FDA Adverse Event
Injury
Summary report: N
GORE VIABAHN ENDOPROSTHESIS
MDR report key: 2869904
·
Received December 4, 2012
Report
- Report Number
- 2017233-2012-00806
- Event Type
- Injury
- Date Received
- December 4, 2012
- Date of Event
- October 20, 2008
- Report Date
- November 5, 2012
- Manufacturer
- W.L. GORE & ASSOCIATES,INC
- 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
NOTE: GORE ATTEMPTED TO ACQUIRE INFO REQUIRED FOR THIS FORM. THIS EVENT INCLUDED 4 GORE VIABAHN ENDOPROSTHESIS. REFER TO THE FOLLOWING: DEVICE 1 - MEDWATCH NUMBER: 2017233-2012-00802, DEVICE 2 - MEDWATCH NUMBER: 2017233-2012-00804, DEVICE 3 - MEDWATCH NUMBER: 2017233-2012-00805, DEVICE 4 - MEDWATCH NUMBER: 2017233-2012-00806.
Description of Event or Problem · 1
THE GORE VIABAHN ENDOPROSTHESIS WAS IMPLANTED (B)(6) 2008. IT WAS REPORTED TO GORE THAT THE GORE 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 FEMORAL ARTERY | NIP | W.L. GORE & ASSOCIATES,INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |