Medtronic CVF3616C124XH Instructions for Use

Talent® Converter Stent Graft

with Xcelerant® Hydro Delivery System

Instructions for Use

• Do not attempt to use the Talent Converter 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!

Talent® Converter Stent Graft with Xcelerant Hydro Delivery System

Instructions for Use

Table of Contents

Section Page

1.0 DEVICE DESCRIPTION ......................................................................................................4

1.1 Device Components .........................................................................................................4

1.2 Xcelerant Hydro Delivery System (HDS) ..........................................................................6

2.0 INDICATIONS......................................................................................................................7

3.0 CONTRAINDICATIONS ......................................................................................................7

4.0 WARNINGS AND PRECAUTIONS .....................................................................................7

4.1 General.............................................................................................................................7

4.2 Patient Selection...............................................................................................................8

4.3 Implant Procedure ............................................................................................................9

4.4 Magnetic Resonance Imaging (MRI) Safety...................................................................10

5.0 ADVERSE EVENTS ..........................................................................................................10

5.1 Potential Adverse Events ...............................................................................................10

5.2 Device-Related Adverse Events Reporting ....................................................................11

6.0 SUMMARY OF CLINICAL STUDY ...................................................................................11

7.0 PATIENT SELECTION AND TREATMENT ......................................................................11

7.1 Individualization of Treatment.........................................................................................11

8.0 PATIENT COUNSELING INFORMATION ........................................................................12

9.0 HOW SUPPLIED ...............................................................................................................12

10.0 CLINICAL USE INFORMATION......................................................................................13

10.1 Patient selection: ..........................................................................................................13

10.2 Physician skills and experience:...................................................................................13

10.3 Materials Recommended for Device Implantation .......................................................13

10.4 Converter Sizing Guidelines .........................................................................................14

11.0 DIRECTIONS FOR USE: TALENT CONVERTER STENT GRAFT WITH

XCELERANT HDS...................................................................................................................17

11.1 Pictorial References .....................................................................................................17

11.2 Vascular Access and Arteriotomy ................................................................................17

11.3 Implantation of the Converter Stent Graft.....................................................................17

11.4 Deploy Distal End .........................................................................................................21

11.5 Delivery System Removal ............................................................................................21

11.6 Placement of the iliac extensions .................................................................................22

11.7 Stent Graft Balloon Modeling........................................................................................23

11.8 Occluder Placement .....................................................................................................23

11.9 Procedure Completion..................................................................................................24

11.10 Femoral-to-Femoral Crossover ..................................................................................24

11.11 Entry Site Closure.......................................................................................................24

11.12 Handle Dis-assembly Technique................................................................................24

12.0 IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP..................................25

12.1 General.........................................................................................................................25

12.2 Contrast And Non-Contrast CT Recommendations .....................................................26

12.3 Abdominal Radiographs ...............................................................................................26

12.4 Ultrasound ....................................................................................................................27

12.5 MRI Safety and Compatibility .......................................................................................27

13.0 ADDITIONAL SURVEILLANCE AND TREATMENT ......................................................28

14.0 POST APPROVAL REGISTRY .......................................................................................28

15.0 DEVICE – RELATED ADVERSE EVENTS REPORTING...............................................28

16.0 DEVICE REGISTRATION PACKET................................................................................28

17.0 CONFIGURATIONS AVAILABLE ...................................................................................30

18.0 EXPLANATION OF SYMBOLS.......................................................................................32

List of Tables

Table 1: Stent Graft Materials ..................................................................................................4

Table 2: Sizing guidelines for the Talent Converter Stent Graft deployed Flush within the

Talent /AneuRx Bifurcated Stent Grafts.................................................................................14

Table 3: Talent Converter Stent Graft with Xcelerant HDS Sizing Guidelines .......................16

Table 4: Recommended Imaging Schedule for Talent Converter Stent Graft Patients .........26

Table 5: Accepted Imaging Protocols ....................................................................................26

Table 6: Converter Stent Grafts with the Xcelerant Hydro Delivery System.......................... 30

Table 7: Iliac Extensions with the Xcelerant Hydro Delivery System .....................................31

List of Figures

Figure 1: Overview of Talent Converter Stent Graft................................................................. 5

Figure 2: Talent Converter Stent Graft with the Xcelerant HDS ..............................................6

Figure 3: Introduction of the Converter System .....................................................................18

Figure 4: Position the system.................................................................................................19

Figure 5: Deploy Proximal End ..............................................................................................20

Figure 6: Deploy the Distal End .............................................................................................20

Figure 7: Use the Quick Disconnect to Retract the Tapered Tip ...........................................21

Figure 8: Remove the Delivery System..................................................................................22

Figure 9: Iliac Extension.........................................................................................................22

Figure 10: Stent Graft Balloon Modeling ................................................................................23

Figure 11: Occluder Placement ............................................................................................. 24

Figure 12: Overview of Talent Converter Stent Graft............................................................. 30

1.0 DEVICE DESCRIPTION

The Talent components: an implantable stent graft and a disposable delivery system. The pre-loaded stent graft is advanced to the aneurysm location over a guide wire and, upon retraction of the graft cover, expands to the indicated diameter.

The Talent Converter Stent Graft component is comprised of nitinol metal springs attached to polyester fabric graft material. 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 (a.k.a., 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 the Talent Converter Stent Graft.

The Talent Converter Stent Graft is designed to be placed within in a Talent or AneuRx Bifurcated Stent Graft for secondary endovascular treatment of the bifurcated stent grafts. See Table 2 and Table 3 for sizing guidelines and Section 17.0 for available device configurations.

Converter Stent Graft with the Xcelerant® Hydro Delivery System (HDS) is comprised of two (2) 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

1.1 Device Components

The Talent Converter Stent Graft configuration is described in the following section.

1.1.1 Talent Converter Stent Graft

The proximal end of all Talent Converter Stent Grafts has a bare spring that is not covered with graft material to allow for supra-renal fixation. Converter Stent Grafts with a proximal diameter greater than 22 mm 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 distal iliac ends of the stent graft have Closed W eb configurations and are 16 mm in diameter.

The Talent Converter Stent Graft with Xcelerant Hydro Delivery System is indicated for secondary endovascular intervention in patients having received prior endovascular repair of abdominal aortic aneurysms (AAA) using the Talent or AneuRx Bifurcated Stent Grafts, in which there is inadequate proximal fixation, seal, overlapping of modular components or unattainable contralateral limb cannulation.

The Converter component can be placed into the pre-existing Talent or AneuRx Bifurcated Stent Graft, with the proximal edge of the graft material:

a. Deployed flush with the fabric edge of the pre-existing bifurcated stent graft b. Deployed up to a maximum of 34 mm proximally to the fabric edge of the pre-existing

The distal end of the Converter is placed into the ipsilateral limb of the bifurcated stent graft. A femoral-femoral artery bypass, combined with the placement of a Talent Occluder component, is typically performed in order to exclude retrograde blood flow from the other iliac artery into the aneurysm sac.

bifurcated stent graft

Figure 1: Overview of Talent Converter Stent Graft

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

the figure)]

Closed Web

Configuration

22-36 mm

124-126 mm

Note: Figure 1 is a representation only. The Talent Converter Stent Graft may appear differently when viewed

under fluoroscopy.

16mm

= Figur8 Radiopaque Marker

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 2, which facilitates the placement of the stent graft via the arterial vasculature (for example, 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” guide wire

• Three (3) concentric single lumen polymer shafts (an outer hydrophilic coated graft cover shaft with

an inner member shaft, and a guide wire 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 graft. Post deployment, the physician will recapture the tip of the delivery system by retracting the inner member.

Figure 2: Talent Converter Stent Graft with the Xcelerant HDS

4 2

Detail A

Detail B

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

2.0 INDICATIONS

The Talent Converter Stent Graft with Xcelerant Hydro Delivery System is indicated for secondary endovascular intervention in patients having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms using the Talent or AneuRx Bifurcated Stent Grafts, in which there is inadequate proximal fixation, seal, overlapping of modular components or unattainable contralateral limb cannulation.

The anatomical considerations are as follows:

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

• Adequate proximal fixation site:

• Adequate distal fixation site:

• with a length from the lowest renal artery to the proximal fabric edge of the previously placed

bifurcated stent graft between 0 mm and 34 mm

• with a vessel diameter of ≥ 18 mm and ≤ 32 mm

• proximal aortic neck angulation ≤ 60° relative to the long axis of the aneurysm

• For the converter used without an iliac extension the landing zone of the distal fixation site within

the bifurcated graft segment of ≤ 16 mm in diameter and at least 30 mm in overlap length (between the bifurcation and distal end of the Talent Converter)

• For the Converter used in combination with an iliac extension, distal fixation site within the iliac artery greater than 15 mm in length and 8 mm to 22 mm in diameter

3.0 CONTRAINDICATIONS

The Talent Converter 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)

• Patients with a pre-existing iliac extension with a distal diameter of ≤ 8 mm

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 Converter Stent Graft System should only be used by physicians and teams trained in vascular interventional techniques. Additionally, the Converter Stent Graft should only be used by those who have received both general Talent Xcelerant Hydro training and training in the use of this device. Specific training expectations are described in Section 10.0

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

• The Talent Converter is not intended as a stand alone device to repair abdominal aneurysms. Rather, the Talent Converter is used for secondary repair of previously placed Talent or AneuRx Bifurcated Stent Grafts or in cases where contralateral gate cannulation is unattainable at the time of the index procedure

• The Talent Converter Graft is designed to provide adequate proximal fixation but may not address deficiencies in previously implanted endovascular grafts or correct the clinical problem caused by the pre-existing graft

• Medtronic has conducted testing to evaluate mechanical interactions between the Talent Converter Stent Graft and the pre-existing Talent or AneuRx Bifurcated Stent Graft. The Talent Converter Stent Graft has not been evaluated for use with any other commercially available bifurcated stent grafts

• Monitoring of the Talent Converter and pre-existing graft combination through clinical and imaging follow-up is required after implantation of the Talent Converter for the following reasons:

• all endovascular grafts require follow-up to ensure continued success of the treatment over

time

• the Talent Converter is intended to be used with a pre-existing endovascular graft having

inadequate proximal fixation/seal or with unattainable contralateral limb cannulation during the index procedure. It may not prevent migration of the pre-existing graft

• a variety of endovascular graft failure modes, and considerable variability in anatomy and

health status between patients precluded evaluation of the Talent Converter in every possible clinical situation to determine patient outcome

• The long-term performance of endovascular grafts with secondary endovascular intervention using additional components has not yet been established. All patients receiving the Talent Converter should receive enhanced follow-up. Specific follow-up guidelines are described in Section 12.0, Imaging Guidelines

• All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft. Patients with specific clinical findings (for example, endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft component) should receive enhanced follow-up. Specific follow-up guidelines are described in Section 12.0, Imaging Guidelines

• Patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at least yearly intervals thereafter. More frequent follow-up may be appropriate for all patients receiving the Talent Converter until stability of the Talent Converter, pre-existing graft, and aneurysm has been established

• After secondary endovascular intervention, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft. At a minimum, imaging should include: 1) abdominal radiographs to examine device integrity (separation between components or stent fracture) and 2) contrast and non-contrast CT to examine aneurysm changes, perigraft flow, patency, tortuosity and disease progression. Only patients with renal complications or other factors precluding the use of image contrast media should be monitored using non-contrast CT and duplex ultrasound or MRI

• Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms, unacceptable fixation length (both the vessel and component overlaps) and/or endoleak. An increase in aneurysm size and/or persistent endoleak may lead to aneurysm rupture

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

4.2 Patient Selection

• In patients with previously implanted AneuRx bifurs, avoid deployment of the Talent Converter in cases which can result in configurations involving three (3) or more layers of graft material overlap where the diameter of the landing zone is ≤ 13 mm. This could potentially cause graft material infolding which may compromise vessel patency

• Care should be exercised in patients receiving the Talent Converter Stent Graft with possible deployment configurations involving four (4) or more layers of stent graft material overlap, as patency may be compromised. (An example where such an overlap may arise is when a Talent Converter with an iliac extension needs to be deployed within a bifur with an iliac extension)

• Lack of non-contrast CT imaging may result in failure to appreciate iliac or aortic calcification, which may preclude access or reliable device fixation and seal

• Pre-procedure CT slice thickness >3 mm may result in sub-optimal device sizing or in failure to appreciate focal stenoses

• Inappropriate patient selection may contribute to poor device performance

• Use of the Talent Converter is recommended in the following situations:

• with a length from the lowest renal artery to the proximal fabric edge of the previously placed

Talent or AneuRx bifurcated Stent Graft between 0 mm and 34 mm (including cases where a bifur in conjunction with an aortic cuff are present)

• with a vessel diameter of >

• proximal aortic neck angulation ≤ 60° relative to the long axis of the aneurysm

• adequate sizing for both the pre-existing graft and the aortic neck is not possible due to

significant diameter differences between the pre-existing graft and the aortic neck (thus excluding the use of an aortic cuff)

• inability to cannulate the contralateral gate of the bifur at the time of the index procedure

• pre-existing graft is unstable (for example, proximal aspect of the pre-existing graft is situated

within the aneurysm sac and an aortic cuff is not considered an appropriate fix)

• Use of the Talent Converter in combination with an iliac extension is recommended in cases where the landing zone of the distal fixation site (within the Talent or AneuRx bifurcated graft segment) is >16 mm in diameter

• Use of the Talent Converter without an iliac extension may be considered if the landing zone of the distal fixation site (within the pre-existing Talent or AneuRx bifurcated Stent Graft leg) is ≤16 mm in diameter and with at least 30 mm in overlap length (between the bifurcation and distal end of the Talent Converter)

• Use of the Talent Converter with an iliac extension may be considered when the distal fixation site within the iliac artery is greater than 15 mm in length and 8 mm to 22 mm in diameter

• Access vessel diameter and morphology (minimal tortuosity, occlusive disease and/or calcification) should be compatible with vascular access techniques and delivery system profiles of 22 to 24 French. Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization

• Prior to the procedure, pre-operative planning for access and placement should be performed. Key anatomic elements that may prevent successful exclusion of the aneurysm include severe proximal neck angulation (>60 degrees relative to the long axis of the aneurysm); short proximal aortic neck (<10 mm); and circumferential thrombus and/or calcification 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. Proximal aortic sealing

18 mm and < 32 mm

zones exhibiting these key anatomic elements may be more conducive to graft migration and/or endoleaks

• The Talent converter is not recommended in patients who:

• cannot tolerate contrast agents necessary for imaging

• will not be compliant with the necessary preoperative, intra-operative and post-operative

imaging and implantation studies as described in Section 12.0

• exceed weight and/or size limits which compromise or prevent the necessary imaging

requirements

• Inability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvic/bowel ischemia

• Multiple large, patent lumbar arteries, mural thrombus and a patent inferior mesenteric artery may all predispose a patient to Type II endoleaks. Patients with uncorrectable coagulopathy may also have an increased risk of Type II endoleak or bleeding complications

4.3 Implant Procedure

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

• The danger of micro-embolization can increase with increased duration of the procedure

• The use of a Talent Converter with Xcelerant Hydro Delivery System (HDS) requires administration

of intravascular contrast. Patients with pre-existing renal insufficiency may have an increased risk of renal failure postoperatively. Care should be taken to limit the amount of contrast media used during the procedure

• 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

• 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

• To activate the hydrophilic coating on the Xcelerant HDS, wipe the surface with a sterile gauze soaked in saline solution. Always keep the graft cover hydrated for optimal performance.

• Maintain guide wire position during delivery system insertion

• Improper placement or fixation of the stent graft may cause an endoleak, migration or occlusion of

arteries (including the renals, internal iliacs), which may prevent blood flow necessary to organs and extremities, necessitating surgical removal of the device. Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications

• Unless medically indicated, do not deploy the Talent Converter in a location that will occlude arteries necessary to supply blood flow to organs or extremities. Do not cover significant renal or mesenteric arteries with the endoprosthesis. Vessel occlusion may occur

• Take care during manipulation of catheters, wires and sheaths within an aneurysm or pre-existing stent graft. Significant disturbances may dislodge fragments of thrombus, which can cause distal embolization

• Before deployment of the Converter, verify that the position of the guide wire extends sufficiently above the aneurysmal area

• Care should be taken not to displace the pre-existing Talent or AneuRx Bifurcated Stent Grafts during the placement and deployment of the Talent Converter

• Care should be taken not to damage or disturb the Converter Stent Graft position in the event that further manipulations of the Converter are required (for example, balloon modeling)

• During general handling of the Xcelerant HDS, avoid bending or kinking the graft cover because it may cause the Talent Converter 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 guide wire 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 Converter 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 (for example, aortic 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 Talent Converter 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 Converter 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

• Do not reposition the Talent Converter Stent Graft if more than two (2) stent rings are deployed as this may result in premature or inaccurate deployment

• Do not deploy the proximal fabric edge of the Talent Converter Stent Graft below the proximal-most fabric edge of the previously placed stent graft (including bifurs used in conjunction with aortic cuffs). This will avoid potential abrasion between the suprarenal stent of the Converter and the fabric of the previously placed stent graft which may lead to stent graft holes

• Do not rotate the graft cover during deployment, as this may torque the device and cause it to spin or twist on deployment

• 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

• 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. Additional procedures may be required in cases of persistent endoleaks

Stent Graft Balloon Modeling

The Reliant should be considered when using the Reliant balloon:

• When ballooning the stent graft, there is an increased risk of vessel injury and/or rupture, and

• Adhere to Reliant balloon inflation parameters as described in the Reliant Balloon Stent Graft

• Confirm complete deflation of balloon prior to balloon repositioning

4.4 Magnetic Resonance Imaging (MRI) Safety

Non-clinical testing has demonstrated that the Talent Converter Stent Graft used in conjunction with the Talent or AneuRx bifurcated stent grafts is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems only using the specific testing parameters listed in Section 12.5

Stent Graft Balloon catheter can be used to assist in stent graft modeling. The following

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

Catheter Instructions for Use. Over-inflation may result in damage to the vessel wall and/or vessel rupture, or damage to the stent graft

5.0 ADVERSE EVENTS

5.1 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

• 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)

• Damage or dislodgement of pre-existing graft

• Death

• Edema

• Embolization (micro and macro) with transient or permanent ischemia or infarction

• Endoleak

• Fever and localized inflammation

• Fistula (e.g., arteriovenous, lymph fistula)

• 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 perigraft flow and corrosion

• 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)

5.2 Device-Related Adverse Events Reporting

Any adverse event (clinical incident) involving the Talent Converter Stent Graft System should be reported to Medtronic Vascular immediately. To report an incident, call (800) 465-5533 (in the US).

6.0 SUMMARY OF CLINICAL STUDY

The safety and effectiveness of the Talent Abdominal Stent Graft product line was evaluated in the U.S clinical study, which did not include the Talent Converter Stent Graft configurations. For clinical study information regarding patients receiving Talent products, please refer to the Talent Abdominal Stent Graft System Instructions for Use. A copy is available on the Medtronic website.

A registry designed to collect information specific to physician experience with the Talent Converter Stent Graft System is required by the FDA. Physicians are strongly requested and highly encouraged to participate in this registry. Analysis of registry data may identify factors affecting patient outcome. For more information about the registry, please go to the Medtronic website (www.medtronic.com).

7.0 PATIENT SELECTION AND TREATMENT

(See Section 4.0 , Warnings and Precautions)

7.1 Individualization of Treatment

Medtronic recommends that the Talent Converter Stent Graft component diameters be selected as described in Table 2 and Table 3. The Talent Converter Stent Graft should extend from the distal edge of the lowest renal artery to a distal fixation point within the ipsilateral limb of the bifurcated stent graft; with a length of 30 mm or more below the bifurcation. All Talent Converter Stent Grafts are designed to fit within the Talent or AneuRx Bifurcated Stent Grafts per Table 2 and Table 3. All lengths and diameters of the devices necessary to complete the procedure should be available to the physician, especially when pre-operative case planning measurements (treatment diameters/lengths) are not certain. This approach allows for greater intra-operative flexibility to achieve optimal procedural outcomes. The warnings and precautions previously described in Section 4.0 should be carefully considered relative to each patient before use of the Talent Converter Stent Graft System. Additional considerations for patient selection include, but are not limited to:

• Patient's age and life expectancy

• Co-morbidities (for example, cardiac, pulmonary or renal insufficiency prior to surgery, morbid

obesity)

• Patient's suitability for open surgical repair

• Patient's anatomical suitability for endovascular repair

• The risk of aneurysm rupture compared to the risks of Talent Converter Stent Graft

• Ability to tolerate general, regional or local anesthesia

• Iliofemoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity)

should be compatible with vascular access techniques of the various delivery catheter profiles (22 and 24 French)

• Use of the Talent Converter is recommended in the following:

• with a length from the lowest renal artery to the proximal fabric edge of the previously placed

Talent or AneuRx Bifurcated Stent Graft between 0 mm and 34 mm

• with a vessel diameter of >

• proximal aortic neck angulation ≤ 60° relative to the long axis of the aneurysm

• adequate sizing for both the pre-existing graft and the aortic neck is not possible due to

significant diameter differences between the pre-existing graft and the aortic neck (thus excluding the use of an aortic cuff)

• pre-existing graft is unstable (for example, proximal aspect of the pre-existing graft is situated

within the aneurysm sac and an aortic cuff is not considered an appropriate fix)

• inability to cannulate the contralateral gate of the bifur at the time of the index procedure

18 mm and < 32 mm

• Use of the Talent Converter without an iliac extension may be considered if the landing zone of the distal fixation site for the Converter (within the pre-existing Talent or AneuRx bifurcated stent graft leg) is ≤16 mm in diameter and with at least 30 mm in overlap length (between the bifurcation and distal end of the Talent Converter)

• Use of the Talent Converter with an iliac extension may be considered when the distal fixation site of the extension within the iliac artery is greater than 15 mm in length and 8 mm to 22 mm in diameter

• Use of the Talent Converter typically requires freedom from significant femoral/iliac artery occlusive disease that would impede flow through the endovascular graft

• Use of the Talent Converter typically requires occlusion of the contralateral iliac artery in conjunction with a standard femoral-femoral bypass procedure. Occlusion of the iliac artery can be performed using a Talent Occluder. For instructions for preparation and deployment of the Talent Occluder, please refer to the Instructions for Use for the Talent Occluder with Occluder Delivery System

• The Talent Converter 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)

• Patients with a pre-existing iliac extension with distal diameter of ≤ 8 mm

• The final treatment decision is at the discretion of the physician and patient

8.0 PATIENT COUNSELING INFORMATION

The physician and patient (and/or family members) should review the risks and benefits when discussing this endovascular device and procedure, including:

• Risks and differences between endovascular repair and surgical repair

• Potential advantages of open surgical repair

• Potential advantages of endovascular repair

• The possibility that subsequent endovascular or open surgical repair of the aneurysm may be required. In

addition to the risks and benefits of an endovascular repair, the physician should assess the patient’s commitment and compliance to postoperative follow-up as necessary to ensure continuing safe and effective results. Listed below are additional topics to discuss with the patient regarding expectations after an endovascular repair:

• The long-term performance of endovascular grafts with secondary endovascular intervention using additional components has not yet been established. All patients receiving the Talent Converter Stent Graft should receive enhanced follow-up. Specific follow-up guidelines are described in Section 12, Imaging Guidelines and Post- Operative Follow-Up

• Patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter. Patients should be told that regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of AAAs. At a minimum, annual imaging and adherence to routine postoperative followup requirements is required and should be considered a life-long commitment to the patient’s health and well-being

• Physicians must advise all patients that it is important to seek prompt medical attention if they experience signs of limb occlusion, aneurysm enlargement or rupture. Signs of graft limb occlusion include pain in the hip(s) or leg(s) during walking or at rest or discoloration or coolness of the leg. Aneurysm rupture may be asymptomatic, but usually presents as: pain; numbness; weakness in the legs; any back, chest, abdominal or groin pain; dizziness; fainting; rapid heartbeat or sudden weakness

• Procedure-related risks include cardiac, pulmonary, neurologic, bowel and bleeding complications. Device-related risks include occlusion, endoleak, migration, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture and death (See Section 5.0, Potential Adverse Events). The physician should complete the Patient I.D. Card and give it to the patient so that he/she can carry it with him/her at all times. The patient should refer to the card anytime he/she visits additional health practitioners, particularly for any additional diagnostic procedures (for example, MRI)

9.0 HOW SUPPLIED

• The Talent Converter with Xcelerant Hydro Delivery System (HDS) is supplied sterile and is intended for single use only. Delivery systems are disposable; do not reuse. Never attempt to resterilize a Talent

Converter Stent Graft or Xcelerant HDS. Resterilization may adversely affect the proper mechanical function of the stent graft or delivery system and could result in patient injury and/or conversion to an open surgical procedure

• In addition to the device, each carton contains one (1) set of patient tracking materials

• 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. Contact your Medtronic Vascular representative for return information

• Prior to use, verify correct device(s) (quantity and size) have been supplied for the patient by matching the device(s) to the order prescribed by the physician for that particular patient

• The Talent Converter Stent Graft is loaded into a 22 or 24 French delivery system. The graft cover of the delivery system is treated with a hydrophilic coating that, when hydrated, enhances trackability

• Do not use after the “USE BY” (expiration) date printed on the label or if the temperature indicator on the box label has turned black

• Store at room temperature in a dark, dry place

• The Talent Converter with Xcelerant Hydro Delivery System is available in a variety of sizes. Please refer to

Section 17.0 for a complete listing of the available configurations

10.0 CLINICAL USE INFORMATION

CAUTION: Always have a vascular surgery team available during implantation or reintervention procedures in the

event that conversion to open surgical repair is necessary.

CAUTION: The Talent Converter Stent Graft System should only be used by physicians and teams trained in vascular interventional techniques. Additionally the Converter Stent Graft should only be used by those who have received both general Talent Abdominal Stent Graft System training and training in the use of this device. The recommended skill/knowledge requirements for physicians are outlined below:

10.1 Patient selection:

• Knowledge of the natural history of abdominal aortic aneurysms and comorbidities associated with abdominal repair

• Knowledge of image interpretation, stent graft selection and sizing

10.2 Physician skills and experience:

Either the individual physician operator or a combined, multidisciplinary team should possess extensive procedural skills and experience with:

• Femoral cutdown, arteriotomy, and repair

• Percutaneous access and closure techniques

• Non-selective and selective catheterization

• Live fluoroscopic and angiographic image interpretation

• Embolization

• Angioplasty

• Endovascular stent graft placement

• Snare techniques

• Appropriate use of contrast material

• Techniques to minimize radiation exposure

• Expertise in necessary patient follow-up modalities

• Reinstrumentation of pre-existing endovascular grafts

10.3 Materials Recommended for Device Implantation

At the time of surgery, it is recommended that physicians have available:

• At least one (1) additional set of Talent Converter Stent Graft (of the size intended for implantation) in the event that a device is contaminated or damaged during attempted placement

• Additional Talent Converter Stent Grafts (one [1] size larger and one [1] size smaller) in the event that the original measurement underestimated or overestimated vessel sizes

• Additional aortic and iliac extension cuffs of various lengths and diameters to customize the implant in order to fit the anatomy of the individual patient

• Fluoroscope - Freely-angled C-arm with digital angiography capabilities and the ability to record and recall imaging

• Contrast media

• Introducer sheaths to access arteries and to perform diagnostic imaging

• Assorted angiographic catheters, angioplasty catheters, graduated pigtail catheters

• Assorted guide wires

• Reliant® Stent Graft Balloon Catheter and other materials recommended by the Reliant Instructions

for Use

• Heparin and heparinized saline solution

• Radiopaque ruler with centimeter increments or radiopaque marker board

• Power injector and extension tubing

• Selection of 2-way and 3-way stopcocks

• Embolic coils

• Puncture needles

• Sterile markers (to mark skin, endovascular instruments or monitoring screen)

• Snare devices

• Surgical instruments and supplies

• Sterile saline ( for hydrophilic coating activation)

• Sterile gauze

• Talent Occluder

Intravascular ultrasound (IVUS) imaging equipment may also be useful if available, but only if the physician is experienced with its use. IVUS measurements performed at the time of treatment can provide supplementary data regarding vessel size.

The Reliant Stent Graft Balloon Catheter is packaged separately. This compliant balloon is used to assist in stent graft implantation by modeling the covered springs and to remove wrinkles and folds from the graft material. Sub-optimal expansion of self-expanding stent grafts may be improved by use of the Reliant Stent Graft Balloon Catheter.

NOTE: The Reliant Balloon is recommended for use with the Talent Converter Stent Graft. Data is not available for use with other balloons for remodeling stent grafts.

10.4 Converter Sizing Guidelines

Proper sizing of the device is the responsibility of the physician. The Converter Stent Graft can be placed either flush (proximal edges of the Talent Converter and bifurcated stent grafts at the same level) within the pre-existing Talent or AneuRx bifurcated stent graft or it can be placed proximal to the pre existing bifurcated stent graft (between 0 mm and 34 mm above the proximal fabric edge of the preexisting bifurcated stent graft).

When deploying a Converter Stent Graft flush within the pre existing bifurcated stent graft, refer to sizing guidelines in Table 2. When placing the Converter proximal to the pre existing bifurcated stent graft, refer to the sizing guidelines in Table 3

WARNING: Excessive oversizing of the Converter Stent Graft may lead to graft material infolding, which could result in patency issues.

NOTE: Vessel over-distension and damage may be caused by excessive oversizing of the stent graft in relation to the diameter of the blood vessel.

NOTE: Undersizing of the stent graft may lead to device migration and/or endoleaks.

Physicians may consult Medtronic Vascular for guidance in determining proper device dimensions based on the physician's assessment of the patient's anatomical measurements.

10.4.1 Converter Placed Flush W ithin The Pre-Existing Bifurcated Stent Graft Table 2 lists the sizing guidelines when the Talent Converter Stent Graft is deployed flush within the previously deployed Talent or AneuRx Bifurcated Stent Graft.

Table 2: Sizing guidelines for the Talent Converter Stent Graft deployed Flush within the Talent /AneuRx

Bifurcated Stent Grafts

Pre-existing Bifurcated graft catalog Number

Talent Converter to be placed flush within a Talent Bifurcated Stent Graft

AB2212C140 AB2212C155 AB2214C140 AB2214C155

Prox

Dia

(mm)

22 12, 14 140, 155

Dist

Dia

(mm)

Total

covered

length

(mm)

Recommended

Converter catalog

Number

CVB2216C126XH

Prox

Dia

(mm)

22 16 126

Dist

Dia

(mm)

Total

covered

length

(mm)

Pre-existing Bifurcated graft catalog Number

AF2412C140 AF2412C155 AF2412C170 AF2414C140 AF2414C155 AF2414C170

AF2612C140 AF2612C155 AF2612C170 AF2614C140 AF2614C155 AF2614C170 AF2616C140 AF2616C155 AF2616C170 AF2618C140 AF2618C155 AF2618C170

AF2814C140 AF2814C155 AF2814C170 AF2816C140 AF2816C155 AF2816C170 AF2818C140 AF2818C155 AF2818C170 AF2820C140 AF2820C155 AF2820C170

AF3014C140 AF3014C155 AF3014C170 AF3016C140 AF3016C155 AF3016C170 AF3018C140 AF3018C155 AF3018C170 AF3020C140 AF3020C155 AF3020C170

AF3214C155 AF3214C170 AF3216C155 AF3216C170 AF3218C155 AF3218C170 AF3220C155 AF3220C170

AF3416C155 AF3416C170 AF3418C155 AF3418C170

Prox

Dia

(mm)

24 12, 14

Dist

Dia

(mm)

12, 14,

16, 18

14, 16,

18, 20

14, 16,

18, 20

14, 16,

18, 20

16,

18, 20

Total

covered

length

(mm)

140, 155,

170

140, 155,

170

140, 155,

170

140, 155,

170

155, 170

Recommended

Converter catalog

Number

CVF2416C126XH

CVF2616C126XH

CVF2816C126XH

CVF3016C125XH

CVF3216C125XH

CVF3416C125XH

Prox

Dia

(mm)

24 16 126

26 16 126

28 16 126

30 16 125

32 16 125

34 16 125

Dist

Dia

(mm)

Total

covered

length

(mm)

Pre-existing Bifurcated graft catalog Number

AF3420C155 AF3420C170

AF3618C155 AF3618C170 AF3620C155 AF3620C170

Talent Converter to be placed flush within an AneuRx Bifurcated Stent Graft

BFXC2213135 BFXC2213165

BFXC2414135 BFXC2414165

BFXC2615135 BFXC2615165

BFXC2816135 BFXC2816165

10.4.2 Converter Placed Proximal To The Pre-Existing Bifurcated Stent Graft

Table 3 lists the sizing guidelines when the Converter Graft is deployed above the proximal edge of the previously deployed Talent or AneuRx Bifurcated Stent Graft. Oversizing of the Converter to the native vessel should be carried out as per the table below. These oversizing guidelines for the Talent converter are identical to the oversizing guidelines for the Talent bifurcated stent grafts.

Table 3: Talent Converter Stent Graft with Xcelerant HDS Sizing Guidelines

Prox

Dia

(mm)

36 18, 20 155, 170

22 13 135, 165

24 14 135, 165

26 15 135, 165

28 16 135, 165

Dist

Dia

(mm)

Total

covered

length

(mm)

Recommended

Converter catalog

Number

CVF3616C124XH

CVB2216C126XH

CVF2416C126XH

CVF2616C126XH

CVF2816C126XH

Prox

Dia

(mm)

36 16 124

22 16 126

24 16 126

26 16 126

28 16 126

Dist

Dia

(mm)

Total

covered

length

(mm)

Native Vessel Diameter

(mm)

18-19 22 20-21 24

22-23 26 24-25 28

26-27 30 28-29 32 30-31 34

32 36

Relevant materials should be readily available as listed in Section 10.3 - Cutdown, vessel access and vessel by-pass are required in all cases. A vascular surgical team should be readily available (i.e., within the same facility) in case of emergency conversion to an open surgical repair.

To reduce the risk of thromboembolism, it is recommended that patients are anticoagulated during the procedure, at the discretion of the physician.

If necessary, open narrow iliac vessels with standard Percutaneous Transluminal Angioplasty (PTA) catheters prior to Talent Converter Stent Graft with Xcelerant HDS placement (according to standard endovascular procedures). If necessary, dilate the vessel with a tapered vessel dilator. A step-up approach is recommended for vessel dilation.

Converter Graft -

Proximal Diameter

(mm)

11.0 DIRECTIONS FOR USE: TALENT CONVERTER STENT GRAFT WITH XCELERANT HDS

Prior to use of a Talent Converter with the Xcelerant Hydro Delivery System (HDS), review this Instructions for Use booklet. The following instructions embody a basic guideline for device placement. Variations in the following procedures may be necessary. These instructions are intended to help guide the physician and do not take the place of physician judgment.

General Use Information

Standard techniques for placement of arterial access sheaths, guiding catheters, angiographic catheters and guide wires should be employed during the use of a Talent Converter Stent Graft. The Talent Converter with the Xcelerant HDS is compatible with .035 inch diameter guide wires.

Pre-Implant Determinants

Correct sizing of the aorta and iliac vessels must be determined before implantation of the Talent Converter Stent Graft with Xcelerant HDS. Medtronic Vascular recommends using spiral computer aided tomography (CT) as well as angiograms of both the iliacs and aorta. These images should be available for review during the procedure. Verify from pre-implant imaging that the correct device has been selected. Determinants include:

1) Femoral artery selection for introduction of the delivery system.

2) Angulation of aortic neck, aneurysm and iliac arteries.

3) Quality of the aortic neck.

4) Diameters of infrarenal aortic neck and distal iliac arteries.

5) Distance from renal arteries to the proximal fabric edge of the pre-existing Talent or AneuRx Bifurcated stent

graft.

6) Consider the degree of vascular calcification and presence of thrombus.

Patient Preparation

1) Refer to hospital and physician preferred protocols relating to anesthesia, anticoagulation and monitoring of

vital signs.

2) Position patient on imaging table allowing fluoroscopic visualization from the aortic arch to the femoral

bifurcations.

3) Expose selected common femoral artery using standard surgical technique. When a femoral-to-femoral

crossover will be required as part of the procedure, both common femoral arteries should be exposed.

4) Establish adequate proximal and distal vascular control of selected femoral vessel.

11.1 Pictorial References

For pictorial references of the Talent Converter Stent Graft components with the Xcelerant HDS refer to Figure 1 and Figure 2 respectively.

11.2 Vascular Access and Arteriotomy

Following aseptic procedural guidelines perform arteriotomies at the access sites. Place a guide wire in the ipsilateral femoral artery and advance it above the renal arteries. From the contralateral side femoral artery, place a second guide wire directed to the abdominal aorta using surgical exposure or percutaneous approach. Over the guide wire, place an angiography catheter above the renal arteries.

11.3 Implantation of the Converter Stent Graft

11.3.1 Initial Angiogram

1) Place an angiographic flush catheter above the renal arteries and take an angiogram to

2) Be sure that the fluoroscope is angled perpendicularly to the center line of the infrarenal

11.3.2 Preparation of the Xcelerant HDS

1) Carefully inspect the sterile package and device for damage or defects before opening.

2) Do not use product after the “Use By” date on the package. If the integrity of the sterile

3) Flush the guide wire lumen with heparinized saline.

4) Before inserting the device into the vasculature, visualize the radiopaque markers on the

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

identify location of the renal arteries, location of the pre-existing stent graft and iliac artery birfurcation.

aorta to avoid parallax or other sources of visualization error. Align the target area/fixation zone (example, neck) in the center of the field.

package has been compromised or the packaging or product appears defective, do not use the product. Contact your Medtronic Vascular representative for return information.

Converter stent graft to identify positioning of the device within the sheath.

CAUTION: During general handling of the Xcelerant HDS, avoid bending or kinking the graft cover because it may cause the Talent Converter Stent Graft to prematurely and improperly deploy

NOTE: Prior to insertion, it is advisable to view the delivery system under fluoroscopy to visualize the radiopaque markers on the stent graft. The radiopaque markers indicate the location of the connecting bar and the edge of the graft material. Observe the position of the dot on the front grip of the Xcelerant HDS. This will serve as a reference for the orientation of the connecting bar.

11.3.3 Hydrophilic Coating Activation

1) Saturate sterile gauze in sterile saline.

2) Gently wipe the surface of the graft cover with saturated gauze until the graft cover is wet/slippery to touch.

NOTE: It is important to keep the graft cover surface wet/slippery to the touch during insertion of the delivery system. Once the hydrophilic coating on the delivery system is activated, the delivery system will be wet/slippery.

11.3.4 Introduction of the Delivery System

1) Advance the delivery system over the guide wire to the site of vascular access.

2) Align the connecting bar of the Talent Converter with the medial side of the ipsilateral limb of the previously deployed Talent or AneuRx bifurcated stent graft.

3) Slowly insert the Xcelerant HDS.

4) Advance the delivery system over the guide wire (see Figure 3). so that the most proximal spring of the stent graft and the radiopaque markers are visualized at the target location in the proximal aortic neck

Figure 3: Introduction of the Converter System

Previously placed Talent or AneuRx bifurcated stent graft

CAUTION: Never advance or retract the Xcelerant HDS from the vasculature without the use of fluoroscopy.

CAUTION: Do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guide wire 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.

CAUTION: Do not deploy the Talent Converter Stent Graft from the graft cover before placing it in the proper anatomical location. The Talent Converter Stent Graft cannot be reconstrained or drawn back into the graft cover, even if the stent graft is only partially deployed.

CAUTION: Before initial deployment, it is suggested to position the stent graft slightly higher than the targeted location.

11.3.5 Inject contrast media into the abdominal aorta and mark the position of the target location,

either on the imaging screen or with radiopaque marker or angiographic ruler on the patient’s body. Adjust the position of the stent graft such that the top edge of the graft fabric is at the intended landing site.

11.3.6 Confirm Position and Deploy Proximal End. See Figure 4 and Figure 5.

Figure 4: Position the system

NOTE: In cases of suprarenal fixation, ensure graft material is below both renal arteries. If the top

edge of the graft fabric is to be placed very close to the renal arteries, contrast media may be injected to identify the location of the lower renal artery and verify the position before fully deploying device. Once proximal position has been identified, do not move patient or imaging equipment. The angiographic catheter can be removed prior to deployment. However, if the angiographic catheter is not removed until after deployment, ensure that the tip is straightened (pigtail catheter) with a guide wire before removal so that the stent graft is not pulled down.

CAUTION: When aligning the position of the Xcelerant HDS so that the Talent Converter 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.

11.3.7 In order to deploy the proximal end of the stent graft, first hold the delivery system stationary

with one (1) hand on the front grip. Then, slowly withdraw the graft cover with the other hand by rotating the slider counter clockwise, until the proximal most spring has been fully deployed. Be sure to keep the delivery system as straight as possible

WARNING: Do not deploy the proximal fabric edge of the Talent Converter Stent Graft below the proximal-most fabric edge of the previously placed stent graft (including bifurs used in conjunction with aortic cuffs). This will avoid potential abrasion between the suprarenal stent of the Converter and the fabric of the previously placed stent graft which may lead to stent graft holes. Medtronic has been made aware of at least one instance from explant analysis of Talent stent grafts where putting a suprarenal stent inside the graft covered section of another device has resulted in graft material holes and broken sutures.

In the unlikely event of delivery system failure and concomitant partial stent graft deployment due to graft cover severance, a “handle dis-assembly” technique will permit successful deployment of the stent graft. See instructions at the end of this section for details of the technique.

Figure 5: Deploy Proximal End

11.3.8 Use angiography to verify the position of the stent graft in relation to the renal arteries.

11.3.9 If the position is too high, maintain the position of the slider and pull down on the entire

delivery system.

CAUTION: Care should be taken not to displace the pre-existing Talent or AneuRx bifurcated stent during placement of the Talent Converter.

CAUTION: Care should be taken not to damage or disturb the Converter stent graft position in the event that further manipulations of the Converter is required (for example, balloon modeling).

CAUTION: Do not reposition the Talent Converter if more than two (2) stent rings are deployed as this may result in premature or inaccurate deployment.

11.3.10 It is recommended that the physician rotate the slider until the first three (3) stents are

deployed. After that, the thumb may be used to pull the trigger on the slider back in order to more rapidly deploy the stent graft. See Figure 6.

CAUTION: 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.

Figure 6: Deploy the Distal End

CAUTION: If the graft cover is accidentally withdrawn, the device will prematurely deploy and be incorrectly positioned.

11.4 Deploy Distal End

11.4.1 While holding the delivery system stationary, withdraw the graft cover until the distal spring is

completely deployed.

CAUTION: Do not rotate the graft cover during deployment, as this may torque the device and cause it to spin or twist during deployment.

11.5 Delivery System Removal

11.5.1 Depress the Quick Disconnect and retract the tapered tip as shown in Figure 7. Use continual

fluoroscopy and watch the top of the Talent Converter Stent Graft while slowly pulling back the tapered tip into the graft cover of the Xcelerant HDS. This establishes a smooth transition between the tapered tip and the graft cover. To prevent the stent graft from being caught between the graft cover and tapered tip, ensure that the graft cover is fully retracted.

Figure 7: Use the Quick Disconnect to Retract the Tapered Tip

11.5.2 Gently remove the Xcelerant HDS. Do not use excessive force. Use fluoroscopy to ensure that the stent graft does not move during the withdrawal. See Figure 8.

NOTE: To prevent the stent graft from being caught between the graft cover and the tapered tip,

ensure that the graft cover is fully retracted. See Figure 8.

NOTE: Maintain vessel access and guide wire position until all components are placed.

Figure 8: Remove the Delivery System

11.6 Placement of the iliac extensions

In the event that an iliac extension is used, the mating sections are joined by aligning specific radiopaque markers. These radiopaque markers indicate the MINIMUM recommended overlap. The radiopaque markers used for mating are offset 30 mm from the end of the extension. The edges of the graft material and the connecting bar are indicated by the proximal and distal radiopaque markers. See Figure 9.

Figure 9: Iliac Extension

NOTE: Figure 9 is a graphical representation only. The grafts may appear differently when viewed

under fluoroscopy.

The iliac extensions are available in a variety of sizes. Please refer to Section 17.0 for a complete listing of the available configurations and refer to the Talent Abdominal Stent Graft with Xcelerant Hydro Delivery System Instructions for Use for oversizing guidelines.

NOTE: In cases where an iliac extension needs to be placed in a Talent Converter, measure the inner diameter of the intended landing zone within the Talent Converter Graft.

• If the inner diameter of the intended landing zone is ≤ 16 mm, size the proximal diameter of the iliac extension equivalent to the diameter of the landing zone

• If the intended landing zone is > 16 mm, do not oversize the proximal diameter of the iliac extension by more than 2 mm

11.7 Stent Graft Balloon Modeling

The Reliant Stent Graft Balloon Catheter can be used to assist in stent graft implantation by modeling the covered springs and to remove wrinkles and folds from the graft material, see Figure 10. Suboptimal expansion of the self-expanding stent graft(s) may also be improved by use of the Reliant Stent Graft Balloon. It is recommended that a backup balloon be available.

The following should be considered when using the Reliant balloon:

• 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

• Adhere to Reliant balloon inflation parameters as described in the Reliant Balloon Stent Graft Catheter Instructions for Use. Over-inflation may result in damage to the vessel wall and/or vessel rupture, or damage to the stent graft

• Recommended balloon inflation volumes should be strictly observed

• Confirm complete deflation of balloon prior to repositioning

Refer to the Instructions for Use supplied with the Reliant Stent Graft Balloon Catheter for more information.

NOTE: Care should be taken when inflating the balloon, especially with calcified, tortuous, stenotic, or otherwise diseased vessels.

Figure 10: Stent Graft Balloon Modeling

11.8 Occluder Placement

11.8.1 Use of the Talent Converter typically requires occlusion of the contralateral iliac artery in

conjunction with a standard femoral-femoral bypass procedure.

11.8.2 A Talent Occluder may be used to block retrograde blood flow into the aneurysm sac through

the common iliac artery. See Figure 11.

11.8.3 Follow the Talent Occluder with Occluder Delivery system Instructions for Use, for insertion

and procedural instructions.

NOTE: Medtronic recommends placement of the Talent Occluder in the native vessel and not within the pre-existing bifurcated device or extension.

Figure 11: Occluder Placement

11.9 Procedure Completion Final Angiogram

Converter Stent Graft for proximal and distal endoleaks and to verify the position of the implanted stent graft in relation to the aneurysm and renal arteries. Leaks at the attachment or connection sites should be treated by using the balloon to remodel the stent graft against the vessel wall. Major leaks that cannot be corrected by re-ballooning may be treated by adding Talent Stent Graft Extension Cuff(s) to the previously placed stent graft.

CAUTION: Any endoleaks left untreated during the implantation procedure must be carefully monitored after implantation. Additional procedures may be required in cases of persistent endoleaks.

11.10 Femoral-to-Femoral Crossover

Perform femoral-to-femoral crossover in standard surgical fashion to revascularize the contralateral limb.

11.11 Entry Site Closure

Repair the entry site with standard closure techniques. If during placement of the Talent Converter Stent Graft, the arteries used for access to the aorta are injured, additional endovascular and/or surgical procedures to repair the injury should be performed. If vascular repair becomes necessary, follow appropriate institutional guidelines, including guidelines regarding continuation or termination of the overall stent graft procedure.

11.12 Handle Dis-assembly Technique

In the unlikely event of delivery system failure and concomitant partial stent graft deployment due to graft cover severance, a “handle dis-assembly” technique will permit the successful deployment of the stent graft. See instructions below.

11.12.1 Pull back the trigger and fully retract the slider.

NOTE: Since the graft cover is severed, the slider can be retracted without further deploying the

stent graft.

11.12.2 Stabilize the Delivery System.

11.12.3 Insert the tips of a pair of hemostats into each one of the handle disassembly ports on the

front grip.

11.12.4 Disengage the front grip from the screw gear by pressing the tips of the hemostats into the

handle disassembly ports and simultaneously advancing the front grip away from the screw gear.

11.12.5 Advance the front grip until it fully clears the screw gear.

11.12.6 Separate the screw gear halves in order to identify the location of the graft cover severance.

11.12.7 Manually retract the graft cover with the fingers or with hemostats until the stent graft is fully

deployed.

11.12.8 Follow the standard instructions for delivery system removal. See Section 11.5.

: At the completion of the procedure, perform angiography to assess the Talent

12.0 IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP

12.1 General

The long-term performance of endovascular grafts with secondary endovascular intervention using additional components has not yet been established. All patients receiving the Talent Converter Stent Graft should receive enhanced follow-up.

All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft. Patients with specific clinical findings (for example, endoleaks, enlarging aneurysms, or changes in the structure or position of the endovascular graft) should receive additional follow-up. Patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter. Patients should be informed that regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of Abdominal Aortic Aneurysms. More frequent follow-up may be appropriate for all patients receiving the Talent Converter Stent Graft until stability of the Talent Converter Stent Graft, pre-existing Talent or AneuRx stent graft and aneurysm has been established.

The Talent Converter Stent Graft is not intended for primary endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms. It is intended for use in patients in whom a Talent or AneuRx stent graft has already been placed.

Due to the variety of failure modes of the AneuRx and Talent Stent Grafts, and considerable variability in anatomy and health status between patients, evaluation of the Talent Converter Stent Graft in every situation was not possible and the clinical outcome is unknown. The long term effect of the Talent Converter Stent Graft on the pre-existing Talent or AneuRx Stent Graft, or the effect of the pre-existing Talent or AneuRx Stent Graft on the Talent Converter Stent Graft is not known. Continued long-term monitoring of the Talent Converter Stent Graft and pre-existing Talent or AneuRx Stent Graft combinations through clinical and imagining follow-up is required after implantation.

Physicians should evaluate patients on an individual basis and prescribe follow-up relative to the needs and circumstances of each individual patient. The recommended imaging schedule is presented in Table 4. This schedule outlines the minimum requirement for patient follow-up and should be maintained even in the absence of clinical symptoms (for example, pain, numbness, weakness). Patients with specific clinical findings (for example, endoleaks, enlarging aneurysms, or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.

At a minimum, imaging follow-up should include abdominal radiographs and both contrast and non-contrast CT examinations and duplex ultrasounds or MRI. After secondary endovascular intervention, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular stent graft. If renal complications or other factors preclude the use of image contrast media, abdominal radiographs, non-contrast CT, and duplex ultrasound or MRI should be used.

• The combination of contrast and non-contrast CT imaging provides information on aneurysm

diameter change, endoleak, patency, tortuosity, progressive disease, fixation length and other morphological changes

• The abdominal radiographs provide information on device integrity (separation between

components and stent fracture)

• Duplex ultrasound imaging may provide information on aneurysm diameter change, endoleak,

patency, tortuosity and progressive disease. In this circumstance, a non-contrast CT may be performed to use in conjunction with the ultrasound, since ultrasound may be less reliable. Ultrasound may be a less reliable and sensitive diagnostic method compared to CT

Table 4: Recommended Imaging Schedule for Talent Converter Stent Graft Patients

Interval Angiogram

[Contrast & Non-Contrast]

Pre-procedure X1

Procedural X

1 Month X 3 Month X 6 Month X

12 Months (annually thereafter) X

Imaging should be performed within six (6) months before the procedure.

If renal complications or other factors preclude the use of image contrast media, abdominal radiographs,

non-contrast CT and duplex ultrasound or MRI should be used.

Either pre-discharge or 1 month CT recommended.

If a Type I or III endoleak is present, prompt intervention and additional follow-up post-intervention is

recommended. See Section13.0.

Recommended if endoleak reported at pre-discharge or 1 month or if the pre-existing graft is unstable.

2,3,4

2,4,5

2,4

Ultimately, it is the physician’s responsibility, based on previous clinical results and the overall clinical picture, to determine the appropriate imaging schedule for a particular patient.

12.2 Contrast And Non-Contrast CT Recommendations

• Film sets should include all sequential images at the lowest possible slice thickness (< 3 mm). Do

not perform large slice thickness (> 3 mm) and/or omit consecutive CT images/films sets, as this prevents precise anatomical and device comparisons over time

• All images should include a scale for each film/image. Images should be arranged no smaller than

20:1 images on 14 inch X 17 inch sheets if film is used

• Both non-contrast and contrast runs are required, with matching or corresponding table positions

• Pre-contrast and contrast run slice thicknesses and intervals must match

• DO NOT change patient orientation or re-landmark the patient between non-contrast and contrast

runs

Non-contrast and contrast enhanced baseline and follow-up imaging are important for optimal patient surveillance. It is important to follow accepted imaging protocols during the CT exam. Table 5 lists examples of accepted imaging protocols.

Table 5: Accepted Imaging Protocols

Abdominal

Radiographs

Non-Contrast Contrast

IV contrast No Yes Acceptable

machines

Injection volume N/A 150 cc

Injection rate N/A > 2.5cc/sec

Injection mode N/A Power

Bolus timing N/A

Coverage - start Diaphragm 1 cm superior to celiac axis

Coverage - finish Proximal femur Profunda femoris origin

Collimation < 3 mm < 3 mm

Reconstruction

Axial DFOV 32 cm 32 cm

Post-injection runs None None

12.3 Abdominal Radiographs

The following views are suggested:

• Four (4) films: supine-frontal (AP), cross-table lateral, 30 degree LPO and 30 degree RPO views

centered on the umbilicus

• Record the table-to-film distance and use the same distance at each subsequent examination

Ensure the entire device is captured on each single image (formatted lengthwise).

Spiral capable of > 40 seconds Spiral capable of > 40 seconds

Test bolus: SmartPrep, C.A.R.E. or

equivalent

2.5 mm throughout - soft algorithm

If there is any concern about the device integrity (for example, kinking, stent breaks, migration), it is recommended to use magnified views. The attending physician should evaluate films for device integrity (entire device length including components) using a 2-4X magnification visual aid.

12.4 Ultrasound

Ultrasound imaging may be performed in place of contrast CT when patient factors preclude the use of image contrast media. In order to help support accurate evaluation, ultrasound images should be paired with non-contrast CT images. A complete aortic duplex should be videotaped and analyzed for maximum aneurysm diameter, endoleaks, stent patency and stenosis. Included on the videotape should be the following information as outlined below:

• Transverse and longitudinal imaging should be obtained from the level of the proximal aorta, including complete imagery from the mesenteric and renal arteries to the iliac bifurcations to determine if endoleaks are present. Utilize color flow and color power angiography (if available)

• Spectral analysis confirmation should be performed for any suspected endoleaks

• Transverse and longitudinal imaging of the maximum aneurysm should be obtained

12.5 MRI Safety and Compatibility

Non-clinical testing has demonstrated that the Talent Converter Stent Graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under the following conditions:

12.5.1 Talent Converter deployed in a Talent Bifurcated Stent Graft

1.5 Tesla Systems:

• Static magnetic field of 1.5 Tesla

• Spatial gradient field of 1000 Gauss/cm

• Maximum whole-body-averaged specific absorption rate (SAR) of 4W/kg for fifteen (15)

minutes of scanning

• Patients with Talent Converter Stent Grafts implanted in the abdominal aorta may safely

undergo MRI for Normal Mode and First Level Controlled Operating Mode of the MR System, as defined in IEC Standard 60601-2-33

Based on non-clinical testing, the device was determined to produce a temperature rise of less than 1°C at a maximum whole body averaged specific absorption rate (SAR) of 4 W/kg for fifteen (15) minutes of MR scanning in a 64MHz whole body transmit coil, which corresponds to a static field of

1.5T. The maximum whole body averaged specific absorption rate (SAR) was derived by calculation and verified by calorimetry.

3.0 Tesla Systems:

• Static magnetic field of 3.0 Tesla

• Spatial gradient field of 1000 Gauss/cm

• Maximum whole-body-averaged specific absorption rate (SAR) of 4W/kg for fifteen (15)

minutes of scanning (or the maximum SAR allowed by the MR System, whatever is less)

• Patients with Talent Converter Stent Grafts implanted in the abdominal aorta may safely

undergo MRI for Normal Mode and First Level Controlled Operating Mode of the MR System, as defined in IEC Standard 60601-2-33

Based on non-clinical testing, the device was determined to produce a temperature rise of less than 1°C at a maximum whole body averaged specific absorption rate (SAR) of 4 W/kg for fifteen (15) minutes of MR scanning in a 3 Tesla Siemens TrioTIM (VB 13 Software) MR scanner. The maximum whole body averaged specific absorption rate (SAR) was derived by calculation and verified by calorimetry.

Image Artifact (1.5 Tesla & 3 Tesla Systems):

MR image quality may be compromised if the area of interest is in the same area as the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant. The image artifact extends approximately 5 and 8 mm from the device, both inside and outside the device lumen when scanned in non-clinical testing using the sequence: spin echo and gradient echo, respectively in a 3.0T Siemens TrioTIM (VB 13 Software) MR system with a whole body coil.

12.5.2 Talent Converter deployed in an AneuRx Bifurcated Stent Graft

1.5 Tesla Systems:

• Static magnetic field of 1.5 Tesla

• Spatial gradient field of 1000 Gauss/cm

• Maximum whole-body-averaged specific absorption rate (SAR) of 4W/kg for fifteen (15)

minutes of scanning

• Patients with Talent Converter Stent Grafts implanted in the abdominal aorta may safely

undergo MRI for Normal Mode and First Level Controlled Operating Mode of the MR System, as defined in IEC Standard 60601-2-33

1.5T. The maximum whole body averaged specific absorption rate (SAR) was derived by calculation and verified by calorimetry.

3.0 Tesla Systems:

• Static magnetic field of 3.0 Tesla

• Spatial gradient field of 1000 Gauss/cm

• Maximum whole-body-averaged specific absorption rate (SAR) of 4W/kg for fifteen (15)

minutes of scanning (or the maximum SAR allowed by the MR System, whatever is less)

• Patients with Talent Converter Stent Grafts implanted in the abdominal aorta may safely

undergo MRI for Normal Mode and First Level Controlled Operating Mode of the MR System, as defined in IEC Standard 60601-2-33

Based on non-clinical testing, the device was determined to produce a temperature rise of less than 1°C at a maximum whole body averaged specific absorption rate (SAR) of 4 W/kg for fifteen (15) minutes of MR scanning in a 3 Tesla GE Signa HDx MR scanner. The maximum whole body averaged specific absorption rate (SAR) was derived by calculation and verified by calorimetry.

Image Artifact (1.5 Tesla & 3 Tesla Systems):

MR image quality may be compromised if the area of interest is in the same area as the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant. Image distortion as great as 20 mm beyond the AneuRx may occur. The addition of the Converter does not result in additional image distortion for AneuRx. Distortion is less than 7 mm for a Converter that extends beyond the body of an AneuRx bifurcated stent graft.

13.0 ADDITIONAL SURVEILLANCE AND TREATMENT

Additional surveillance and possible treatment is recommended for:

• Aneurysms with endoleak

• Aneurysm enlargement > 5 mm in maximum diameter (regardless of endoleak status)

• Migration

• Inadequate seal length

• Fracture

• Separation from pre-existing graft

• Pre-existing graft is unstable

Consideration for reintervention or conversion to open repair should include the attending physician's assessment of an individual patient's co-morbidities, life expectancy, and the patient's personal choices. Patients should be counseled that subsequent re-intervention, including the fact that catheter-based or open surgical conversion may become necessary following an endograft procedure.

14.0 POST APPROVAL REGISTRY

A registry designed to collect information specific to physician experience with the Talent Converter Stent Graft System is required by the FDA. Physicians are strongly requested and highly encouraged to participate in this registry. Analysis of registry data may identify factors affecting patient outcome. For more information about the Talent Converter Stent Graft, please go to the Medtronic website (www.medtronic.com).

15.0 DEVICE – RELATED ADVERSE EVENTS REPORTING

Any adverse event (clinical incident) involving the Talent Converter Stent Graft System should be reported to Medtronic Vascular immediately. To report an incident, call (800) 465-5533 (in the US).

16.0 DEVICE REGISTRATION PACKET

The Talent Converter Stent Graft System is packaged with additional specific information which includes:

• Temporary Device Identification Card: It includes both patient and stent graft information. Physicians should complete this card and instruct the patient to keep this card in their possession at all times. The patients should refer to this card anytime they visit additional health practitioners, particularly for any additional diagnostic procedures (for example, MRI). This temporary identification card should only be discarded when the permanent identification card is received

• Device Tracking Form purposes of tracking all patients who received a Talent Converter Stent Graft (as required by Federal Regulation). The hospital’s submission of the device tracking form to Medtronic is also required for a patient to receive the permanent identification card

Upon receipt of the device tracking form, Medtronic will mail the patient a permanent device identification card. This card includes important information regarding the implanted stent graft. Patients should refer to this card anytime they visit health practitioners, particularly for any diagnostic procedures (for example, MRI). Patients should carry this card with them at all times. If a patient does not receive their permanent device identification card, or requires changes to the card, call 1-800-551-5544.

: This form should be completed by the hospital staff and forwarded to Medtronic for the

17.0 CONFIGURATIONS AVAILABLE

Figure 12: Overview of Talent Converter Stent Graft

FreeFlo Configuration Shown

[22 mm size has Bare Spring configuration

without mini-support spring (not shown in

the figure)]

Closed Web

Configuration

22-36 mm

124-126 mm

Table 6: Converter Stent Grafts with the Xcelerant Hydro Delivery System

(Fr.)

The delivery system working length is 52 cm.

Diameter,

Prox. x Dist.

(mm x mm)

36 x16 124 34 x16 32 x16

30 x16

28 x16 126

26 x16 126 24 x16 126

22 x16 126

Covered

length (mm)

125

16 mm

Total

Length

(mm)

140

Proximal

Configuration

FreeFlo

Bare Spring

Distal

Configuration

Closed Web

Table 7: Iliac Extensions with the Xcelerant Hydro Delivery System

(Fr.)

Iliac

Extension

(mm x mm)

22x22 79

22x18 74

18x24 18x22

18x18 18x16 18x14 18x12

20x16 74

20x20 79

Covered

Length

(mm)

140

Proximal

Configuration

Distal

Configuration

18x20 18x18 18x16

18x14 75

The delivery system working length is 52 cm. The total length of the stent graft can be determined by adding approximately 15 mm to the covered length shown above.

18x12

16x16

16x12 75

14x14 80

14x10 75

12x12 81

12x08 75

10x10 81

Open Web Closed Web

18.0 EXPLANATION OF SYMBOLS

Explanation of symbols that may appear on product labeling.

Contents: One (1) TALENT Abdominal Stent Graft System with Xcelerant HDS and

One (1) Device Registration Packet

Consult instructions for use at.

Do not use if package is damaged

Non-pyrogenic

Peel here

Do not reuse

www.medtronic.com/manuals

Store at room temperature in a dark, dry place

MR Conditional

CAUTION: Federal (USA) law restricts this device for sale by or on order of a physician.

Sterilized using irradiation

Do not use if indicator turns black

MANUFACTURER:

MEDTRONIC, INC. 710 Medtronic Parkway NE Minneapolis, MN 55432-5604 U.S.A. Tel: (763) 514-4000 Fax: (763) 514-4879

www.medtronic.com

U. S. CUSTOMER SERVICE / PRODUCT INQUIRIES

Tel: (800) 961-9055 Fax: (800) 929-2133

Protected by one (1) or more of the following United States patents: 5,591,195; 5,713,917; 6,306,141; 6,344,052; 6,911,039; and 7,105,016.

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