FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 3170396
·
Received June 7, 2013
Report
- Report Number
- 2017233-2013-00365
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- May 30, 2013
- Report Date
- May 10, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2011, THIS PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON (B)(6) 2013, THAT A FOLLOW-UP NON-CONTRAST COMPUTED TOMOGRAPHY IMAGING IDENTIFIED ANEURYSM ENLARGEMENT 5.6 TO 6.1 CM. ON AN UNK DATE, AN ANGIOGRAM IDENTIFIED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2013, A REINTERVENTION WAS PERFORMED WHEREBY AN AORTIC EXTENDER COMPONENT WAS IMPLANTED FOR PROXIMAL EXTENSION TO TREAT THE TYPE I ENDOLEAK. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAK, AND THE PT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253625 | GORE EXCLUDER AAA ENDOPROSTHESIS | MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 7824353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | PLAVIX| LISINOPRIL| METOPROLOL| CADUET| METFORMIN |