FDA Adverse Event
Malfunction
Summary report: N
FLAIR ENDOVASCULAR STENT GRAFT
MDR report key: 2050528
·
Received March 15, 2011
Report
- Report Number
- 2020394-2011-00049
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- December 28, 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
- DE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE DEVICE REMAINED IMPLANTED. THE INVESTIGATION IS UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT APPROXIMATELY SIXTEEN MONTHS POST-IMPLANT, THE PT PRESENTED WITH A THROMBOTIC OCCLUSION WITHIN THE ENDOVASCULAR STENT GRAFT. THROMBOLYSIS, THROMBECTOMY, AND ANGIOPLASTY WERE PERFORMED WITH EXCELLENT 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. | ANTB1431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | ERYTHROPOIETIN (EPO)| HEPARIN/ASA |