Device product
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Z-0083-2014
Product summary
- Event
- Event 66322
- Status
- Terminated
- Classification
- Class II
- Quantity
- ~1000
- Official record key
device-enforcement:Z-0083-2014
Official wording
Reason: Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
Code information: TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.
Distribution pattern: International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Derived failure modes
-
Unknown
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.