FDA Adverse Event
Death
Summary report: N
OVATION IX ILIAC LIMB STENT GRAFT SYSTEM
MDR report key: 6176074
·
Received December 15, 2016
Report
- Report Number
- 3008011247-2016-00133
- Event Type
- Death
- Date Received
- December 15, 2016
- Date of Event
- August 23, 2016
- Report Date
- November 14, 2016
- Manufacturer
- TRIVASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P120006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REMAINS IMPLANTED.
Description of Event or Problem · 1
A PATIENT UNDERWENT AN EMERGENT EVAR WITH AN ACTIVE RUPTURE. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IIIA ENDOLEAK AT THE LEVEL OF THE LEFT ILIAC LIMB (AFX) AND ILIAC LIMB EXTENSION (OVATION). ONE DAY FOLLOWING THE PROCEDURE, THE PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 826506 | OVATION IX ILIAC LIMB STENT GRAFT SYSTEM | ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM | MIH | TRIVASCULAR, INC. | TV-EX222245-J | FS040416-27 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Death |