FDA Adverse Event
Death
Summary report: N
OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 5393845
·
Received January 27, 2016
Report
- Report Number
- 3008011247-2016-00007
- Event Type
- Death
- Date Received
- January 27, 2016
- Date of Event
- December 9, 2015
- Report Date
- December 29, 2015
- Manufacturer
- TRIVASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P120006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RELEASED FROM HOSPITAL.
Description of Event or Problem · 1
AN OVATION IX AORTIC BODY STENT GRAFT WITH OVATION PRIME ILIAC LIMB STENT GRAFTS WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AT THE CONCLUSION OF THE IMPLANT PROCEDURE. WITHIN 5 DAYS POST-OP, THE PATIENT PRESENTED WITH A STENOSIS OF THE SUPERIOR MESENTERIC ARTERY AND AN OCCLUSION OF THE RIGHT ILIAC LIMB STENT GRAFT. A THROMBECTOMY RE-INTERVENTION WAS PERFORMED TO SUCCESSFULLY RESOLVE THE STENOSIS AND THE OCCLUDED ILIAC LIMB. IT WAS REPORTED THAT THE PATIENT HAD POOR CARDIAC OUTPUT DURING THE RE-INTERVENTION AND DID NOT RECOVER FROM THE ANESTHESIA AND SUBSEQUENTLY EXPIRED 12 DAYS POST-OP. THE OFFICIAL CAUSE OF DEATH IS UNKNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50723 | OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM | ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM | MIH | TRIVASCULAR, INC. | TV-IL1410120-E | FS050214-24 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| R |