FDA Adverse Event
Injury
Summary report: N
GORE PROPATEN VASCULAR GRAFT
MDR report key: 1241530
·
Received November 21, 2008
Report
- Report Number
- 2017233-2008-00902
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- May 12, 2008
- Report Date
- November 21, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET COMPLETED. THE INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 1
IN 2008, A GORE PROPATEN VASCULAR GRAFT WAS IMPLANTED AS A LEFT COMMON FEMORAL TO POPLITEAL BYPASS. TWO MONTHS LATER, A PORTION AT THE PROXIMAL END WAS EXPLANTED DUE TO BLEEDING AND INFECTION AT THE ANASTOMOSIS. THERE WAS NO DEHISCENCE OF THE ORIGINAL GRAFT OR SUTURE. A LEFT EXTERNAL ILIAC-FEMORAL POPLITEAL BYPASS USING A GORE PROPATEN VASCULAR GRAFT WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE PROPATEN VASCULAR GRAFT | NONE | DSY | W.L. GORE & ASSOCIATES | WLG450 | 2143134PP026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |