FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1033826
·
Received April 24, 2008
Report
- Report Number
- 2017233-2008-00157
- Event Type
- Injury
- Date Received
- April 24, 2008
- Date of Event
- March 5, 2008
- Report Date
- April 23, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES,INC
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IN 2006, A COOK MAIN BODY ENDOVASCULAR STENT AND A GORE EXCLUDER AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WERE IMPLANTED TO REPAIR AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL END OF THE GRAFT MIGRATED AND A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED. IN 2008, THE PATIENT WAS CONVERTED TO OPEN SURGICAL REPAIR. ACCORDING TO THE IMPLANTING PHYSICIAN, THE EVENT WAS NOT ASSOCIATED WITH THE GORE EXCLUDER AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT. FURTHER INVESTIGATION IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES,INC | WLG325 | 04494100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |