FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1050319
·
Received May 22, 2008
Report
- Report Number
- 2017233-2008-00279
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- November 29, 2006
- Report Date
- May 21, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PROXIMAL TYPE I ENDOLEAK.
Description of Event or Problem · 1
IN 2006, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. ABOUT 2 DAYS LATER, THE PT UNDERWENT OPEN REPAIR DUE TO A PROXIMAL TYPE I ENDOLEAK. THE DEVICES REMAIN IN THE PT. THE PT IS REPORTED TO BE IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES, INC. | WLG325 | 04517425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |