BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 1160545 · Received September 10, 2008

    Report

    Report Number
    9681442-2008-00142
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    JCT
    PMA / PMN Number
    K050832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MFG AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE SAMPLE HAS BEEN RETURNED AND THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO PLACE A STENT GRAFT INSIDE AN ARM LOOP GRAFT WITH AN ANEURYSM, THE STENT GRAFT WAS NOT PLACED CORRECTLY AS IT WAS DIFFICULT TO DEPLOY. A SECOND STENT GRAFT WILL BE PLACED FROM THE OTHER SIDE, TO CREATE A BRIDGE. A 9F INTRODUCER SHEATH AND AN ANGLED HYDROPHILLIC GLIDE WIRE WERE USED FOR THE PROCEDURE. THE DISTANCE TO THE LESION WAS APPROX 6MM. THERE WAS AN ANGLE AND BEND TO THE INTENDED SITE, BUT THE TRACKING VESSEL WAS NOT CALCIFIED. THERE WAS NO DIFFICULTY IN ADVANCING THE DELIVERY SYSTEM, BUT EXCESSIVE FORCE WAS NECESSARY TO START THE STENT GRAFT DEPLOYMENT AT THE LESION. NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT JCT ANGIOMED GMBH & CO. MEDIZINTECHNIK ANRL0553

    Patients

    Seq Age Sex Outcome Treatment
    1