Device product
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Z-0290-2022
Product summary
- Event
- Event 88951
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 devices
- Official record key
device-enforcement:Z-0290-2022
Official wording
Reason: During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Code information: Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639
Distribution pattern: Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
Derived failure modes
-
Unknown
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube