FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1180049
·
Received September 26, 2008
Report
- Report Number
- 2953161-2008-00276
- Event Type
- Injury
- Date Received
- September 26, 2008
- Date of Event
- August 18, 2008
- Report Date
- September 23, 2008
- Manufacturer
- W. L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: USER INTERFACE CONTRIBUTED TO EVENT. THE DEVICE WAS APPLIED OUTSIDE OF THE INDICATIONS FOR USE. THE ILIAC DIAMETER WAS SMALLER THAN RECOMMENDED FOR THE DEVICE SIZE.
Description of Event or Problem · 1
IN 2008, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESIS TO TREAT AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. TEN DAYS LATER, A BARE METAL STENT WAS IMPLANTED TO RESOLVE DISTAL INFOLDING. THE PATIENT IS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W. L. GORE & ASSOCIATES | WLG325 | 05897713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |