FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1050322
·
Received May 22, 2008
Report
- Report Number
- 2017233-2008-00280
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- April 25, 2008
- Report Date
- May 21, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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.
Description of Event or Problem · 1
THE PT WAS TREATED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT AND A CONTRALATERAL LEG COMPONENT IN 2007. IN 2008, CT IMAGES REVEALED AN INFECTED GRAFT AND A TYPE II ENDOLEAK. THE PHYSICIAN DECIDED TO PERFORM AN AXILLARY-BIFEMORAL BYPASS, FOLLOWED BY THE EXPLANTING OF THE GORE EXCLUDER AAA ENDOPROSTHESIS. THE PT IS ALIVE, PENDING TRANSFER TO REHABILITATION.
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 | 04673247 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |