FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1132094
·
Received August 21, 2008
Report
- Report Number
- 2953161-2008-00215
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- July 31, 2008
- Report Date
- August 20, 2008
- Manufacturer
- W. L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.
Description of Event or Problem · 1
IN 2007, TWO GORE EXCLUDER AAA ENDOPROSTHESES CONTRALATERAL LEG COMPONENTS WERE IMPLANTED. AN ANEURX DEVICE WAS ALSO USED. IN 2008 A REINTERVENTION OCCURRED WHERE AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED INTO THE PT, DUE TO A DISTAL TYPE I ENDOLEAK. THE PT'S RIGHT HYPOGASTRIC ARTERY WAS COILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | ENDOVASCULAR GRAFT SYSTEM | MIH | W. L. GORE & ASSOCIATES | WLG325 | 05105895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |