FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 967196
·
Received December 18, 2007
Report
- Report Number
- 2017233-2007-00448
- Event Type
- Injury
- Date Received
- December 18, 2007
- Date of Event
- November 16, 2007
- Report Date
- December 17, 2007
- Manufacturer
- W.L. GORE & ASSOCIATES,INC
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A REPAIR WAS PERFORMED FOR AN ABDOMINAL AORTIC ANEURYSM ON AN UNKNOWN DATE. THE GRAFT WAS ACCURATELY PLACED DURING IMPLANTATION. A PROXIMAL TYPE I ENDOLEAK WAS CAPTURED ON THE ONE MONTH CT SCAN. GORE WAS MADE AWARE OF THE TYPE I ENDOLEAK ON 11/16/2007. FURTHER INVESTIGATION IS NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | ENDOVASCULAR GRAFT SYSTEM | MIH | W.L. GORE & ASSOCIATES,INC | WLG325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |