FDA Adverse Event
Death
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1734121
·
Received June 21, 2010
Report
- Report Number
- 2017233-2010-00297
- Event Type
- Death
- Date Received
- June 21, 2010
- Date of Event
- March 24, 2010
- Report Date
- June 18, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL DEVICES IMPLANTED: (B) (4), (B) (4), (B) (4), (B) (4).
Description of Event or Problem · 1
ON (B) (6) 2010, THE PATIENT WAS IMPLANTED WITH FIVE GORE EXCLUDER AAA ENDOPROSTHESES TO REPAIR AND ABDOMINAL AORTIC ANEURYSM. ON (B) (6) 2010, THE PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | WLG325 | 06044546 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Death |