FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1000175
·
Received February 18, 2008
Report
- Report Number
- 2953161-2008-00034
- Event Type
- Injury
- Date Received
- February 18, 2008
- Date of Event
- January 22, 2008
- Report Date
- February 15, 2008
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. TYPE II ENDOLEAK.
Description of Event or Problem · 1
IN 2003, A GORE EXCLUDER BIFURCATED ENDOPROSTHESIS WAS IMPLANTED TO REPAIR AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. POSTOPERATIVE IMAGES REVEALED A TYPE II ENDOLEAK AND ANEURYSMAL SAC ENLARGEMENT. IN 2008, COIL EMBOLIZATION WAS PERFORMED. IT WAS REPORTED THAT THE TYPE II ENDOLEAK HAD DIMINISHED AND THAT THE PATIENT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | ENDOVASCULAR GRAFT SYSTEM | MIH | W. L. GORE & ASSOCIATES, INC. | WLG325 | 030232806 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |