FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1140247
·
Received August 29, 2008
Report
- Report Number
- 2953161-2008-00232
- Event Type
- Injury
- Date Received
- August 29, 2008
- Date of Event
- August 13, 2008
- Report Date
- August 28, 2008
- Manufacturer
- W. L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED.
Description of Event or Problem · 1
IN 2008, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING A FOLLOW-UP ABOUT 55 DAYS POST PROCEDURE, CT SCAN IMAGES REVEALED AN ANEURYSM RUPTURE AND AN INFECTED GRAFT. A REINTERVENTION OCCURRED ABOUT 7 DAYS LATER. THE INFECTED GRAFTS WERE EXPLANTED AND DISCARDED AT THE FACILITY. THE PATIENT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W. L. GORE & ASSOCIATES | WLG325 | 05576868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |