FDA Adverse Event
Malfunction
Summary report: N
FLAIR ENDOVASCULAR STENT GRAFT
MDR report key: 2050526
·
Received March 15, 2011
Report
- Report Number
- 2020394-2011-00051
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- November 24, 2010
- Report Date
- February 17, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P060002/S002
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS ARE CURRENTLY BEING REVIEWED. THE INVESTIGATION IS UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST STENT GRAFT IMPLANT, THE PT PRESENTED WITH AN ARTERIAL PSEUDOANEURYSM AND STENOSIS AT BOTH ENDS OF THE STENT GRAFT. ANGIOPLASTY WAS PERFORMED WITH SUCCESSFUL RESULTS. THERE WAS NO REPORT OF INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLAIR ENDOVASCULAR STENT GRAFT | MIH | BARD PERIPHERAL VASCULAR, INC. | ANSK2292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | ERYTHROPOIETIN (EPO) |