Inhaltsverzeichnis; Device Description - Medtronic Valiant Navion Gebrauchsanweisung

Valiant Navion™
Thoracic Stent Graft System-Instructions for Use
Table of contents
1. Device description ........................................................................................................................................................... 5
2. Indications for use ........................................................................................................................................................... 7
3. Contraindications ............................................................................................................................................................ 7
4. Warnings and precautions .............................................................................................................................................. 8
5. Adverse events .............................................................................................................................................................. 10
6. Patient selection, treatment, and device selection .................................................................................................... 11
7. Patient counseling information .................................................................................................................................... 15
8. How supplied ................................................................................................................................................................. 16
9. Directions for use .......................................................................................................................................................... 16
10. Troubleshooting techniques ........................................................................................................................................ 24
11. Follow-up imaging recommendations ......................................................................................................................... 28
12. Additional surveillance and treatment ......................................................................................................................... 29
13. Disclaimer of warranty .................................................................................................................................................. 30

1. Device description

Important!
■
Do not attempt to use the Valiant Navion thoracic stent graft system before completely reading and understanding
the information contained in this instructions for use.
■
Carefully inspect all product packaging for damage or defects before use. Do not use 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 system in accordance with
hospital, administrative, and/or government policies. Do not resterilize.
The Valiant Navion™ thoracic stent graft system is designed for the endovascular repair of lesions in the descending thoracic
aorta (DTA). When placed within the target lesion, the stent graft provides an alternative conduit for blood flow within the
patient's vasculature by excluding the lesion from blood flow and pressure.
The stent graft system is composed of 2 main components: the implantable Valiant Navion thoracic stent graft and the
disposable delivery system. The stent graft is preloaded into the delivery system. The loaded delivery system is inserted
endoluminally via the femoral or iliac artery and tracked through the patient's vasculature to deliver the stent graft to the target
site. Upon deployment, the stent graft self-expands to conform to the shape and size of the seal zones above and below the
lesion.
The Valiant Navion thoracic stent graft system does not contain natural rubber latex; however, during the manufacturing
process, it may have had incidental contact with latex-containing products.
1.1. Stent graft
A single, primary Valiant Navion thoracic stent graft may be used by itself if its size is sufficient to provide the desired coverage.
Alternatively, it may be used in combination with additional Valiant Navion thoracic stent graft configurations that increase the
graft length distally or proximally to the primary section.
All stent grafts are composed of a self-expanding stent scaffold made from nitinol wire sewn to a fabric graft with nonresorbable
sutures. The metal scaffolding is composed of a series of serpentine stents stacked in a tubular configuration. Radiopaque
(RO) markers are sewn onto each component of the stent graft to aid in visualization and to facilitate accurate placement. The
nitinol stents are also visible under fluoroscopy. Refer to Table 1 (Stent graft materials) for a summary of the stent graft
materials.
The appropriate device sizing is incorporated into the sizing guidelines. Refer to Section 6.3 (Recommended device sizing)
and Section 6.4 (Device sizing recommendations) for detailed sizing information for all stent graft components.
Component Material
Stents Nitinol (nickel-titanium) alloy
RO markers Platinum-iridium alloy
Graft fabric Polyester (PET)
Suture Polyester (PET) and ultra-high-molecular-weight polyethylene (UHMWPE)
Table 1. Stent graft materials
Instructions for Use English 5