FDA Adverse Event
Injury
Summary report: N
GORE VIABAHN ENDOPROSTHESIS
MDR report key: 1032835
·
Received April 22, 2008
Report
- Report Number
- 2017233-2008-00141
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- March 24, 2008
- Report Date
- April 18, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES, INC.
- Product Code
- NIP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
A GORE VIABAHN ENDOPROSTHESIS WAS USED DURING THE TREATMENT OF A SFA OCCLUSION. DURING DEPLOYMENT OF THE DEVICE, THE DEPLOYMENT STRING BROKE CAUSING ONLY HALF OF THE DEVICE TO FULLY DEPLOY. ATTEMPTS TO RETRIEVE THE END OF THE DEPLOYMENT LINE TO COMPLETE DEPLOYMENT WERE UNSUCCESSFUL. THE PHYSICIAN PERFORMED OPEN SURGERY TO REMOVE THE DEVICE AND PERFORM A FEM-POP BYPASS PROCEDURE. THE PATIENT WAS FINE POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE VIABAHN ENDOPROSTHESIS | PERIPHERAL ENDOVASCULAR STENT GRAFT | NIP | W.L. GORE & ASSOCIATES, INC. | WLG335 | 05613207 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |