FDA Adverse Event
Injury
Summary report: N
OVATION ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 3954986
·
Received July 24, 2014
Report
- Report Number
- 3008011247-2014-00052
- Event Type
- Injury
- Date Received
- July 24, 2014
- Date of Event
- June 24, 2014
- Report Date
- June 24, 2014
- Manufacturer
- TRIVASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P120006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REMAINS IMPLANTED.
Description of Event or Problem · 1
THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2011. THE PATIENT RETURNED ON (B)(6) 2014 AT THE FOLLOW-UP VISIT SHOWING THE PRESENCE OF A TYPE IB ENDOLEAK DUE TO THE ILIAC LIMB BECOMING DISENGAGED FROM THE COMMON ILIAC ARTERY. THE PHYSICIAN STATED THAT THE IMPLANTED ILIAC LIMB MAY HAVE BEEN TOO SHORT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL SEQUELAE REPORTED. A RE-INTERVENTION IS PLANNED FOR A LATER DATE TO TREAT THE ENDOLEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434391 | OVATION ABDOMINAL STENT GRAFT SYSTEM | ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM | MIH | TRIVASCULAR, INC. | TV-IL1412100-B | FS022311-09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other| R |