FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1050326
·
Received May 22, 2008
Report
- Report Number
- 2017233-2008-00284
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- March 5, 2007
- Report Date
- May 21, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PLEASE NOTE: ATTACHED LIST OF ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXT261218/LOT#04761787.
Description of Event or Problem · 1
IN 2007, A GORE EXCLUDER AAA ENDOPROSTHESIS WAS IMPLANTED TO REPAIR AN ILIAC ANEURYSM. ON THE FOLLOWING MONTH, THE PT HAD RIGHT LEG PAIN. IT WAS REPORTED THAT A DEVICE LIMB HAD OCCLUDED AND THE PT DID NOT HAVE BLOOD FLOW AT THE LEVEL OF THE FEMORAL ARTERY. THE NEXT DAY, A FEMOROFEMORAL BYPASS GRAFT WAS IMPLANTED. THE PT'S BLOOD FLOW AND RIGHT LEG PAIN HAS IMPROVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES | WLG325 | 04627136 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |