Device product
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361
Z-0291-2024
Product summary
- Event
- Event 93195
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 141 units
- Official record key
device-enforcement:Z-0291-2024
Official wording
Reason: Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Code information: UDI-DI: 00650862853612 Lot Numbers: 464909, 464910
Distribution pattern: Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
Derived failure modes
-
Unknown
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.