Device product
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.
Z-1121-2025
Product summary
- Event
- Event 96114
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11 units
- Official record key
device-enforcement:Z-1121-2025
Official wording
Reason: Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Code information: Lot number: 0000456768
Distribution pattern: US: None OUS: China
Derived failure modes
-
Unknown
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.