FDA Adverse Event
Other
Summary report: N
OVATION ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 3303092
·
Received August 15, 2013
Report
- Report Number
- 3008011247-2013-00025
- Event Type
- Other
- Date Received
- August 15, 2013
- Date of Event
- July 8, 2013
- Report Date
- July 18, 2013
- Manufacturer
- TRIVASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P120006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2012. ON (B)(6) 2013, TRIVASCULAR WAS NOTIFIED OF A POTENTIAL ENDOLEAK IDENTIFIED DURING ROUTINE FOLLOW-UP IMAGING. A REVIEW OF THE FOLLOW-UP IMAGING (DATED (B)(6) 2013), CONFIRMED THE PRESENCE OF A TYPE II ENDOLEAK FROM THE LUMBARS WHICH IS NOT DEVICE-RELATED; HOWEVER, A POTENTIAL TYPE III ENDOLEAK AT THE JUNCTION OF THE LEFT PRIMARY ILIAC LIMB GRAFT AND ILIAC LIMB GRAFT EXTENSION WAS ALSO IDENTIFIED. THIS POTENTIAL TYPE III ENDOLEAK IS THE SUBJECT OF THIS REPORT AND COMPLAINT INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393439 | OVATION ABDOMINAL STENT GRAFT SYSTEM | ENDOVASCULAR GRAFT, AORTIC ANEURYSM | MIH | TRIVASCULAR, INC. | TV-AB2980-B | FS101810-41 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Other |