FDA Adverse Event
Injury
Summary report: N
GORE VIABAHN ENDOPROSTHESIS
MDR report key: 2071869
·
Received April 25, 2011
Report
- Report Number
- 2017233-2011-00213
- Event Type
- Injury
- Date Received
- April 25, 2011
- Date of Event
- May 3, 2007
- Report Date
- April 25, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- NIP
- PMA / PMN Number
- P040037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FOLLOWING INTERVENTION WITH THE ROTAREX DEVICE TO PERFORM A THROMBECTOMY, THE DEVICE IS FUNCTIONING AND REMAINS IMPLANTED.
Description of Event or Problem · 1
A 6X10 VIABAHN DEVICE WAS IMPLANTED IN THE SFA FOR TREATMENT OF A SFA ANEURYSM IN THE LEFT LEG. SINCE THE SFA AND POPLITEAL ARTERIES WERE ALSO STENOTIC, THE POPLITEAL ARTERY WAS STENTED WITH A DIFFERENT MFR'S DEVICE. TWO WEEKS LATER, THE VIABAHN DEVICE OCCLUDED. FLOW WAS RESTORED USING A ROTAREX (THROMBECTOMY) DEVICE.
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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |