FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1873061
·
Received October 14, 2010
Report
- Report Number
- 2017233-2010-00453
- Event Type
- Injury
- Date Received
- October 14, 2010
- Date of Event
- December 10, 2005
- Report Date
- October 13, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2005, THE PATIENT WAS IMPLANTED WITH THE GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2005, AN AORTIC EXTENDER COMPONENT WAS IMPLANTED TO TREAT A PROXIMAL TYPE I ENDOLEAK. AT AN UNKNOWN DATE, THE PATIENT UNDERWENT A REINTERVENTION FOR AN EMBOLIZATION. ON (B)(6), 2010, ANEURYSM ENLARGEMENT WAS NOTED FROM AN UNKNOWN SOURCE. THE PHYSICIAN IS CURRENTLY MONITORING THE PATIENT.
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 | 03691126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| R |