FDA Adverse Event
Injury
Summary report: N
THIN-WALLED FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT WITH REMOVABLE RINGS (LIN
MDR report key: 1091845
·
Received July 31, 2008
Report
- Report Number
- 2017233-2008-00423
- Event Type
- Injury
- Date Received
- July 31, 2008
- Date of Event
- June 23, 2008
- Report Date
- July 31, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET COMPLETED.
Description of Event or Problem · 1
IN 2008, A FEM-POP BYPASS WITH A THIN-WALLED FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT WITH REMOVABLE RINGS (LINED) WAS PERFORMED. THE BYPASS THROMBOSED WITHIN 2 DAYS OF IMPLANT. ON TWO DAYS LATER, A BYPASS THROMBECTOMY WAS PERFORMED AT THE DISTAL ANASTOMOSIS. BLEEDING WAS NOTED AT THE THROMBECTOMY SITE WHERE THE THIN-WALLED FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT RINGS HAD BEEN REMOVED FOR INTRODUCTION OF THE THROMBECTOMY CATHETER. THE GRAFT WAS REPLACED WITH A NEW THIN-WALLED FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT. THE PT IS OK. FURTHER INVESTIGATION IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THIN-WALLED FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT WITH REMOVABLE RINGS (LIN | NONE | DSY | W.L. GORE & ASSOCIATES | WLG402 | 05590427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |