Device product
ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD) ranging from 4.0-6.0 mm and total lesion lengths up to 190 mm.
Z-1621-2021
Product summary
- Event
- Event 87839
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 UNITS
- Official record key
device-enforcement:Z-1621-2021
Official wording
Reason: One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
Code information: LOT: 25838357
Distribution pattern: US Nationwide distribution in the states of AL, AR, AZ, CA, DE, HI, IL, KS, KY, MA, MD, NC, NJ, NV, NY, OH, OK, PA,PR, TX, VA,WA,WV.
Derived failure modes
-
Unknown
One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.