FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2012852
·
Received March 1, 2011
Report
- Report Number
- 2953161-2011-00043
- Event Type
- Injury
- Date Received
- March 1, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 28, 2011
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- 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
A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
GORE RECEIVED NOTIFICATION OF AN EXPLANT PROCEDURE INVOLVING GORE EXCLUDER AAA ENDOPROSTHESIS. THESE DEVICES WERE IMPLANTED ON (B)(6), 2007, EXPLANTED ON (B)(6), 2011, AND RETURNED TO GORE FOR ANALYSIS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EXPLANT PROCEDURE, NONE HAS BEEN RECEIVED.
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, INC. | WLG425 | 04539771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R |