FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1249803
·
Received December 2, 2008
Report
- Report Number
- 2017233-2008-00920
- Event Type
- Injury
- Date Received
- December 2, 2008
- Date of Event
- June 19, 2008
- Report Date
- December 1, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES,INC
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECS. PLEASE NOTE THAT AN ADD'L DEVICE IMPLANTED IN THE ORIGINAL PROCEDURE.
Description of Event or Problem · 1
IN 2004, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. A CONTROL CT (UNK DATE) SHOWED A GROWING ANEURYSM WITHOUT DETECTABLE ENDOLEAK. IN 2008, AN OPEN SURGICAL REPAIR WAS PERFORMED. A TYPE II ENDOLEAK WAS DISCOVERED. THE TWO GORE EXCLUDER AAA ENDOPROSTHESES WERE EXPLANTED. A GORE SBT PROSTHESIS WAS IMPLANTED. THE PT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES,INC | WLG325 | 02872308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |