FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1243774
·
Received November 24, 2008
Report
- Report Number
- 2953161-2008-00399
- Event Type
- Injury
- Date Received
- November 24, 2008
- Date of Event
- November 11, 2008
- Report Date
- November 24, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. THE MANUFACTURING RECORDS REVIEW VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
IN 2008, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. THE PROCEDURE WENT AS PLANNED, EXCEPT THE RIGHT INTERNAL ILIAC ARTERY WAS UNINTENTIONALLY COVERED BY THE CONTRALATERAL LEG COMPONENT. THE PATIENT IS STABLE WITH NO COMPLICATIONS. NO ADDITIONAL INTERVENTION IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES | WLG325 | 05794882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |