FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2012543
·
Received February 28, 2011
Report
- Report Number
- 2953161-2011-00040
- Event Type
- Injury
- Date Received
- February 28, 2011
- Date of Event
- July 14, 2009
- Report Date
- February 28, 2010
- Manufacturer
- W. L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6), 2009, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6), 2009, THIS PT UNDERWENT A SECOND PROCEDURE WHERE AN ADDITIONAL AORTIC EXTENDER COMPONENT WAS IMPLANTED.
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 | 05644346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | (B)(4)| (B)(4)| (B)(4) |