FDA Adverse Event
Death
Summary report: N
OVATION IX ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 6227451
·
Received January 5, 2017
Report
- Report Number
- 3008011247-2017-00001
- Event Type
- Death
- Date Received
- January 5, 2017
- Date of Event
- December 7, 2016
- Report Date
- December 7, 2016
- Manufacturer
- TRIVASCULAR, INC.
- Product Code
- MIH
- UDI-DI
- M701TVAB3480J1
- PMA / PMN Number
- P120006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK THAT COULD NOT BE RESOLVED FOLLOWING THE PLACEMENT OF A BALLOON EXPANDABLE STENT. THE PATIENT PRESENTED APPROXIMATELY 20 DAYS POST-OP WITH ABDOMINAL PAIN. A CT COMPLETED SHOWED EVIDENCE OF AORTIC ANEURYSM ENLARGEMENT; THE PATIENT WAS CONVERTED TO OPEN SURGICAL REPAIR THE SAME DAY AND SUBSEQUENTLY EXPIRED DURING THE SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8604 | OVATION IX ABDOMINAL STENT GRAFT SYSTEM | ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM | MIH | TRIVASCULAR, INC. | TV-AB3480-J | FS032816-01 | M701TVAB3480J1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| R | SURGICAL CONVERSION |