FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1923593
·
Received December 9, 2010
Report
- Report Number
- 2017233-2010-00546
- Event Type
- Injury
- Date Received
- December 9, 2010
- Date of Event
- December 7, 2010
- Report Date
- December 9, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2010, THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESIS. ON (B)(6) 2010, THE PATIENT UNDERWENT ANOTHER PROCEDURE TO ADDRESS A PROXIMAL TYPE I ENDOLEAK. AN AORTIC EXTENDER WAS PLACED, RESOLVING THE ENDOLEAK. NO OTHER COMPLICATIONS WERE REPORTED. THE ENDOLEAK WAS ATTRIBUTED TO A CALCIFIED INFRARENAL AORTA.
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 | WLG425 | 06779008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Hospitalization| R |