FDA Adverse Event
Injury
Summary report: N
GORE VIABAHN ENDOPROSTHESIS
MDR report key: 2870160
·
Received December 4, 2012
Report
- Report Number
- 2017233-2012-00802
- Event Type
- Injury
- Date Received
- December 4, 2012
- Date of Event
- October 20, 2008
- Report Date
- November 5, 2012
- 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
THIS EVENT INCLUDED 4 GORE VIABAHN DEVICES. REFER TO THE FOLLOWING: DEVICE 1 - #2017233-2012-00802; DEVICE 2 - #2017233-2012-00804; DEVICE 3 - #2017233-2012-00805; DEVICE 4 - #2017233-2012-00806.
Description of Event or Problem · 1
THE GORE VIABAHN ENDOPROSTHESIS WAS IMPLANTED (B)(6) 2008. IT WAS REPORTED TO GORE THAT FORE VIABAHN ENDOPROSTHESIS FAILED AND WAS BYPASSED ON (B)(6) 2008 (20 DAYS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE VIABAHN ENDOPROSTHESIS | NIP/STENT, SUPERFICIAL FEM ARTERY | NIP | W.L. GORE & ASSOCIATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |