FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2012556
·
Received February 28, 2011
Report
- Report Number
- 2017233-2011-00088
- Event Type
- Injury
- Date Received
- February 28, 2011
- Date of Event
- June 28, 2010
- Report Date
- February 25, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES,INC
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED.
Description of Event or Problem · 1
ON (B)(6), 2008, THIS PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT AND CONTRALATERAL LEG COMPONENT. ON (B)(6), 2010, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY AN ILIAC EXTENDER COMPONENT WAS IMPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED.
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 | WLG325 | 05643559 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R | (B)(4) |