FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1201542
·
Received October 17, 2008
Report
- Report Number
- 2953161-2008-00312
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- September 19, 2008
- Report Date
- October 16, 2008
- Manufacturer
- W. L. GORE & ASSOCIATES,
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG RECORDS IS BEING CONDUCTED. ADDITIONAL DEVICES: PCC141200/030242108.
Description of Event or Problem · 1
IN 2004, THE PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNK DATE, THE PT PRESENT WITH ANEURYSM SAC ENLARGEMENT, WITH NO EVIDENCE OF ENDOLEAKS. IN 2008, THE DEVICES WERE RELINED BECAUSE OF SUSPECTED ENDOTENSION. THE PROCEDURE WENT AS PLANNED, AND THE PT IS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W. L. GORE & ASSOCIATES, | WLG325 | 030242108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other| R |