BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 1060532 · Received June 11, 2008

    Report

    Report Number
    9681442-2008-00078
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 1, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTE
    Product Code
    JCT
    PMA / PMN Number
    K050832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WAS RETURNED AND EVALUATED. THE SAFETY CLIP WAS MISSING UPON RECEIPT OF THE SAMPLE. THE TUOHY BORST ADAPTER WAS OPENED AND THE 2-WAY STOP COCK WAS CLOSED. THE STENT WAS PARTLY RELEASED 15MM. THE OUTER SHEATH IS TORN OFF AT THE CATHETER REINFORCEMENT AND ELONGATED IN THAT AREA. THE COMPLAINT IS CONFIRMED. THE CONDITION OF SAMPLE LEADS TO CONCLUDE THAT THE SYSTEM WAS EXPOSED TO HIGH FRICTION FORCES DURING ADVANCEMENT IN THE VESSEL, FINALLY RESULTING IN THE DESCRIBED DEPLOYMENT DIFFICULTIES AND THE FRACTURE OF THE OUTER SHEATH. HOWEVER, BASED ON THE EVAL OF THE SAMPLE AND THE INFO PROVIDED, THE EXACT ROOT CAUSE FOR THE DAMAGE TO THE PRODUCT COULD NOT BE DETERMINED. THE APPLICATION REPRESENTS OFF-LABEL USE. THE FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT IS INDICATED FOR THE TREATMENT OF TRACHEOBRONCHIAL STRICTURES. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE FOR THE TREATMENT OF ANEURYSMS HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD A LOT OF DIFFICULTY ADVANCING THE FLUENCY INTO POSITION, AND WITH MORE THAN 3 ATTEMPTS IN ADVANCEMENT AND WITHDRAWAL THE OUTER CATHETER SHAFT SPLIT EXPOSING THE SPRING COIL SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT JCT ANGIOMED GMBH & CO. MEDIZINTE ANRJ1211

    Patients

    Seq Age Sex Outcome Treatment
    1