Device product
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Z-0464-2022
Product summary
- Event
- Event 89140
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21,653 devices
- Official record key
device-enforcement:Z-0464-2022
Official wording
Reason: There have been reports of stent migration.
Code information: The IFU for all model numbers and serial numbers.
Distribution pattern: Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Bahrain, Belgium, Botswana, Bulgaria, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kenya, Lithuania, Malaysia, Republic of Moldova, Netherlands, New Zealand, Nicaragua, Norway, Oman, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, and Viet Nam,
Derived failure modes
-
Unknown
There have been reports of stent migration.