FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1984589
·
Received February 2, 2011
Report
- Report Number
- 2017233-2011-00055
- Event Type
- Injury
- Date Received
- February 2, 2011
- Date of Event
- September 13, 2010
- Report Date
- February 2, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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. PLEASE NOTE ADD'L DEVICES INVOLVED: TG2610/06225368 AND TG2610/05501530. TG2610/06225368 AND TG2610/05501530 WERE REPORTED ON MEDWATCH # 2017233-2011-00054.
Description of Event or Problem · 1
ON (B)(6) 2009, THIS PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS AND GORE TAG THORACIC ENDOPROSTHESES TO TREAT A THORACIC AORTIC ANEURYSM. ON (B)(6) 2010, THE DEVICES WERE EXPLANTED DUE TO A PNEUMO AORTIC FISTULA. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
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 | 06627489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R |