Device product
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
Z-1591-2021
Product summary
- Event
- Event 87721
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 550 units
- Official record key
device-enforcement:Z-1591-2021
Official wording
Reason: The firm has received reports of stent migration after implantation
Code information: all batches/lots of the device manufactured between May 2018 through April 2021
Distribution pattern: Worldwide - US Nationwide Distribution
Derived failure modes
-
Unknown
The firm has received reports of stent migration after implantation