FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2893944
·
Received December 19, 2012
Report
- Report Number
- 2017233-2012-00854
- Event Type
- Injury
- Date Received
- December 19, 2012
- Date of Event
- December 3, 2012
- Report Date
- December 3, 2012
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MFG RECORDS REVIEW VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6), 2012, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. NO COMPLICATIONS WERE NOTED AT THAT TIME. THE PT LATER PRESENTED WITH A RUPTURED ANEURYSM, AND THE PHYSICIAN DIAGNOSED A DISTAL TYPE I ENDOLEAK, SECONDARY TO AN INFECTION ON ANOTHER MFR'S DEVICE. ON (B)(6) 2012, THE PT UNDERWENT A PROCEDURE TO ADDRESS THE ENDOLEAK WITH AN ILIAC EXTENDER.
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 | 10259528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R | CYMBALTA| NIACIN| VICODIN| ATENOLOL| DITROPAN |