FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2893964
·
Received December 21, 2012
Report
- Report Number
- 2953161-2012-00215
- Event Type
- Injury
- Date Received
- December 21, 2012
- Date of Event
- November 7, 2012
- Report Date
- November 27, 2012
- 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
THE MFG RECORDS REVIEW VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICE: PXC201000/#8103745.
Description of Event or Problem · 1
ON (B)(6) 2012, THE PT UNDERWENT TREATMENT WITH GORE EXCLUDER AAA ENDOPROSTHESES FOR AN ABDOMINAL AORTIC ANEURYSM, AND AT THE END OF THE PROCEDURE THERE WAS A DISTAL TYPE I ENDOLEAK ON ONE OF THE CONTRALATERAL LEGS. ON (B)(6) 2012, ANOTHER CONTRALATERAL LEG WAS ADDED AS A DISTAL EXTENSION, RESOLVING THE ENDOLEAK. A CAUSE FOR THE ENDOLEAK WAS NOT DESCRIBED IN THE MEDICAL RECORDS.
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 | 9396014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Hospitalization| R | MIRALAX| METOPROLOL| MIRTAZAPINE| SIMVASTATIN| XALATAN| DETROL |