FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1132130
·
Received August 21, 2008
Report
- Report Number
- 2017233-2008-00498
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- July 6, 2007
- Report Date
- August 20, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PLEASE NOTE ADDITIONAL DEVICE USED IN THIS PROCEDURE: GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK IPSILATERAL LEG COMPONENT (PXT261414/04924407).
Description of Event or Problem · 1
IN 2008, THIS PATIENT WAS TREATED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT AND A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK IPSILATERAL LEG COMPONENT. TWO MONTHS LATER, PATIENT PRESENTED WITH A PERSISTENT ENDOLEAK AND ANEURYSM ENLARGEMENT. THE PATIENT WAS CONVERTED TO AN OPEN REPAIR AND 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 | WLG325 | 04488714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |