BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 1053479 · Received May 28, 2008

    Report

    Report Number
    9681442-2008-00071
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 16, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTE
    Product Code
    JCT
    PMA / PMN Number
    K050832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS NOT BEEN RETURNED FOR EVAL TO DATE. BASED ON THE INFO RECEIVED, THE RESULTS ARE INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT IS UNKNOWN. THIS APPLICATION REPRESENTS AN OFF-LABEL USE. FLUENCY TRACHEOBRONCHIAL STENT GRAFT IS INDICATED FOR USE IN THE TREATMENT OF TRACHEOBRONCHIAL STRICTURES AND HAS NEVER BEEN TESTED FOR AN APPLICATION AS DESCRIBED IN THIS CASE. THE CURRENT IFU SUPPLIED WITH THIS PRODUCT STATES THAT THE SAFETY AND EFFECTIVENESS OF THIS DEVICE FOR USE IN THE VASCULAR SYSTEM HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT GRAFT DEVICE FAILED TO DEPLOY IN A FISTULA IN THE LOWER ARM, JUST BELOW THE ELBOW. THE VESSEL HAD BEEN PREDILATED AND THEN THE PROCEDURE WAS DONE SHEATHLESS. THERE WAS NO CALCIFICATION NOTED IN THE VESSEL, BUT THE INTENDED SITE WAS AROUND A CORNER. THE DEVICE DID DEPLOY ABOUT HALF WAY BUT THEN THE PHYSICIAN MET WITH A LOT OF RESISTANCE, AND HE WAS CONCERNED IT MIGHT BREAK. HE REMOVED THE STENT AND COMPLETED THE PROCEDURE WITH ANOTHER STENT GRAFT WITHOUT ANY DIFFICULTY. ONCE THE PROCEDURE WAS COMPLETED, THE TECH TESTED THE ORIGINAL DEVICE ON THE BACK TABLE AND THE BLUE PART OF THE CATHETER ACTUALLY DID BREAK WHEN TRYING TO DEPLOY. THERE WAS NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT JCT ANGIOMED GMBH & CO. MEDIZINTE ANRE3133

    Patients

    Seq Age Sex Outcome Treatment
    1