BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE ASSURANT BILIARY STENT SYSTEM

    MDR report key: 457841 · Received May 2, 2003

    Report

    Report Number
    2953200-2003-01081
    Event Type
    Malfunction
    Date Received
    May 2, 2003
    Date of Event
    December 10, 2002
    Report Date
    December 10, 2002
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    FGE
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN 8 MM DIAMETER X 30 MM LENGTH BRIDGE ASSURANT BILIARY STENT WAS IMPLANTED IN A PATIENT FOR TREATMENT OF AN ILIAC ARTERY LESION IN 2002. PERCENT LESION STENOSIS AND VESSEL MORPHOLOGY ARE UNKNOWN. IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO PASS THROUGH A 6 F TF INPUT SHEATH. THE STENT WAS SUCCESSFULLY POSITIONED AND DEPLOYED. AFTER DEPLOYMENT, THE BALLOON WAS VERY SLOW TO DEFLATE, TAKING APPROXIMATELY 3 MINUTES TO COMPLETELY DEFLATE. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS REPORTED TO BE FINE. ANALYSIS OF THE RETURNED STENT DELIVERY SYSTEM HAS BEEN COMPLETED. THE STENT AND THE 6 F SHEATH WERE NOT RETURNED. FOOTPRINTS WERE NOTED ON THE BALLOON, AND THE BALLOON APPEARS TO HAVE BEEN INFLATED. THERE WERE 3 KINKS ON THE CATHETER, AND THERE APPEARED TO BE AXIAL COMPRESSION FAILURE UNDERNEATH THE STRAIN RELIEF AT THE ADHESIVE LINE. THE BALLOON WAS INFLATED WITHOUT DIFFICULTY, AND WAS DEFLATED WITHIN 13 SECS, WHICH IS WITHIN SPECS OF LESS THAN 25 SECS. BASED ON THE INVESTIGATION PERFORMED AND WITHOUT RETURN OF THE 6 F SHEATH, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE COMPLAINT OF INSERTION DIFFICULTIES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIDGE ASSURANT BILIARY STENT SYSTEM PERIPHERAL STENT SYSTEM FGE MEDTRONIC AVE PERIPHERAL DIVISION NA 2G26E23

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other 6 F TF INPUT SHEATH.