FDA Adverse Event
Injury
Summary report: N
FLAIR ENDOVASCULAR STENT GRAFT
MDR report key: 2121361
·
Received June 6, 2011
Report
- Report Number
- 2020394-2011-00126
- Event Type
- Injury
- Date Received
- June 6, 2011
- Date of Event
- February 24, 2011
- Report Date
- May 12, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P060002/S002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 PTA WAS PERFORMED TO TREAT A 70% STENOSIS WITHIN THE STENT GRAFT AT THE VENOUS ANASTOMOSIS. GOOD HEMODYNAMIC FUNCTION WAS RESTORED. 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. | ANUF0524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention | STERIOD| EYTHROPOIETIN (EPO)| HEPARIN| ASA| METHYLPREDNISOLONE |