FDA Adverse Event
Injury
Summary report: N
GORE PROPATEN VASCULAR GRAFT
MDR report key: 1911780
·
Received November 24, 2010
Report
- Report Number
- 2017233-2010-00527
- Event Type
- Injury
- Date Received
- November 24, 2010
- Date of Event
- May 15, 2007
- Report Date
- November 23, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- 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
ON (B)(6) 2007, A 6MM GORE PROPATEN VASCULAR GRAFT WAS IMPLANTED IN A BYPASS PROCEDURE. THE IMPLANT WAS IN THE PT'S LEFT LEG, FROM THE EXTERNAL ILIAC TO ANTERIOR TIBIAL ARTERY. TWO EPISODES OF THROMBOSIS WERE NOTED. ON (B)(6) 2007, A THROMBECTOMY WAS PERFORMED AT PROXIMAL ANASTAMOSIS AND THE GRAFT WAS REMOVED. ON (B)(4) 2007, AN AMPUTATION WAS DONE.
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 | WLG450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |