FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2211279
·
Received August 3, 2011
Report
- Report Number
- 2017233-2011-00397
- Event Type
- Injury
- Date Received
- August 3, 2011
- Date of Event
- July 8, 2011
- Report Date
- August 3, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO GORE FOR ANALYSIS. ADD'L INFO REGARDING THIS EVENT HAS BEEN REQUESTED.
Description of Event or Problem · 1
IN 2001, THE PT WAS IMPLANTED WITH THE GORE EXCLUDER BIFURCATED ENDOPROSTHESIS TO TREAT AN AORTIC ANEURYSM. ON (B)(6) 2011, THE DEVICE WAS EXPLANTED DUE TO ANEURYSM SAC GROWTH DUE TO ENDOTENSION.
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 | WLG425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |