BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 1120611 · Received August 13, 2008

    Report

    Report Number
    9681442-2008-00123
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Report Date
    July 18, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    JCT
    PMA / PMN Number
    K050832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 THE PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE SAMPLE WAS DISCARDED AT THE USER FACILITY, SO IT WAS NOT RETURNED FOR EVALUATION. THE RESULTS OF THE EVALUATION IS INCONCLUSIVE AND THE ROOT CAUSE IS UNK. THE APPLICATION REPRESENT AN OFF-LABELED 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 THE PHYSICIAN USED THE BASILIC VEIN AS THE SHEATHLESS APPROACH TO THE CEPHALIC VEIN. HE USED A 0.035 WIRE WITHOUT INCIDENT, AS THE TRACKING ANATOMY WAS NOT TORTUOUS OR CALCIFIED AND HE DID NOT MEET WITH RESISTANCE WHILE TRACKING TO THE TARGET LESION. HE WAS NOT ABLE TO DEPLOY THE STENT ONCE AT THE INTENDED SITE. WHEN THE DEVICE WAS REMOVED, THE CATHETER SHOWED SIGNS OF STRESS AT THE POINT OF CONNECTION WITH THE TOUHY. HE USED ANOTHER STENT GRAFT, SAME SIZE, FOR A SUCCESSFUL PROCEDURE AND 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 ANRH2614

    Patients

    Seq Age Sex Outcome Treatment
    1