FDA Adverse Event
Other
Summary report: N
OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 3556948
·
Received December 23, 2013
Report
- Report Number
- 3008011247-2013-00063
- Event Type
- Other
- Date Received
- December 23, 2013
- Date of Event
- October 24, 2012
- Report Date
- November 27, 2013
- Manufacturer
- TRIVASCULAR, INC
- Product Code
- MIH
- PMA / PMN Number
- P120006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT UNDERWENT ENDOVASCULAR REPAIR OF AAA WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2012. BASED ON COMMUNICATION RECEIVED FROM THE SITE ON (B)(6) 2013, A TYPE IA ENDOLEAK WAS CONFIRMED ON (B)(6) 2013 USING ANGIOGRAPHY, AND THE SITE BELIEVES THAT A TYPE IA ENDOLEAK WAS PRESENT AT THE ONE MONTH, SIX MONTH, AND TWELVE MONTH ROUTINE F/U. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO REPORT OF A RE-INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672571 | OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM | ENDOVASCULAR GRAFT, AORTIC ANEURYSM | MIH | TRIVASCULAR, INC | TV-AB2980-D | FS050712-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |