Device product
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Z-0689-2016
Product summary
- Event
- Event 72965
- Status
- Terminated
- Classification
- Class II
- Quantity
- 753
- Official record key
device-enforcement:Z-0689-2016
Official wording
Reason: Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event
Code information: Catalog Prefix ZIVX5. All Lots
Distribution pattern: Nationwide Worldwide
Derived failure modes
-
Unknown
Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event