FDA Adverse Event
Injury
Summary report: N
GORE PROPATEN VASCULAR GRAFT
MDR report key: 2002378
·
Received February 16, 2011
Report
- Report Number
- 2017233-2011-00070
- Event Type
- Injury
- Date Received
- February 16, 2011
- Date of Event
- April 17, 2007
- Report Date
- February 15, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES, INC.
- Product Code
- DSY
- PMA / PMN Number
- K062161
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT WAS FOUND TO HAVE AN AV FISTULA IN THE POPLITEAL FOSSA AT THE DISTAL ANASTOMOSIS OF THE ORIGINAL GORE PROPATEN VASCULAR GRAFT. ON (B)(6) 2007, A REINTERVENTION WAS DONE USING A NEW GORE PROPATEN VASCULAR GRAFT. THE IMPLANT WAS FROM A PRE-EXISTING GRAFT AT THE DISTAL POPLITEAL TO POSTERIOR TIBIAL ARTERY. A HEMATOMA WAS SURGICALLY EVACUATED ON (B)(6) 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE PROPATEN VASCULAR GRAFT | DSY/PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | DSY | W.L. GORE & ASSOCIATES, INC. | WLG450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |