FDA Adverse Event
Malfunction
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1081871
·
Received July 21, 2008
Report
- Report Number
- 2017233-2008-00386
- Event Type
- Malfunction
- Date Received
- July 21, 2008
- Date of Event
- May 19, 2008
- Report Date
- July 18, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.
Description of Event or Problem · 1
AS REPORTED, IN 2008, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. POST-OPERATIVE IMAGES REVEALED DEVICE INFOLDING IN THE RIGHT COMMON ILIAC ARTERY. THE PATIENT REMAINS ASYMPTOMATIC WITH NO BLOOD FLOW CHALLENGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES | WLG325 | 05174102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |