FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1024346
·
Received February 7, 2008
Report
- Report Number
- 2017233-2008-00061
- Event Type
- Injury
- Date Received
- February 7, 2008
- Date of Event
- October 4, 2007
- Report Date
- February 7, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES, INC
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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
ON MARCH 23, 2006, A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK IPSILATERAL LEG COMPONENT WAS IMPLANTED. IN 2007, A GORE EXCLUDER AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WAS IMPLANTED. FURTHER INVESTIGATION IS PENDING.
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 | 03797251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |