FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1060882
·
Received June 13, 2008
Report
- Report Number
- 2953161-2008-00151
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- March 28, 2008
- Report Date
- June 13, 2008
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSION: INFECTION.
Description of Event or Problem · 1
AS REPORTED, IN 2007, THE PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES FOR THE TREATMENT OF AN INFRARENAL ABDOMINAL ANEURYSM 10 CM IN DIAMETER. IN 2008, THE PT PRESENTED WITH AN INFRARENAL ABDOMINAL AORTIC ANEURYSM WITH AN INTRA-AORTIC ANEURISMAL ABSCESS WITH SECONDARY AORTODUODENAL FISTULIZATION. THE PT UNDERWENT A RIGHT AXILLOBIFEMORAL BYPASS GRAFT, EXPLORATORY LAPAROTOMY AND EXCISION OF THE INFECTED INFRARENAL AORTIC ENDOGRAFT. DUODENAL ENTERORRHAPHY AND WITH OMENTAL PATCH PLACEMENT WAS PERFORMED TO REPAIR THE AORTODUODENAL FISTULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W. L. GORE & ASSOCIATES, INC. | WLG325 | 05018768 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |