Medtronic AB2214C140XH Instructions for Use
Talent™ Abdominal Stent Graft System
with Xcelerant
®
Hydro Delivery System
Instructions for Use
• Do not attempt to use the Talent Abdominal Stent Graft with Xcelerant Hydro
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
IMPORTANT!
M708500B001
Talent™ Abdominal Stent Graft with Xcelerant Hydro Delivery System
Instructions for Use: Table of Contents
Section Page
1.0 DEVICE DESCRIPTION ......................................................................................................5
1.1 Device Components .........................................................................................................7
1.2 Xcelerant Hydro Delivery System (HDS) ..........................................................................9
2.0 INDICATIONS ....................................................................................................................10
3.0 CONTRAINDICATIONS.....................................................................................................10
4.0 WARNINGS AND PRECAUTIONS ...................................................................................10
4.1 General...........................................................................................................................10
4.2 Patient Selection, Treatment, and Follow-Up .................................................................10
4.3 Implant Procedure ..........................................................................................................11
4.4 Magnetic Resonance Imaging (MRI) Safety Section......................................................12
5.0 ADVERSE EVENTS...........................................................................................................12
5.1 Observed Adverse Events..............................................................................................12
5.2 Potential Adverse Events ...............................................................................................12
5.3 Device-Related Adverse Events Reporting ....................................................................12
6.0 SUMMARY OF CLINICAL STUDY ....................................................................................12
6.1 Stent Graft Analysis........................................................................................................12
6.2 Delivery System Analysis ...............................................................................................13
6.3 Patient Accountability And Follow-Up.............................................................................13
6.4 Demographic and Baseline Medical History Data ..........................................................16
6.5 Baseline Aneurysm Data ................................................................................................18
6.6 Devices Implanted ..........................................................................................................20
6.7 Study Results .................................................................................................................20
6.8 Safety .............................................................................................................................20
6.9 Effectiveness ..................................................................................................................28
6.10 Acute Procedural Data .................................................................................................31
6.11 CoilTrac Delivery System Performance Data ...............................................................33
7.0 PATIENT SELECTION ......................................................................................................34
7.1 Individualization of Treatment.........................................................................................34
8.0 PATIENT COUNSELING INFORMATION.........................................................................34
9.0 HOW SUPPLIED ...............................................................................................................34
9.1 Contents .........................................................................................................................34
9.2 Sterility and Storage .......................................................................................................35
10.0 CLINICAL USE INFORMATION ......................................................................................35
10.1 Recommended Skills and Training...............................................................................35
10.2 Materials Recommended for Device Implantation ......................................................35
10.3 Pre-Treatment Planning ...............................................................................................36
11.0 DIRECTIONS FOR USE – TALENT ABDOMINAL STENT GRAFT WITH
XCELERANT HDS ...........................................................................................................37
11.1 Pictorial References .....................................................................................................37
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For pictorial references of the Talent Abdominal Stent Graft components with the
Xcelerant HDS refer to Figure 1 and Figure 5 respectively..................................................37
11.2 Vascular Access and Arteriotomy ................................................................................37
11.3 Implantation of the Bifurcated Stent Graft ....................................................................37
11.4 Deploy Distal End .........................................................................................................41
11.5 Delivery System Removal ............................................................................................41
11.6 Preparation of the Contralateral limb with the Xcelerant HDS .....................................42
11.7 Implantation of the Contralateral Limb .........................................................................42
11.8 Confirm Position ...........................................................................................................43
11.9 Deploy Stent Graft ........................................................................................................44
11.10 Remove Delivery System ...........................................................................................44
11.11 Stent Graft Balloon Modeling......................................................................................45
11.12 Procedure Completion................................................................................................46
11.13 Aortic and Iliac Extensions .........................................................................................47
11.14 Handle Dis-assembly Technique................................................................................48
12.0 IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP...................................48
12.1 General.........................................................................................................................48
12.2 Contrast And Non-Contrast CT Recommendations .....................................................49
12.3 Abdominal Radiographs ...............................................................................................49
12.4 Ultrasound ....................................................................................................................50
13.0 MRI SAFETY AND COMPATIBILITY...............................................................................50
14.0 ADDITIONAL SURVEILLANCE AND TREATMENT .......................................................50
15.0 DEVICE-RELATED ADVERSE EVENTS REPORTING..................................................51
16.0 DEVICE REGISTATION PACKET ...................................................................................51
17.0 CONFIGURATIONS AVAILABLE ....................................................................................52
18.0 EXPLANATION OF SYMBOLS........................................................................................55
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List Of Tables
Table 1: Stent Graft Materials ..................................................................................................5
Table 2: Patient and Imaging Accountability – Test Group
1
................................................... 14
Table 3: Patient Accountability – SVS Control .......................................................................15
Table 4: Patient Demographics, Test Group vs. SVS Control ...............................................16
Table 5: Baseline Medical History, Test Group vs. SVS Control ...........................................17
Table 6: Baseline SVS Classification, Test Group Only......................................................... 18
Table 7: Baseline Maximum Aneurysm Diameters, Test Group vs. SVS Control (Site
Reported) ...............................................................................................................................18
Table 8: Distribution of Baseline Maximum Aneurysm Diameters,........................................ 18
Table 9: Baseline Aneurysm Characteristics, Test Group ..................................................... 19
Table 10: Total Number of Talent Abdominal Stent Grafts Implanted at Initial Procedure ....20
Table 11: Primary Safety Endpoint: Freedom from MAEs within 30 Days, Test Group vs. SVS
Control.................................................................................................................................... 20
Table 12: Primary Safety Endpoint: MAE Components within 30 Days, Test Group vs.
SVS Control ...........................................................................................................................21
Table 13: Freedom from MAEs within 365 Days, ..................................................................21
Table 14: MAE Components within 365 Days,....................................................................... 22
Table 15: Details of Kaplan-Meier Estimates of Freedom from MAEs (0 to 365 Days),
Test Group vs. SVS Control................................................................................................... 23
Table 16: Freedom from All-Cause Mortality within 30 Days, Test Group vs. SVS
Control.................................................................................................................................... 24
Table 17: Freedom from Aneurysm-Related Mortality within 365 Days, Test Group vs.
SVS Control ...........................................................................................................................24
Table 18: Details of Kaplan-Meier Estimates of Freedom from Aneurysm-Related
Mortality within 365 Days, Test Group vs. SVS Control......................................................... 25
Table 19: Freedom from All-Cause Mortality within 365 Days, Test Group vs. SVS
Control.................................................................................................................................... 26
Table 20: Details of Kaplan-Meier Estimates of Freedom from All-Cause Mortality
within 365 Days...................................................................................................................... 27
Table 21: Primary Effectiveness Endpoint: Successful Aneurysm Treatment, Test Group... 28
Table 22: Primary Effectiveness Endpoint: Successful Aneurysm Treatment, Test Group... 28
Table 23: Migration-Free at 12 Months, Test Group (Core Lab)............................................ 29
Table 24: Stent Graft Patency at 12 Months, Test Group (Core Lab).................................... 29
Table 25: Freedom from Secondary Endovascular Procedures within 365 Days, Test
Group .....................................................................................................................................29
Table 26: Loss of Stent Graft Integrity at 12 Months, Test Group (Core Lab) ....................... 30
Table 27: Type I/III Endoleak-Free at 12 Months, Test Group (Core Lab) ............................30
Table 28: Summary of All Endoleaks at 1 Month and 12 Months, Test Group (Core Lab).... 31
Table 29: Aneurysm Rupture within 365 Days, Test Group................................................... 31
Table 30: Aneurysm Change from 1 Month to 12 Months, .................................................... 31
Table 31: Acute Procedural Data, Test Group and SVS Control ...........................................32
Table 32: CoilTrac Delivery System: Delivery and Deployment Success ............................. 33
Table 33: CoilTrac Delivery System: Patients with Clinically Relevant Adverse Events [Within
30 Days] ................................................................................................................................. 33
Table 34: Talent Abdominal Stent Graft with Xcelerant HDS Oversizing Guidelines ............ 36
Table 35: Recommended Imaging Schedule for Endovascular Graft Patients...................... 49
Table 36: Accepted Imaging Protocols .................................................................................. 49
Table 37: Bifurcated Stent Grafts with the Xcelerant HDS Delivery System..........................52
Table 38: Contralateral Limbs with the Xcelerant HDS Delivery System............................... 53
Table 39: Iliac Extension Cuffs with the Xcelerant HDS Delivery System ............................. 53
Table 40: Aortic Extension Cuffs with the Xcelerant HDS Delivery System...........................54
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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: Talent AAA Stent Graft with the Xcelerant HDS ....................................................... 9
Figure 6: Kaplan-Meier Estimates of Freedom from MAEs (0 to 365 Days), Test Group
vs. SVS Control...................................................................................................................... 23
Figure 7: Kaplan-Meier Estimates of Freedom from Aneurysm-Related Mortality within
365 Days, Test Group vs. SVS Control................................................................................. 25
Figure 8: Kaplan-Meier Estimates of Freedom from All-Cause Mortality within 365 Days,
Test Group vs. SVS Control................................................................................................... 27
Figure 9: Introduce the System for the Bifurcated Segment ..................................................38
Figure 10: Position the System .............................................................................................. 39
Figure 11: Deploy the Proximal End ......................................................................................40
Figure 12: Deploy the Distal End............................................................................................41
Figure 13: Use the Quick Disconnect to Retract the Tapered Tip .........................................42
Figure 14: Introduce the Contralateral Limb .......................................................................... 43
Figure 15: Position Contralateral Limb................................................................................... 44
Figure 16: Remove the Delivery System................................................................................ 45
Figure 17: Iliac Extension Cuffs .............................................................................................47
Figure 18: Orienting the Aortic Extension Cuff....................................................................... 47
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1.0 DEVICE DESCRIPTION
The Talent™ Abdominal Stent Graft with the Xcelerant
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 the 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 16.0 for
available device configurations
®
Hydro Delivery System (HDS) comprises of two main
Table 1: Stent Graft Materials
Stent Graft Component Material
Springs Nitinol wire (Nickel-Titanium alloy)
Connecting Bar Nitinol wire (Nickel-Titanium alloy)
Mini-Support Spring (FreeFlo only) Nitinol wire (Nickel-Titanium alloy)
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
Mini-support Spring
Note: Figure 1 and Figure 2 are representations only. The Talent Abdominal Stent Graft may appear differently
when viewed under fluoroscopy.
.
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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 mini-support 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.
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.
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
the figure)]
14mm
Closed Web
Configuration
12-20mm
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1.1.3 Aortic and Iliac Extension Cuffs
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.
Open Web
Configuration
Closed Web
Configuration
Open Web Configuration
Closed Web Configuration
Figure 4: Talent Abdominal Iliac (Left) and Aortic (Right) Extension Cuffs
8-24mm
Figure 3: Talent Abdominal Contralateral Iliac Limb
14mm
75-105mm
8-24mm
10-22mm
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 Xcelerant Hydro Delivery System (HDS)
The stent graft is loaded inside the Xcelerant HDS. The Xcelerant HDS is a hydrophilic coated delivery
system as shown in
Figure 5, which facilitate the placement of the stent graft via the arterial vasculature (e.g., femoral
arteries). Using fluoroscopic guidance, the Xcelerant HDS is properly positioned within the patient’s
vasculature and the stent graft is deployed from the Xcelerant HDS.
The Xcelerant HDS consists of:
• A single use, disposable system with an integrated handle to provide the user with controlled
deployment.
• A flexible catheter assembly compatible with a 0.035” guidewire.
• Three concentric single lumen polymer shafts (an outer hydrophilic coated graft cover shaft with an
inner member shaft, and a guidewire lumen).
• A polymeric, atraumatic tip attached at the distal end to facilitate tracking through tortuous and
calcified vessels.
• A radiopaque tip, a marker at the distal end of the stent graft, and a marker on the distal end of the
graft cover to aid in fluoroscopic visualization.
• O-rings contained within the delivery system to maintain hemostasis during the procedure.
Retraction of the graft cover allows deployment of the self-expanding stent grafts. Post deployment, the
physician will recapture the tip of the delivery system by retracting the inner member.
Figu re 5: Tal en t AAA Sten t G raft w ith the X celeran t HDS
5
6
7
8
10
11
2
A
B
1
Detail A
12
13
Detail B
9
3
4 2
1. Stent Stop 8. Trigger
2. Graft Cover 9. Front Grip
3. RO Marker 10. Handle
4. RO Tapered Tip Disassembly Ports
5. Rear Grip 11. Strain Relief
6. Screw Gear 12. Touhy Bourst
7. Slider 13. Quick Disconnect
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INDICATIONS
The Talent Abdominal Stent Graft with Xcelerant HDS 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.
2.0 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)
3.0 WARNINGS AND PRECAUTIONS
3.1 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 9.1.
• Always have a vascular surgery team available during implantation or reintervention procedures in the
event that conversion to open surgical repair is necessary
3.2 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 11.0.
• 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 9.3. 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 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 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
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
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• 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 11.0.
• 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 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.
• 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.
3.3 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 embolic or misplaced stent graft. The radiopaque marker along the edge of the
stent graft should be aligned immediately below the lower-most renal arterial origin.
• 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 Xcelerant HDS, avoid bending or kinking the graft cover because it
may cause the Talent Abdominal Stent Graft to prematurely and improperly deploy.
• Never advance or retract the Xcelerant HDS 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.
• When aligning the position of the Xcelerant HDS so that the Talent Abdominal Stent Graft is in
proper position for deployment within the vessel, be sure that the fluoroscope is angled
perpendicularly to the center line of the infrarenal aorta to avoid parallax or other sources of
visualization error. Align the target area/fixation zone (e.g., neck) in the center of the field. Some
cranial-caudal angulation of the i-i tube may be necessary to achieve this, especially if there is
anterior angulation of the aneurysm neck.
• Before initial deployment, it is suggested to position the stent graft slightly higher than the targeted
location.
• Do not retract the 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 graft cover, even if the stent graft is only partially deployed. If
the graft cover is accidentally withdrawn, the device will prematurely deploy and could be placed
too high or too low.
• When using the trigger to rapidly deploy the stent graft, be sure to hold the front grip of the delivery
system stationary. Do not rotate the graft cover during this step.
• Do not rotate the 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.
• Any endoleak left untreated during the implantation procedure must be carefully monitored after
implantation.
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3.4 Magnetic Resonance Imaging (MRI) Safety Section.
MRI may be used on the graft only under specific conditions. See Section 12.0 for details.
4.0 ADVERSE EVENTS
4.1 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 4.0.
4.2 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)
4.3 Device-Related Adverse Events Reporting
See Section 14.0
5.0 SUMMARY OF CLINICAL STUDY
5.1 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
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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
and analyses were presented based on follow-up at pre-discharge, 1 month, 6 months, and 12 months.
5.2 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.
5.3 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
. Other study endpoints
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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Patient follow-up
Table 2: Patient and Imaging Accountability – Test Group1
Patients
with
imaging
performed
at time
Patients with adequate
imaging to assess the
parameter
Patient events occurring before
interval
(Core Lab)
next visit
Interval
(Analysis
Window)
Originally
Enrolled
166
Eligible
Clinical
Imaging
Follow-up
Follow-up
KUB
CT Imaging
Imaging
size
increase
Aneurysm
Endoleak
Migration
Integrity
Failure
Technical
Conversion
4
Death
to Surgery
Withdrawal
Lost to
Events after
implant but
before a
0 0 0 0
1Month visit
1 Month
(Day 1-90)
162 162 160 156 141
150 143 136
Events after 1
Month visit but
before a 6
0 5 5 0
Month visit
6 Month
(Day 91-304)
152 137 124 120 103 118 114 120 101
Events after 6
Month visit but
before a 12
0 5 5 0
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
142 138 132 130 112 128 120 128 110
2
)
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.
Follow-up
2
In cases where 12 month imaging follow-up data were not available, subsequent imaging follow-up data were used.
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 followup. 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.
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Table 3: Patient Accountability – SVS Control
Patient follow-up
Patients with events occurring
before next visit
Interval
(Analysis Window)
Originally enrolled 243
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)
Eligible
4 0
239 236
7 2
230 209
5 6
219 214
Clinical Follow-
up Death
Withdrawal/ Lost
to Follow-up
15
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