FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2233967
·
Received August 30, 2011
Report
- Report Number
- 2953161-2011-00185
- Event Type
- Injury
- Date Received
- August 30, 2011
- Date of Event
- June 15, 2011
- Report Date
- August 29, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK IS BEING CONDUCTED. (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2009, THE PT WAS IMPLANTED WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2011, A COMPUTED TOMOGRAPHY REVEALED A PROX TYPE I ENDOLEAK ORIGINATING FROM THE AORTIC EXTENDER COMPONENT. ON (B)(6) 2011, A REINTERVENTION WAS ATTEMPTED TO TREAT THE PROX TYPE I ENDOLEAK. THE PHYSICIAN BALLOONED THE DEVICE AND IT WAS REALIZED THAT THERE WAS NOT A TYPE I ENDOLEAK BUT INSTEAD A TYPE II ENDOLEAK, THE ENDOLEAK WAS NOT TREATED DURING THE PROCEDURE AND THE PHYSICIAN HAS CHOSEN TO TAKE A WAIT AND WATCH APPROACH. THE PT TOLERATED THE PROCEDURE.
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 | 7024125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R | CLOPIDOGREL| EZETIMIBE |