BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS

    MDR report key: 1457712 · Received May 22, 2009

    Report

    Report Number
    9681442-2009-00055
    Event Type
    Malfunction
    Date Received
    May 22, 2009
    Date of Event
    April 29, 2009
    Report Date
    April 29, 2009
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    JCT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 STENT GRAFT REMAINS IMPLANTED AND THE DELIVERY SYSTEM HAS BEEN RETURNED; THE EVALUATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES 510(K) - K050832.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT GRAFT WAS IMPLANTED TO TREAT A RUPTURE IN THE SUBCLAVIAN VEIN. AFTER DEPLOYMENT, IT WAS OBSERVED THAT THE DELIVERY SYSTEM WAS DIFFICULT TO RETRACT. DURING RETRACTION, THE STENT GRAFT BECAME CAUGHT ON THE OUTER CATHETER AND THE STENT GRAFT WAS MOVED 5 TO 10 MM FROM ITS INITIAL IMPLANTATION SITE. WHEN THE DEPLOYMENT CATHETER WAS REMOVED, IT WAS NOTICED THAT THERE WAS A GAP IN THE SPRING COIL JUST PROXIMAL TO THE DISTAL TIP. THE STENT GRAFT REMAINED IN PLACE AND THE TARGET LESION WAS TREATED WITH TWO ADDITIONAL STENTS. THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS JCT ANGIOMED GMBH & CO. MEDIZINTECHNIK ANSA2910

    Patients

    Seq Age Sex Outcome Treatment
    1