FDA Adverse Event
Malfunction
Summary report: N
FLAIR ENDOVASCULAR STENT GRAFT
MDR report key: 2050570
·
Received March 15, 2011
Report
- Report Number
- 2020394-2011-00048
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- December 27, 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
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT APPROXIMATELY TWELVE MONTHS POST-IMPLANT, THE ENDOVASCULAR STENT GRAFT WAS FOUND TO HAVE A STENOSIS WITHIN THE PROXIMAL END OF THE DEVICE. REPORTEDLY, THERE WAS LOW FLOW AND PROLONGED BLEEDING DURING DIALYSIS TREATMENTS. PTA OF THE STENT GRAFT WAS PERFORMED WITH NO RESIDUAL STENOSIS AT THE END OF THE PROCEDURE. 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. | ANTD1219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | COUMADIN| ERYTHROPOIETIN (EPO)| HEPARIN |