FDA Adverse Event
Malfunction
Summary report: N
FLAIR ENDOVASCULAR STENT GRAFT
MDR report key: 4092411
·
Received September 5, 2014
Report
- Report Number
- 2020394-2014-00406
- Event Type
- Malfunction
- Date Received
- September 5, 2014
- Date of Event
- August 11, 2014
- Report Date
- August 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 DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEPLOYMENT OF AN ENDOVASCULAR STENT GRAFT IN A PSEUDOANEURYSM, THE STENT GRAFT COULD ONLY BE PARTIALLY DEPLOYED. ADDITIONAL FORCE WAS APPLIED TO THE DELIVERY SYSTEM AND THE OUTER CATHETER BROKE NEAR THE DEPLOYMENT HANDLE. THE STENT GRAFT DEPLOYMENT WAS COMPLETED BY MANUAL RETRACTION OF THE OUTER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 545996 | FLAIR ENDOVASCULAR STENT GRAFT | MIH | BARD PERIPHERAL VASCULAR, INC. | ANYC1999 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |