FDA Adverse Event
Injury
Summary report: N
FLAIR ENDOVASCULAR STENT GRAFT
MDR report key: 2121347
·
Received June 6, 2011
Report
- Report Number
- 2020394-2011-00125
- Event Type
- Injury
- Date Received
- June 6, 2011
- Date of Event
- March 26, 2011
- Report Date
- May 12, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P060002/S002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE STENT GRAFT REMAINS IMPLANTED. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT TEN MONTHS AFTER STENT GRAFT PLACEMENT IN THE VENOUS ANASTOMOSIS OF AN AV ACCESS CIRCUIT, DECREASED DIALYSIS FLOWS WERE OBSERVED. STENOSES OF THE CENTRAL AND PERIPHERAL SECTIONS OF THE STENT GRAFT WERE SUCCESSFULLY TREATED WITH PTA AND GOOD HEMODYNAMIC FUNCTION WAS RESTORED. THERE WAS NO REPORT OF INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLAIR ENDOVASCULAR STENT GRAFT | MIH | BARD PERIPHERAL VASCULAR, INC. | ANTG2497 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | HEPARIN/ERYTHROPOIETIN (EPO) |