FDA Adverse Event
Injury
Summary report: N
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
MDR report key: 1332937
·
Received February 27, 2009
Report
- Report Number
- 2017233-2009-00114
- Event Type
- Injury
- Date Received
- February 27, 2009
- Report Date
- February 27, 2009
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ARTICLE IS ATTACHED. INOUE Y, SUGANO N, JIBIKI M, ET AL. CUFFED ANASTOMOSIS FOR ABOVE-KNEE FEMOROPOPLITEAL BYPASS WITH A STRETCH EXPANDED POLYTETRAFLUOROETHYLENE GRAFT. SURGERY TODAY 2008; 38:679-684.
Description of Event or Problem · 1
IN THE MEDICAL LITERATURE, IT WAS REPORTED THAT BETWEEN 1997 AND 2005, A PATIENT WAS IMPLANTED WITH A 6MM THIN-WALLED FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT IN AN ABOVE-KNEE FEMOROPOPLITEAL BYPASS PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ANASTOMOTIC PSEUDOANEURYSM THAT DEVELOPED IN THE GROIN POSTOPERATIVELY WITHIN 11 MONTHS AFTER IMPLANTATION. THIS WAS TREATED BY ANEURYSMECTOMY AND INTERPOSITION USING A 6MM THIN-WALLED FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT | NONE | DSY | W.L. GORE & ASSOCIATES | WLG402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |