FDA Adverse Event
Malfunction
Summary report: N
FLAIR ENDOVASCULAR STENT GRAFT
MDR report key: 2050527
·
Received March 15, 2011
Report
- Report Number
- 2020394-2011-00050
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- November 12, 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
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS ARE CURRENTLY BEING REVIEWED. THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT APPROXIMATELY 15 MONTHS POST-IMPLANT, THE PT PRESENTED WITH A THROMBOSED AV FISTULA AND SEVERE STENOSIS WITHIN A STENT GRAFT IN THE BASILIC AXILLARY VEIN JUNCTION. THROMBOLYSIS, THROMBECTOMY AND ANGIOPLASTY WERE PERFORMED ON THE FISTULA AND PTA WAS PERFORMED IN THE STENT GRAFT. AT THE END OF THE COMPLETION OF THE PROCEDURE, THE AXILLARY ARTERY, SUBCLAVIAN ARTERY, AND CENTRAL VENOUS OUTFLOW APPEARED WIDELY PATENT. HOWEVER, IT WAS REPORTED THAT FLOW WITHIN THE FISTULA WAS NOT LIKELY TO BE ADEQUATE FOR DIALYSIS. THE PT TOLERATED THE PROCEDURE AND CONTINUES TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLAIR ENDOVASCULAR STENT GRAFT | MIH | BARD PERIPHERAL VASCULAR, INC. | ANTA0813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | ASA| HEPARIN| PLAVIX |