FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2221242
·
Received August 16, 2011
Report
- Report Number
- 2017233-2011-00424
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- June 16, 2011
- Report Date
- August 15, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2011, THIS PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN AORTIC ABDOMINAL ANEURYSM. ON (B)(6) 2011, A CT SCAN REVEALED A PROXIMAL TYPE I ENDOLEAK. A REINTERVENTION IS PLANNED FOR (B)(6) 2011.
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 | WLG425 | 8557397 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| R | DEJOXIN| ALOPEDERAL| WORFORIL| LOVASTATIN |