FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2112267
·
Received May 24, 2011
Report
- Report Number
- 2017233-2011-00248
- Event Type
- Injury
- Date Received
- May 24, 2011
- Date of Event
- September 15, 2009
- Report Date
- May 23, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2007, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. IN (B)(6) 2009, THE PT PRESENTED WITH BACK AND ABDOMINAL PAIN. THERE WAS AN ENDOLEAK DUE TO A LACK OF SEAL AT THE DISTAL END OF THE DEVICE. THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND SEVERAL WEEKS LATER ON (B)(6) 2009, ANOTHER CONTRALATERAL LEG WAS IMPLANTED, RESOLVING THE ENDOLEAK.
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 | WLG325 | 04869627 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R | METOPROLOL| GLYBURIDE| LASIX| LOVASTATIN| AORTIC VALVE REPLACEMENT| ASPIRIN| CABG |