Medtronic OCL10US Instructions for Use

Talent™ Occluder with Occluder Delivery System

Instructions for Use

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

© 2018 Medtronic. All rights reserved. Medtronic and Medtronic logo are trademarks of Medtronic. ™* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

EXPLANATION OF SYMBOLS

Explanation of symbols that may appear on product labeling.

Contents: One (1) TALENT ABDOMINAL OCCLUDER System and One (1) Device Registration Packet

Do not reuse

Manufacturer

Catalogue number

Lot number

Serial number

Use by

Do not use if package is damaged

Non-pyrogenic

Peel here

Store at room temperature in a dark, dry place

MR Conditional

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Sterilized using ethylene oxide

Consult instructions for use at: www.medtronic.com/manuals

Talent™ Occluder with Occluder Delivery System

Table of contents

1. Device description .................................................................................................................................................................................................................................................. 2

2. Indications ............................................................................................................................................................................................................................................................... 3

3. Contraindications ................................................................................................................................................................................................................................................... 3

4. Warnings and precautions ..................................................................................................................................................................................................................................... 3

4.1. General .......................................................................................................................................................................................................................................................... 3

4.2. Patient selection ............................................................................................................................................................................................................................................ 4

4.3. Implant procedure .......................................................................................................................................................................................................................................... 4

4.4. Magnetic resonance imaging (MRI) safety section ........................................................................................................................................................................................ 4

5. Adverse events ....................................................................................................................................................................................................................................................... 4

5.1. Observed adverse events .............................................................................................................................................................................................................................. 4

5.2. Potential adverse events ............................................................................................................................................................................................................................... 5

5.3. Device-related adverse events reporting ....................................................................................................................................................................................................... 5

6. Patient selection ..................................................................................................................................................................................................................................................... 5

6.1. Individualization of treatment ......................................................................................................................................................................................................................... 5

7. Patient counseling information ............................................................................................................................................................................................................................. 5

8. How supplied .......................................................................................................................................................................................................................................................... 6

9. Clinical use information ......................................................................................................................................................................................................................................... 6

9.1. Patient selection ............................................................................................................................................................................................................................................ 6

9.2. Physician skills and experience ..................................................................................................................................................................................................................... 6

9.3. Materials recommended for device Implantation ........................................................................................................................................................................................... 6

9.4. Sizing guidelines ............................................................................................................................................................................................................................................ 6

10. Directions for use – Talent occluder ..................................................................................................................................................................................................................... 7

10.1. Talent occluder deployment ........................................................................................................................................................................................................................... 7

11. Imaging guidelines and post-operative follow-up ............................................................................................................................................................................................. 10

11.1. General ........................................................................................................................................................................................................................................................ 10

11.2. Contrast and non-contrast CT recommendations ........................................................................................................................................................................................ 10

11.3. Abdominal/iliac radiographs ......................................................................................................................................................................................................................... 10

11.4. Ultrasound .................................................................................................................................................................................................................................................... 11

11.5. MRI safety and compatibility ......................................................................................................................................................................................................................... 11

12. Additional surveillance and treatment ................................................................................................................................................................................................................. 11

13. Device-related adverse events reporting ............................................................................................................................................................................................................ 11

14. Device registration packet .................................................................................................................................................................................................................................... 11

15. Configurations available ....................................................................................................................................................................................................................................... 11

Important!

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Do not attempt to use the Talent occluder with occluder delivery system before completely reading and understanding the information contained in this booklet.

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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.

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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.

1. Device description

The Talent™ occluder with occluder delivery system comprises 2 main components: an implantable occluder and a disposable delivery system. The pre-loaded occluder is advanced to the desired location within the iliac artery and upon retraction of an introducer sheath, expands to the indicated diameter. During deployment and expansion, the occluder is intended to conform to the shape and size of the iliac artery.

The Talent occluder is closed at both ends in order to stop retrograde blood flow into the aneurysm sac. This component is used in conjunction with a fem-fem bypass. The occluder is comprised of nitinol metal springs attached to polyester fabric graft material. The springs are sewn to the polyester fabric graft using polyester suture material. A

Platinum-iridium Figur8 radiopaque marker is sewn onto the occluder to aid in visualization of the occluder under fluoroscopy and to facilitate accurate placement of the device. See Figure 1.

The occluder is designed to be placed in the native vessel such that the occluder’s deployed diameter is larger than the diameter of the native vessel. This “oversizing” helps to ensure that the occluder is held in place preventing retrograde blood flow into the aneurysm sac. The amount of oversizing required is dependent on the diameter of the native vessel. See Section 15 for the sizes available and Table 2 for Oversizing Guidelines.

Table 1. Occluder materials

Springs Nitinol wire

Occluder

Stent fabric Woven polyester Sutures Braided polyester suture Figur8 radiopaque markers Platinum-iridium wire

component Material

2 Instructions for Use English

Figure 1. Talent occluder

7 8

1. 31-35 mm

2. 8-24 mm

3. Figur8 radiopaque marker

The Occluder Delivery System (Figure 2) consists of a dilator used for delivery system insertion, a cartridge preloaded with the occluder, an introducer sheath for delivering the occluder to the target location, and a pushrod to advance and deploy the occluder. It is a single use, disposable system.

Figure 2. Occluder delivery system

1. Tapered tip of the dilator

2. Blunted tip of the pushrod

3. Tapered tip of the introducer sheath

4. Sideport extension

5. Stopcock

6. Introducer sheath

7. Introducer sheath hub

8. Hemostasis valve

9. Luer handle (identical for dilator and pushrod)

10. Cartridge with pre-loaded occluder

2. Indications

The Talent occluder with occluder delivery system is intended for endoluminal occlusion of the common iliac artery in order to prevent retrograde blood into the aneurysm sac when used in conjunction with a fem-fem bypass (for example, the Talent occluder can be used in combination with the Endurant II AUI stent graft). The anatomical considerations are as follows:

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Iliac/femoral access vessel morphology that is compatible with vascular access techniques and a delivery system profile of 5.8 mm (17.5 Fr).

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Common iliac vessel diameters between 6 mm and 20 mm

3. Contraindications

The Talent occluder is contraindicated in:

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Patients who have a condition that threatens to infect the occluder

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Patients with sensitivities or allergies to the device materials (see Table 1: Occluder materials)

4. Warnings and precautions

4.1. General

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Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient

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When the Talent occluder is used in patients with other endovascular stent grafts, also refer to the instructions for use of that specific endovascular stent graft for additional information.

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The Talent occluder with occluder delivery system should only be used by physicians and teams trained in vascular interventional techniques and in the use of the device. Specific training expectations are described in Section 9

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

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Monitoring of the Talent occluder through clinical and imaging follow-up is required after implantation of the Talent occluder for the following reasons:

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all endovascular devices require follow-up to ensure continued success of the treatment over time

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a variety of endovascular device failure modes and considerable variability in anatomy and health status between patients precluded evaluation of the Talent occluder in every possible clinical situation to determine patient outcome

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The long-term performance of the Talent occluder has not yet been established. All patients receiving the Talent occluder should receive enhanced follow-up. Specific follow-up guidelines are described in Section 11

Instructions for Use English 3

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All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their Talent occluder. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms or changes in the position of the occluder) should receive enhanced follow-up. Specific follow-up guidelines are described in Section 11

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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 occluder until stability of the Talent occluder and aneurysm has been established

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After endovascular intervention, patients should be regularly monitored for perigraft flow (endoleaks), aneurysm growth or changes in the position of the Talent occluder. At a minimum, imaging should include: 1) abdominal/iliac radiographs to examine device integrity (stent fracture) and 2) contrast and non-contrast CT to examine aneurysm changes, perigraft flow, 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

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

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Patients experiencing leaks may be required to undergo secondary interventions or surgical procedures

4.2. Patient selection

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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

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

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Occluder placement is recommended in patients with access vessel diameter and morphology (minimal tortuosity, occlusive disease and/or calcification) compatible with vascular access techniques and a delivery system profile of 5.8 mm (17.5 Fr). Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the occluder and/or may increase the risk of embolization

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Prior to the procedure, pre-operative planning for access and placement should be performed (see Section 9.4)

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The Talent occluder is not recommended in patients who:

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Cannot tolerate contrast agents necessary for imaging

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Will not be compliant with the necessary preoperative, intra-operative and postoperative imaging and implantation studies as described in Section 11

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Exceed weight and/or size limits which compromise or prevent the necessary imaging requirements

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Inappropriate patient selection may contribute to poor device performance

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The safety and effectiveness of the Talent occluder with occluder delivery system has not been evaluated in patients who:

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Are less than 18 years of age

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Are pregnant or lactating

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Have vessels and/or aneurysm dimensions that cannot accommodate the Talent occluder as per the indications in Section 9.4

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Have contraindications for use of contrast medium or anticoagulation drugs

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Have an uncorrectable coagulopathy

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Have a mycotic aneurysm

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Have had a recent (within 3 months) myocardial infarction (MI), cerebral vascular accident (CVA), or major surgical intervention

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Have traumatic aortic injury

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Have genetic connective tissue disease (e.g., Marfan's or Ehlers-Danlos' Syndromes)

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Have active systemic infections

4.3. Implant procedure

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

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The use of a Talent occluder 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

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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

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

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Maintain guide wire position during delivery system introducer sheath and dilator insertion

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Improper placement of the occluder may cause an endoleak, migration, or unintended occlusion of a side branch vessel thus necessitating additional interventional procedures

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Medtronic recommends placement of the Talent occluder in the native vessel and not within a pre-existing stent graft

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Take care during manipulation of catheters, wires and sheaths. Significant disturbances may dislodge fragments of thrombus, which can cause distal embolization

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During advancement of the delivery system, ensure that the guide wire and the delivery system do not damage or disturb a pre-existing stent graft

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Never advance or retract the occluder delivery system from the vasculature without the use of fluoroscopy

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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

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The Talent occluder cannot be reconstrained or drawn back into the introducer sheath, even if the occluder is only partially deployed. If the introducer sheath is accidentally withdrawn, the device will prematurely deploy and could be placed too high or too low

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High pressure injections of contrast media made at the edges of the occluder immediately after implantation can cause endoleaks

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

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

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Pre-operative planning for access and placement should be performed before opening the device package as described in Section 9.4

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Carefully inspect the Talent occluder with occluder delivery system packaging for damage or defects prior to use. Do not use product if any sign of damage is observed. Do not attempt to re-sterilize the Talent occluder component or the occluder delivery system

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Renal complications may occur:

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From an excess use of contrast agents

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As a result of emboli

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Inadequate sealing with the vessel wall may result in increased risk of leakage into the aneurysm or migration of the occluder

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Inserting the dilator at an angle could dislodge the hemostasis valve

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Inserting the cartridge or push rod at an angle could dislodge the hemostasis valve

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Do not use high pressure injectors in conjunction with the occluder

4.4. Magnetic resonance imaging (MRI) safety section

Non-clinical testing has demonstrated that the Talent occluder 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 11.5.

5. Adverse events

5.1. Observed adverse events

Medtronic Vascular conducted 2 studies (Endurant AUI IDE study and Talent Converter Post-Market Approval study) where the Talent occluder device was used on physician's discretion subsequent to fem-fem bypass in conjunction with a pre-existing stent graft in 19 out of the 64 patients. No adverse events related to the Talent occluder system have been reported.

4 Instructions for Use English

5.2. Potential adverse events

Adverse events which may be associated with the use of the Talent occluder used in conjunction with a fem-fem bypass, the implant procedure, or the attendant equipment and supplies are similar to those associated with conventional open surgical repair of AAA. Potential adverse events/complications and outcomes that can be associated with the use of the Talent occluder system include, but are not limited to:

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Amputation

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Anesthetic complications and subsequent attendant problems (e.g., aspiration)

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Aneurysm enlargement

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Aneurysm rupture and death

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

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Arterial or venous thrombosis and/or pseudoaneurysm

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Bleeding, hematoma or coagulopathy

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Bowel complications (e.g., ileus, transient ischemia, infarction, necrosis)

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Cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension)

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Claudication (e.g., buttock, lower limb)

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Damage or dislodgement of pre-existing graft

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Death

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Edema

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

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Endoleak

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Fever and localized inflammation

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

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Genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, fistula, incontinence, hematuria, infection)

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Hepatic failure

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Impotence

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Infection of the aneurysm, device access site, including abscess formation, transient fever and pain

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Lymphatic complications and subsequent attendant problems (e.g., lymph fistula)

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Neurologic local or systemic complications and subsequent attendant problems (e.g., confusion, stroke, transient ischemic attack, paraplegia, paraparesis, paralysis)

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Inadvertent occlusion of vessel

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Pulmonary/respiratory complications and subsequent attendant problems (e.g., pneumonia, respiratory failure, prolonged intubation)

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Renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure)

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Improper component placement; incomplete component deployment; component migration; suture break; occlusion of unintended artery; infection; stent fracture; insertion and removal difficulties; material wear; dilatation; erosion; puncture perigraft flow and corrosion

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Surgical conversion to open repair

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Vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, dissection

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Vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death)

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Vessel damage

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Wound complications and subsequent attendant problems (e.g., dehiscence, infection, hematoma, seroma, cellulitis)

5.3. Device-related adverse events reporting

Any adverse event (clinical incident) involving the Talent occluder with the occluder delivery system should be reported to Medtronic Vascular immediately. To report an incident, call (800) 465-5533 (in the US).

6. Patient selection

(see warnings and precautions)

6.1. Individualization of treatment

Medtronic recommends that the Talent occluder diameters be selected as described in Table 5. 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 intraoperative flexibility to achieve optimal procedural outcomes. The warnings and precautions previously described in Section 4. Additional considerations for patient selection include, but are not limited to:

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Patient's age and life expectancy

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Co-morbidities (e.g., cardiac, pulmonary or renal insufficiency prior to surgery, morbid obesity)

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Patient's suitability for open surgical repair

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Patient's anatomical suitability for endovascular repair

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Ability to tolerate general, regional or local anesthesia

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Iliofemoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity) should be compatible with vascular access techniques for a 17.5 French delivery catheter profile

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Use of the Talent occluder is recommended in patients with common iliac vessel diameters between 6 mm and 20 mm

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The Talent occluder is Contraindicated in:

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Patients who have a condition that threatens to infect the occluder

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

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

7. 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:

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Risks and differences between endovascular repair and surgical repair

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Potential advantages of open surgical repair

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Potential advantages of endovascular repair

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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 as to expectations after an endovascular repair:

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The long-term performance of endovascular repair has not yet been established. All patients receiving the Talent occluder should receive enhanced follow-up. Specific followup guidelines are described in Section 11, Imaging Guidelines and Post- Operative Follow-Up

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All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of the occluder. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms or changes in the position of the occluder) should receive enhanced follow-up. Specific follow-up guidelines are described in Section 11 Imaging Guidelines and Post-Operative Follow-Up

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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 follow-up requirements is required and should be considered a lifelong commitment to the patient’s health and well-being

Instructions for Use English 5

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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 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

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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).

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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 (e.g., MRI)

8. How supplied

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The Talent occluder is supplied sterile and is intended for single use only. Delivery systems are disposable; do not reuse. Never attempt to resterilize a Talent occluder. Resterilization may adversely affect the proper mechanical function of the device and could result in patient injury and/or conversion to an open surgical procedure

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In addition to the device, each carton contains 1 set of patient tracking materials

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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

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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

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Do not use after the “USE BY” (expiration) date printed on the label

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Store at room temperature in a dark, dry place

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The Talent occluder is available in a variety of sizes. Please refer to Section 15 for a complete listing of the available configurations

9. Clinical use information

Caution: Always have a vascular surgery team available during implantation procedures in the event that conversion to open surgical repair is necessary. Caution: The Talent occluder system should only be used by physicians and teams trained in vascular interventional techniques.

The recommended skill/knowledge requirements for physicians are outlined below:

9.1. Patient selection

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

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Knowledge of image interpretation and device sizing

9.2. Physician skills and experience

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

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Femoral cut-down, arteriotomy, and repair

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Percutaneous access and closure techniques

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Non-selective and selective catheterization

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Live fluoroscopic and angiographic image interpretation

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Embolization

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Angioplasty

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Endovascular stent graft and occluder placement

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Endovascular occlusion techniques

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Appropriate use of contrast material

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Techniques to minimize radiation exposure

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Expertise in necessary patient follow-up modalities

9.3. Materials recommended for device Implantation

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

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At least 1 additional Talent occluder (of the size intended for implantation) in the event that the device is contaminated or damaged during attempted placement

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Additional Talent occluders (1 size larger and 1 size smaller) in the event that the original measurement underestimated or overestimated vessel sizes

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

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Contrast media

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Introducer sheaths to access arteries and to perform diagnostic imaging

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Assorted angiographic catheters, angioplasty catheters, graduated pigtail catheters

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Assorted guide wires

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Heparin and heparinized saline solution

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Selection of 2-way and 3-way stopcocks

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Embolic coils

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Puncture needles

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

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Surgical instruments and supplies

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Sterile gauze

9.4. Sizing guidelines

Correct sizing of the iliac vessels must be determined before implantation of the Talent occluder with the occluder delivery system. Medtronic recommends using spiral computer aided tomography (CT) as well as angiograms of both the iliacs. These images should be available for review during the procedure.

Each Talent occluder system must be ordered in a size appropriate to fit the patient's anatomy. Sizing must be to the vessel wall, not thrombus. Proper sizing of the device is the responsibility of the physician. See the recommended oversizing guidelines in Table 2.

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Vessel over-distension and damage may be caused by excessive oversizing of the occluder in relation to the diameter of the blood vessel

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Undersizing of the occluder 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.

Table 2. Talent occluder oversizing guidelines

vessel diameter (mm) Recommended occluder diameter (mm)

Native

6 8

7 to 8 10

9 to 10 12

11 to 12 14

13 16 14 to 15 18 16 to 17 20

6 Instructions for Use English

Native vessel diameter (mm) Recommended occluder diameter (mm)

Relevant materials should be readily available as listed in Section 9.3. A vascular surgical team should be readily available (i.e., within the same facility) in case of emergency surgical vascular 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 occluder with occluder delivery system 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.

18 22 19 to 20 24

10. Directions for use – Talent occluder

Prior to use of a Talent occluder with occluder delivery system, 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, angiographic catheters and guide wires should be employed during use of a Talent occluder. The Talent occluder delivery system is compatible with .035 inch diameter guide wires.

Pre-implant determinants

Correct sizing of the iliac vessels must be determined before implantation of the Talent occluder. Medtronic Vascular recommends using spiral computer aided tomography (CT) as well as angiograms of the iliac artery. 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. Diameter of iliac artery target site (6 mm to 20 mm)

3. Degree of vascular calcification and presence of thrombus

Caution: Medtronic recommends placement of the Talent occluder in the native vessel and not within a pre-existing stent graft.

Patient preparation

1. Refer to hospital and physician preferred protocols relating to anesthesia, anticoagulation and monitoring of vital signs.

2. Perform an arteriotomy at the intended access site following aseptic procedural guidelines in order to obtain vascular access.

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

4. Place a 0.035” guide wire in the femoral artery and advance it above the target location. Warning: Advance the guide wire carefully to ensure the pre-existing stent graft does not get damaged or displaced.

5. Take an angiogram to visualize the iliac. This angiogram may be used as a reference for the implantation procedure.

10.1. Talent occluder deployment

Medtronic recommends the following steps for deploying the Talent occluder:

1. Carefully inspect the sterile package and product for damage or defects before opening. If the integrity of the sterile package has been compromised or the packaging or product appears defective, do not use the product. Contact your Medtronic Vascular representative for return information. Do not use product after the “Use By” date on the package.

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

2. 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.

3. Use the stopcock to flush the introducer sheath with heparinized saline solution, and then close the stopcock valve.

4. Flush the dilator and wet the outer surface of the dilator with heparinized saline solution.

5. Insert the dilator through the center of the introducer sheath valve until the dilator handle comes in contact with the introducer sheath hub. Caution: Inserting the dilator at an angle could dislodge the hemostasis valve.

6. Submerge the pre-loaded occluder cartridge in heparinized saline solution.

7. Insert the dilator/introducer sheath assembly over the guide wire and slowly advance it over the wire to the common iliac – above the intended landing zone but below the distal aorta or aneurysm sac.

Warning: During advancement of the delivery system, ensure that the guide wire and the delivery system do not damage or disturb a pre-existing stent graft. Caution: Ensure that the dilator does not retract during advancement of the system to ensure smooth transition between the introducer sheath tip and the dilator.

8. Remove the guide wire. Once the guide wire has been removed, remove the dilator.

9. Wet the outer surface of the push rod with heparinized saline solution.

10. Insert the smaller end of the occluder cartridge into the hemostasis valve of the introducer sheath. Ensure the cartridge lip comes in contact with the introducer handle. Allow blood to drip out of the back end of the cartridge before inserting the pushrod. Hemostasis may be maintained with the fingers while the pushrod is inserted. See Figure 3 below.

Caution: Inserting the cartridge or push rod at an angle could dislodge the hemostasis valve.

Instructions for Use English 7

Figure 3. Insertion of cartridge

Caution: Do not use the dilator to advance the occluder through the system.

11. Use the pushrod to advance the occluder fully into the introducer sheath. See Figure 4 below.

Figure 4. Advancing the occluder into the introducer sheath

12. Remove the cartridge and the pushrod together from the introducer sheath, see Figure 5 below.

8 Instructions for Use English

Figure 5. Removing the pushrod and cartridge

13. Remove the empty cartridge from the pushrod.

14. Re-insert the pushrod and carefully advance the occluder under fluoroscopic guidance until it is near the tip of the introducer sheath. Note that the radiopaque marker on the distal end of the occluder should be approximately one occluder body length from the tip of the introducer sheath. Refer to Table 5 for occluder lengths.

15. Verify that the occluder within the introducer sheath is properly positioned at the intended landing zone using fluoroscopy. Adjust the introducer sheath location as necessary. Caution: When aligning the position of the introducer sheath so that the occluder implant is in the proper position for deployment within the iliac artery, be sure that the

fluoroscope is angled optimally to avoid parallax or other sources of visualization error.

16. Deploy the occluder by holding the pushrod stationary and slowly withdrawing the introducer sheath.

17. Verify that the occluder implant has deployed and expanded. See Figure 6.

18. Carefully remove the introducer sheath and pushrod.

19. Take an angiogram to verify proper occluder placement and that there is no endoleak around the occluder. Caution: Do not use high pressure injectors in conjunction with the occluder.

20. A minor endoleak may seal spontaneously within several days. Any endoleak left untreated during the initial implantation procedure must be carefully followed post-implantation. Additional secondary procedures may be required to treat persistent endoleaks or incomplete occlusion of the targeted vessel.

21. Repair the entry site with standard closure technique.

1. Aortic aneurysm

2. Iliac aneurysms

3. Al common iliac

4. Occluder marker band

Figure 6. Occluder deployed

Instructions for Use English 9

5. External iliac

6. Internal iliac

11. Imaging guidelines and post-operative follow-up

11.1. General

The long-term performance of endovascular devices has not yet been established. All patients receiving the Talent occluder should receive enhanced follow-up. 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 position of the occluder) 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 occluder until stability of the Talent occluder and the aneurysm has been established.

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 3. This schedule outlines the minimum requirement for patient follow-up and should be maintained even in the absence of clinical symptoms (e.g., pain, numbness, weakness). Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms, or changes in the position of the occluder) 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 (endoleaks), aneurysm growth or changes in the position of the occluder. 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/iliac radiographs provide information on device integrity (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 3. Recommended imaging schedule for Talent occluder patients

Interval

Pre-procedure

Angiogram CT [Contrast & Non-Contrast]

Procedural X

1 Month

3 Month

6 Month

12 Months (annually thereafter)

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 Section 12.0.

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

Xb, c,

b,d,

X X

b,d

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. Note: When the Talent occluder is used in patients with other endovascular stent grafts, also refer to the instructions for use of the endovascular stent graft for additional imaging

recommendations.

11.2. 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 4 below lists examples of accepted imaging protocols.

Table 4. Accepted imaging protocols

Non-contrast

Contrast

IV contrast No Yes

Acceptable machines Spiral capable of > 40 seconds Spiral capable of > 40 seconds

Injection volume N/A 150 cc

Injection rate N/A > 2.5cc/sec

Injection mode N/A Power

Bolus timing N/A Test bolus: SmartPrep, C.A.R.E. or equivalent

Coverage - start Diaphragm 1 cm superior to celiac axis

Coverage - finish Proximal femur Profunda femoris origin

Collimation < 3 mm < 3 mm

Reconstruction 2.5 mm throughout - soft algorithm 2.5 mm throughout - soft algorithm

Axial DFOV 32 cm 32 cm

Post-injection runs None None

11.3. Abdominal/iliac radiographs

The following views are suggested:

■

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). If there is any concern about the device integrity (e.g. stent breaks, migration), it is recommended to use magnified views. The attending physician should evaluate films for device

integrity (entire device length) using 2-4X magnification visual aid.

Abdominal

radiographs

X X

10 Instructions for Use English

11.4. 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, and stenosis. Included on the videotape should be the following information as outlined below:

■

Transverse and longitudinal imaging should be obtained 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

11.5. MRI safety and compatibility

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

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 minutes of scanning 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 minutes of MR scanning in a 64 MHz 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 minutes of scanning (or the maximum SAR allowed by the MR System, whatever is less) 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 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.

Patients with Talent occluder implanted safely undergo MRI for Normal Mode and First Level Controlled Operating Mode of the MR System, as defined in IEC Standard 60601-2-33.

12. Additional surveillance and treatment

Additional surveillance and possible treatment is recommended for:

■

Inadequate seal

■

Endoleaks around the occluder

■

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

■

Migration

■

Stent fracture 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 endovascular procedure.

13. Device-related adverse events reporting

Any adverse event (clinical incident) involving the Talent occluder with occluder delivery system should be reported to Medtronic Vascular immediately. To report an incident, call (800) 465-5533 (in the US).

14. Device registration packet

The Talent occluder is packaged with additional specific information which includes:

■

Temporary Device Identification Card: It includes both patient and device 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 (e.g. MRI). This

temporary identification card should only be discarded when the permanent identification card is received

■

Device Tracking Form: This form should be completed by the hospital staff and forwarded to Medtronic for the purposes of tracking all patients who received a Talent occluder (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

device. Patients should refer to this card anytime they visit health practitioners, particularly for any diagnostic procedures (e.g. 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, contact Medtronic Patient Services.

15. Configurations available

Table 5. Occluder with delivery system

system size (Fr) Diameter (mm) Length (mm)

Delivery

17.5

The delivery system working length is 30 cm for the occluder delivery system.

8 10 12 14 16 18 20 22 24

Instructions for Use English 11

MANUFACTURER:

*M709718B001*

MEDTRONIC, INC. 710 Medtronic Parkway NE Minneapolis, MN 55432 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 or more of the following United States patents: 6,102,938; 6,306,141; & 6,344,052.