FDA Adverse Event
Injury
Summary report: N
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
MDR report key: 1332938
·
Received February 27, 2009
Report
- Report Number
- 2017233-2009-00119
- 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
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: 679-384.
Description of Event or Problem · 1
IN A MEDICAL LITERATURE, IT WAS REPORTED THAT BETWEEN EARLY 1997 AND LATE 2005, A PATIENT WAS IMPLANTED WITH A 6MM THIN-WALLED FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT AS AN ABOVE-KNEE FEMOROPOPLITEAL BYPASS PROCEDURE. IT WAS REPORTED THAT A GRAFT INFECTION OCCURRED WITHIN 11 MONTHS AFTER IMPLANTATION. THE PATIENT UNDERWENT COMPLETE GRAFT REMOVAL WITHOUT VASCULAR RECONSTRUCTION.
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 |