FDA Adverse Event
Malfunction
Summary report: N
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
MDR report key: 3030878
·
Received March 28, 2013
Report
- Report Number
- 9681442-2013-00032
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Date of Event
- March 4, 2013
- Report Date
- March 6, 2013
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
- Product Code
- JCT
- PMA / PMN Number
- K050832
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT HISTORY 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 THE MARKER BAND BECAME DISLODGED AND MOVED TO THE DISTAL AS A STENT GRAFT WAS BEING DEPLOYED. THE PT WAS REPORTED TO BE ASYMPTOMATIC AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127508 | FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT | JCT | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG | ANWK2644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |