FDA Adverse Event
Malfunction
Summary report: N
FLAIR ENDOVASCULAR STENT GRAFT
MDR report key: 3812422
·
Received April 18, 2014
Report
- Report Number
- 2020394-2014-00173
- Event Type
- Malfunction
- Date Received
- April 18, 2014
- Date of Event
- February 28, 2014
- Report Date
- March 3, 2014
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P060002
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS A RE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE, THE DEPLOYMENT MECHANISM WAS UNABLE TO DEPLOY THE STENT GRAFT; THEREFORE, THE STENT GRAFT WAS EXCHANGED OVER THE GUIDE WIRE FOR A NEW STENT GRAFT THAT WAS PREPPED AND DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238909 | FLAIR ENDOVASCULAR STENT GRAFT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | BARD PERIPHERAL VASCULAR, INC. | ANXF1842 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female |