FDA Adverse Event
Death
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1030860
·
Received April 16, 2008
Report
- Report Number
- 2953161-2008-00075
- Event Type
- Death
- Date Received
- April 16, 2008
- Date of Event
- February 19, 2008
- Report Date
- April 16, 2008
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK IS BEING CONDUCTED. PLEASE NOTE ADDITIONAL DEVICE IMPLANTED IN THIS PT. PXC141400/05643402.
Description of Event or Problem · 1
IN 2008, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR USING GORE EXCLUDER AAA ENDOPROSTHESES. DURING FINAL BALLOON DILATION, THE PT SUFFERED A STROKE AND WAS ADMINISTERED ANTICOAGULATION THERAPY. THAT NIGHT, THE PT EXPIRED DUE TO BLEEDING FROM THE LEFT FEMORAL SITE OF ACCESS, WHICH WAS A PERCUTANEOUS CLOSURE SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W. L. GORE & ASSOCIATES, INC. | WLG325 | 05577165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death |