BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 1011938 · Received March 11, 2008

    Report

    Report Number
    9681442-2008-00027
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 14, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    JCT
    PMA / PMN Number
    K050832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE SAMPLE HAS NOT BE RETURNED FOR EVALUATION TO DATE. BASED ON THE INFORMATION RECEIVED, THE COMPLAINT IS INCONCLUSIVE AND THE ROOT CAUSE IS UNKNOWN. THIS APPLICATION REPRESENTS AN OFF-LABEL USE. THE 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 DURING A STENTING PROCEDURE FOR A PSEUDOANEURYSM, IN A LEFT UPPER ARM AV GRAFT, THE DEVICE DID NOT DEPLOY. THE PROCEDURE WAS DONE SHEATHLESS, USING A 0.035 GLIDE WIRE. THE DOCTOR DID NOT HAVE ANY DIFFICULTY ADVANCING TO THE INTENDED SITE AND THE PATH WAS NOT TORTUOUS. THE SYSTEM WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT DIFFICULTY. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT JCT ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANPI2637

    Patients

    Seq Age Sex Outcome Treatment
    1