FDA Adverse Event
Injury
Summary report: N
OVATION ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 3885044
·
Received June 19, 2014
Report
- Report Number
- 3008011247-2014-00035
- Event Type
- Injury
- Date Received
- June 19, 2014
- Date of Event
- April 22, 2014
- Report Date
- May 22, 2014
- Manufacturer
- TRIVASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P120006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REMAINS IMPLANTED.
Description of Event or Problem · 1
THE SUBJECT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. THE 12 MONTH FOLLOW-UP CT SHOWS THE PRESENCE OF A TYPE IA ENDOLEAK DUE TO THE AORTIC DIAMETERS AT THE LEVEL OF THE PROXIMAL SEAL ZONE BEING OUTSIDE THE TREATMENT RANGE FOR A 34MM AORTIC BODY GRAFT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL SEQUELAE REPORTED AND THERE IS NO PLANNED RE-INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361957 | OVATION ABDOMINAL STENT GRAFT SYSTEM | ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM | MIH | TRIVASCULAR, INC. | TV-AB3480-B | FS072811-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |