FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2122944
·
Received June 10, 2011
Report
- Report Number
- 2953161-2011-00135
- Event Type
- Injury
- Date Received
- June 10, 2011
- Date of Event
- May 11, 2011
- Report Date
- June 9, 2011
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2010, THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2011, THE PATIENT REPORTED AN ALLERGIC REACTION TO THE STENT-GRAFTS. NO TEST RESULTS ARE AVAILABLE TO DIAGNOSE A POSSIBLE ALLERGIC REACTION, HOWEVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. | WLG425 | 8356519 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Other | CARDIAC STENTS| PACEMAKER| NIMODIPINE| METFORMIN| SIMVASTATIN| METOPROLOL| CIPRO |