FDA Adverse Event
Other
Summary report: N
OVATION ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 3593242
·
Received January 15, 2014
Report
- Report Number
- 3008011247-2014-00005
- Event Type
- Other
- Date Received
- January 15, 2014
- Date of Event
- February 5, 2013
- Report Date
- December 19, 2013
- Manufacturer
- TRIVASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P120006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT UNDERWENT ENDOVASCULAR REPAIR OF AAA WITH THE OVATION ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2012. THE PT RETURNED FOR A ROUTINE SIX MONTH FOLLOW-UP ON (B)(6) 2013 AND PRESENTED WITH A POTENTIAL TYPE III ENDOLEAK. THE POTENTIAL TYPE III ENDOLEAK IS PRESENT AT THE ROUTINE TWELVE MONTH FOLLOW-UP ON (B)(6) 2013. AS OF THE DATE OF THIS REPORT, THERE IS NO PLANNED RE-INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41282 | OVATION ABDOMINAL STENT GRAFT SYSTEM | ENDOVASCULAR GRAFT, AORTIC ANEURYSM | MIH | TRIVASCULAR, INC. | TV-AB2380-B | FS082610-29 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |