FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1201465
·
Received October 17, 2008
Report
- Report Number
- 2953161-2008-00311
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- March 30, 2007
- Report Date
- October 16, 2008
- Manufacturer
- W. L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD - A REVIEW OF THE MFG RECORDS HAS BEEN CONDUCTED. RESULTS - THE MFG RECORDS REVIEW VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
IN 2007, THE PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. AT ABOUT TWO MONTHS LATER, THE PT UNDERWENT AN ADDITIONAL PROCEDURE TO IMPLANT AN AORTIC EXTENDER. FURTHER INVESTIGATION IS BEING CONDUCTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W. L. GORE & ASSOCIATES | WLG325 | 04779224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other| R |