FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2251004
·
Received September 12, 2011
Report
- Report Number
- 2017233-2011-00466
- Event Type
- Injury
- Date Received
- September 12, 2011
- Date of Event
- August 31, 2011
- Report Date
- September 12, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS BEING RETURNED TO GORE FOR EVALUATION. ADDITIONAL INFO WILL BE INCLUDED IN THE FINAL REPORT. LOT/SERIAL NUMBERS WERE REQUESTED, HOWEVER ACCORDING TO THE PHYSICIAN, THAT INFO IS NOT AVAILABLE.
Description of Event or Problem · 1
ON AN UNK DATE IN 2004, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER BIFURCATED ENDOPROSTHESES. IN (B)(6) 2011, FOLLOW UP EVALUATION REVEALED THAT THE ANEURYSM SAC HAD INCREASED IN SIZE, WITH NO SIGN OF ENDOLEAK. ON (B)(6) 2011, THE DEVICES WERE EXPLANTED AND THE PT WAS CONVERTED TO AN OPEN REPAIR.
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 | 67 YR | Hospitalization| R |