FDA Adverse Event
Malfunction
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 3090107
·
Received April 19, 2013
Report
- Report Number
- 2017233-2013-00240
- Event Type
- Malfunction
- Date Received
- April 19, 2013
- Date of Event
- March 21, 2013
- Report Date
- March 21, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2013, THE PT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PT'S PROXIMAL AORTIC NECK MEASURED 15 MM IN DIAMETER, AND THE PHYSICIAN REPORTEDLY EXPECTED A PROXIMAL TYPE I ENDOLEAK DUE TO DEVICE INFOLDING TO OCCUR AS A RESULT OF THE SMALL NECK. AFTER A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM WAS IMPLANTED, ANGIOGRAPHY SHOWED EVIDENCE OF A PROXIMAL TYPE I ENDOLEAK, REPORTEDLY DUE TO DEVICE INFOLDING AT THE PROXIMAL NECK. IT WAS REPORTED THAT ADD'L ANGIOPLASTY WAS PERFORMED, BUT THE ENDOLEAK PERSISTED. THE PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE AND WILL CONTINUE TO MONITOR THE ENDOLEAK. AN INTERVENTION IS NOT PLANNED AT THIS TIME. NO ANEURYSM GROWTH WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 169502 | GORE EXCLUDER AAA ENDOPROSTHESIS | MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 10469026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | NITROGLYCERIN| MILK OF MAGNESIA| OMEPRAZOLE| SYNTHROID| TRAMADOL| NAMENDA| ASPIRIN| CRESTOR| PREMARIN| CITALOPRAM| ISOSORBIDE| PLAVIX| TOPROL| DETROL| TYLENOL |