FDA Adverse Event
Death
Summary report: N
OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 4042464
·
Received August 27, 2014
Report
- Report Number
- 3008011247-2014-00064
- Event Type
- Death
- Date Received
- August 27, 2014
- Date of Event
- August 6, 2014
- Report Date
- August 18, 2014
- Manufacturer
- TRIVASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P120006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NOT AVAILABLE FOR RETURN.
Description of Event or Problem · 1
AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT DURING ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE, THE AORTIC BODY WAS POSITIONED AND DEPLOYED AS EXPECTED. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK WHICH WAS TREATED WITH IMPLANTATION OF A BALLOON EXPANDABLE STENT AND BALLOONING. THE PHYSICIAN BELIEVED THE ENDOLEAK HAD SUCCESSFULLY RESOLVED AND THEREFORE ELECTED NOT TO PERFORM A CONFIRMATION ANGIOGRAM. APPROXIMATELY TWO WEEKS FOLLOWING THE INDEX PROCEDURE, TRIVASCULAR WAS NOTIFIED THAT THE PATIENT HAD EXPIRED DUE TO A RUPTURED ANEURYSM. THE EXACT DATE OF DEATH IS UNKNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522123 | OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM | ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM | MIH | TRIVASCULAR, INC. | TV-AB2680-D | FS020314-11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Death | BALLOON EXPANDABLE STENT - 20MM |