FDA Adverse Event
Injury
Summary report: N
GORE PROPATEN VASCULAR GRAFT
MDR report key: 1346712
·
Received March 16, 2009
Report
- Report Number
- 2017233-2009-00146
- Event Type
- Injury
- Date Received
- March 16, 2009
- Report Date
- March 13, 2009
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INITIAL REPORTER IS NOT THE IMPLANTING PHYSICIAN. THE NAME OF THE IMPLANTING PHYSICIAN HAS BEEN REQUESTED.
Description of Event or Problem · 1
AS REPORTED, IN 2007, GE, A MALE PT WAS IMPLANTED WITH A GORE PROPATEN VASCULAR GRAFT AS A LEFT SUPERFICIAL FEMORAL TO BELOW-KNEE POPLITEAL BYPASS. A THROMBOSIS WITHIN 30 DAYS WAS NOTED. THE PHYSICIAN STATED THAT THIS EVENT WAS NOT DEVICE RELATED. NO FURTHER INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE PROPATEN VASCULAR GRAFT | NONE | DSY | W.L. GORE & ASSOCIATES | WLG450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |