FDA Adverse Event
Injury
Summary report: N
GORE VIABAHN ENDOPROSTHESIS
MDR report key: 2211294
·
Received August 3, 2011
Report
- Report Number
- 2017233-2011-00395
- Event Type
- Injury
- Date Received
- August 3, 2011
- Date of Event
- July 13, 2011
- Report Date
- August 2, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- NIP
- PMA / PMN Number
- P040037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2011, A MALE PT WAS IMPLANTED WITH TWO GORE VIABAHN ENDOPROSTHESIS FOR AN ANEURYSM IN THE POPLITEAL ARTERY. IT WAS REPORTED TO GORE THAT ON (B)(6) 2011, THE GORE VIABAHN ENDOPROSTHESIS THROMBOSED. THE PHYSICIAN EXPLANTED THE DEVICES AND PERFORMED A BYPASS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE VIABAHN ENDOPROSTHESIS | NIP / STENT, SUPERFICIAL FEMORAL ARTERY | NIP | W.L. GORE & ASSOCIATES | WLG335 | 8776980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Required Intervention | GORE VIABAHN ENDOPROTHESIS - LOT #8596042 |