FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1335565
·
Received March 3, 2009
Report
- Report Number
- 2017233-2009-00124
- Event Type
- Injury
- Date Received
- March 3, 2009
- Date of Event
- February 6, 2009
- Report Date
- March 2, 2009
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 SPECS. ALSO IMPLANTED IN THE PT AND MFG AT SITE 2953161 WAS A CONTRALATERAL LEG COMPONENT PXC141000.
Description of Event or Problem · 1
IN 2008, THIS PT UNDERWENT ENDOVASCULAR REPAIR USING GORE EXCLUDER AAA ENDOPROSTHESES. IMAGES TAKEN SEVEN MONTHS LATERSHOWED A POSSIBLE TYPE II ENDOLEAK. A FOLLOW-UP AORTOGRAM REVEALED A PROXIMAL TYPE I ENDOLEAK. A REINTERVENTION TOOK PLACE IN 2009, USING AN AORTIC EXTENDER COMPONENT. THE TYPE I ENDOLEAK RESOLVED AND THE PT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES | WLG325 | 05692544 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R |