BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 1024278 · Received March 27, 2008

    Report

    Report Number
    9681442-2008-00035
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    JCT
    PMA / PMN Number
    K050832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 SAFETY CLIP WAS MISSING. THE TUOHY BORST ADAPTER AND 2-WAY STOP COCK WERE OPEN. THE STENT GRAFT HAD BEEN PARTIALLY RELEASED FOR 12MM. THE OUTER SHEATH WAS ELONGATED AT THE CATHETER REINFORCEMENT. THE INNER CATHETER AND FILLING MATERIAL PROTRUDE 20MM FROM THE OUTER SHEATH. A FLUSHING TEST WAS PERFORMED SUCCESSFULLY FROM THE PIN VISE HANDLE (REAR) BUT WAS NOT SUCCESSFUL FROM THE 2-WAY STOP COCK (TOP). DURING THE ATTEMPT TO RELEASE THE STENT GRAFT, THE OUTER SHEATH TORE OFF. 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, WHICH MAY HAVE RESULTED IN THE DESCRIBED DEPLOYMENT DIFFICULTIES. HOWEVER, BASED ON THE EVALUATION OF THE SAMPLE AND THE INFORMATION RECEIVED, THE EXACT ROOT CAUSE FOR THE DAMAGE TO THE PRODUCT COULD NOT BE DETERMINED. 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 A STENT STARTED TO DEPLOY AND THEN JAMMED. IT HAD DEPLOYED APPROXIMATELY 2CM. THE DOCTOR REMOVED THE DEVICE AND USED ANOTHER FOR A SUCCESSFUL COMPLETION. THE INTENDED SITE WAS THE LEFT SFA, AND THE APPROACH USED WAS THE RIGHT. THIS WAS A CROSSOVER PROCEDURE, CONTRA LATERAL LEFT SFA USING AN 8F CROSSOVER SHEATH, UP AND OVER. THE GUIDEWIRE WAS .035 STIFF WIRE. THE EXACT DISTANCE OF THE TRACKING PATH IS NOT KNOWN, HOWEVER, IT WAS ALMOST TO THE KNEE. THERE WAS SOME CALCIFICATION PRESENT WHICH REQUIRED PREDILATION. THERE WERE NO DIFFICULTIES OR RESISTANCE IN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LESION. NO EXCESSIVE FORCE WAS USED WHEN TRYING TO DEPLOY THE DEVICE. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT JCT ANGIOMED GMBH & CO. MEDIZINTECHNIK ANQC1209

    Patients

    Seq Age Sex Outcome Treatment
    1