FDA Adverse Event
Injury
Summary report: N
OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 3923371
·
Received July 9, 2014
Report
- Report Number
- 3008011247-2014-00045
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- June 11, 2014
- Report Date
- June 11, 2014
- Manufacturer
- TRIVASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P120006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2014. THE AORTIC BODY AND ILIAC LIMB STENT GRAFTS WERE POSITIONED AND DEPLOYED AS EXPECTED. A REVIEW OF THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK WHICH WAS NOT RESOLVED WITH BALLOONING AND STENTING. THE PHYSICIAN ELECTED TO MONITOR THE ENDOLEAK UNTIL THE ONE MONTH FOLLOW-UP. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL SEQUELAE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400910 | OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM | ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM | MIH | TRIVASCULAR, INC. | TV-AB2980-E | FS030814-12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other | PALMAZ STENT |