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.
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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
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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
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Figure 1. Talent occluder
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7 8
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10
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