FDA Adverse Event
Malfunction
Summary report: N
FLAIR ENDOVASCULAR STENT GRAFT
MDR report key: 3973231
·
Received June 6, 2014
Report
- Report Number
- 2020394-2014-00252
- Event Type
- Malfunction
- Date Received
- June 6, 2014
- Date of Event
- May 5, 2014
- Report Date
- May 13, 2014
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- MIH
- PMA / PMN Number
- P060002
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A VASCULAR STENT GRAFT ONLY PARTIALLY DEPLOYED AND ADDITIONAL ATTEMPTS TO COMPLETE THE DEPLOYMENT WERE UNSUCCESSFUL. THE STENT GRAFT AND DEPLOYMENT SYSTEM WERE REMOVED AND A NEW STENT GRAFT WAS DEPLOYED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331420 | FLAIR ENDOVASCULAR STENT GRAFT | MIH | BARD PERIPHERAL VASCULAR, INC. | ANXF2408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |