; graft
material wear; dilatation; erosion; puncture and perigraft flow

• Surgical conversion to open repair

• Vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous

fistula, dissection.

• 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, hematoma, seroma,

cellulitis)

5.3 Device-Related Adverse Events Reporting

See Section 13.0

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6.0 SUMMARY OF CLINICAL STUDY

6.1 Stent Graft Analysis

The clinical study for the Test Group was a multicenter, prospective study conducted at 13 sites across the US. The
Test Group included patients diagnosed with abdominal aortic aneurysms, with or without involvement of the iliac
arteries. A total of 166 patients were enrolled in this study. An independent core lab reviewed CT scans and
abdominal x-rays to assess aneurysm changes, device position and integrity, and endoleaks. A Clinical Events
Committee (CEC) adjudicated Major Adverse Events (MAEs) for the Test Group.

The Control Group (SVS Control) was a compilation of the pivotal open surgical control groups from three approved
abdominal aortic aneurysm (AAA) endograft Premarket Approval (PMA) submissions. The SVS Control represented
a change from the original IDE protocol, and was used because the SVS Control was more comprehensive than the
original IDE Control Group. The data aggregation and analysis were conducted under the auspices of the Society
for Vascular Surgery (SVS). Outcomes from a total of 243 patients treated at facilities across the US were included
in the SVS Control.

The pivotal analysis included endpoints that were modified from the endpoints listed in the original IDE protocol to
endpoints and other metrics that are consistent with current literature and other EVAR clinical studies. The primary
safety endpoint for this analysis was the proportion of patients free from a MAE within 30 days of the index
procedure (based on a composite MAE rate), compared to the open surgical control. The primary effectiveness
endpoint for this analysis was successful aneurysm treatment
based on follow-up at pre-discharge, 1 month, 6 months, and 12 months.

6.2 Delivery System Analysis

Subsequent to enrollment in the pivotal trial, the delivery system was updated to the CoilTrac Delivery System. In
order to evaluate the clinical performance of the CoilTrac Delivery System, a single-center cohort of 137 patients
from an independent data set was evaluated.

The analysis of this independent data set supports the clinical performance of the CoilTrac Delivery System,
demonstrated by delivery and deployment success rate, as well as, clinically relevant adverse events rates observed
within the 30 day post-procedure period.

1

. Other study endpoints and analyses were presented

1

Successful aneurysm treatment was a composite endpoint including patients who had technical success (successful delivery and

deployment of the Talent Stent Graft) at the initial procedure and were free from:

• Aneurysm growth > 5mm at 12 months, as evaluated by the core lab; and

• Post-operative interventions to correct Type I/III endoleaks at anytime up to 12 months (Type II endoleaks are generally

considered to be non-device related).

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6.3 Patient Accountability and Follow-Up

For the Test Group, 13 sites enrolled a total of 166 patients. Four (4) patients had technical failure and did not
receive a stent graft and therefore did not have any imaging follow-up. 162 patients who received the stent graft
were eligible for clinical and imaging follow-up at 1 month follow-up interval. Of these 162 patients, 100% (162/162)
had a clinical follow-up and 98.8% (160/162) had imaging follow-up. CT imaging was performed on 96.3% (156/162)
patients.

At the 6 month follow-up interval, 152 patients were eligible for clinical and imaging follow-up. Of these, 90.1%
(137/152) had clinical follow-up and 81.6 % (124/152) had imaging follow-up. CT imaging was performed on 78.9%
(120/152) patients.

At the 12 month follow-up interval, 142 patients were eligible for clinical and imaging follow-up. Of these 97.2%
(138/142) had clinical follow-up and 93.0% (132/142) had imaging follow-up. CT imaging was performed on 91.5%
(130/142) patients.

Detailed patient accountability and follow-up is provided in Table 2

1

Table 2: Patient and Imaging Accountability – Test Group

Patient follow-up

Patients with

imaging

performed at

time interval

(Core Lab)

Patients with adequate

imaging to assess the

parameter

Patient events occurring before next

visit

Interval

(Analysis

Window)

Originally

Enrolled

Events after

implant but

before a 1Month

visit

1 Month

(Day 1-90)

Events after 1
Month visit but

before a 6

Month visit

6 Month

(Day 91-304)

Events after 6
Month visit but

before a 12

Month visit

12 Month

(≥ Day 305

1

Data analysis sample size varies for each of the timepoints above and in the following tables. This variability is due to

Eligible

Clinical

Imaging

Follow-up

Follow-up

CT Imaging

166

162 162 160 156 141

152 137 124 120 103 118 114 120 101

142 138 132 130 112 128 120 128 110

2

)

4

0 0 0 0

0 5 5 0

0 5 5 0

KUB Imaging

Aneurysm

Endoleak

size increase

150 143 136

Migration

Integrity

Failure

Technical

Conversion to

Death

Surgery

Lost to

Withdrawal

patient availability for follow-up, as well as, quantity and quality of images available from specific timepoints for evaluation.
For example, the number and quality of images available for evaluation of endoleak at 6 months is different than the number
and quality of images available at 12 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.

2

In cases where 12 month imaging follow-up data were not available, subsequent imaging follow-up data were used.

Follow-up

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The SVS Control included 243 patients. Detailed patient accountability and follow-up is provided in Table 3 below.
At the 1 month follow-up interval, 239 patients were eligible and 98.7% (236/239) had clinical follow-up. At the 6
month follow-up interval, 230 patients were eligible and 90.9% (209/230) had clinical follow-up. At the 12 month
follow-up interval, 219 patients were eligible and 97.7% (214/219) had clinical follow-up.

Table 3: Patient Accountability – SVS Control

Interval
(Analysis Window)

Originally enrolled 243

Patient follow-up

Eligible

Clinical Follow-

up Death

Patients with events occurring

before next visit

Withdrawal/ Lost

to Follow-up

Events after procedure but
before 1 Month visit

1 Month visit
(Day 1-90)

Events after 1 Month visit
but before 6 Month visit

6 Month visit
(Day 91-304)

Events after 6 Month visit
but before 12 Month visit

12 Month visit
(≥ Day 305)

4 0

239 236

7 2

230 209

5 6

219 214

16