FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1241529
·
Received November 21, 2008
Report
- Report Number
- 2017233-2008-00894
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- October 23, 2008
- Report Date
- November 21, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK HAD BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.
Description of Event or Problem · 1
IN '08, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT A SACCULAR MYCOTIC ABDOMINAL AORTIC ANEURYSM. AT APPROXIMATELY 20 DAYS LATER, THE PT PRESENTED AT THE HOSP WITH PAIN IN HER LEG (SIDE UNK). CTA REVEALED OCCLUSION OF THE RIGHT INTERIOR AND RIGHT EXTERIOR ILIAC ARTERIES. IN THE NEXT DAY, A REINTERVENTION OCCURRED WHERE A FEMORAL-FEMORAL BYPASS WAS PERFORMED. THE PT TOLERATED THE PROCEDURE AND IS REPORTED TO BE STABLE WITH NO FURTHER COMPLICATIONS AT THIS TIME. FILMS WERE SENT TO GORE AND ARE BEING EVALUATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES | WLG325 | 05454768 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |