BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERWIRE EZ EMBOLIC SYSTEM (3.5MM - 5.5MM)

    MDR report key: 1160945 · Received June 4, 2008

    Report

    Report Number
    2134265-2008-01577
    Event Type
    Malfunction
    Date Received
    June 4, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NTE
    PMA / PMN Number
    K032884
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2008-01576. CLINICAL TRIAL. IT WAS REPORTED THAT DURING A CAROTID STENTING PROCEDURE, THE TIP OF THE STENT DELIVERY DEVICE DISLODGED. THE TARGET LESION FOR THE PROCEDURE WAS LOCATED IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS DE NOVO, 90% STENOSED, AND MEASURED 4.5X15MM. THE LESION WAS NOT PREDILATED PRIOR TO TREATMENT. IT WAS REPORTED THAT ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY AND A 90CM 6F DESTINATION SHEATH WAS USED FOR ANGIOGRAPHY WHICH SHOWED A KINK IN THE SHEATH. THE SHEATH WAS REPORTEDLY PULLED BACK TO THE BASE OF THE PT'S NECK, WHICH STRAIGHTENED OUT THE KINK. A FILTERWIRE EZ EMBOLIC PROTECTION WIRE WAS PLACED PAST THE TARGET LESION AND A NEXSTENT WAS ADVANCED TO THE TARGET LESION, OVER THE FILTERWIRE. THE NEXSTENT WAS SUCCESSFULLY DEPLOYED AND POST DILATED RESULTING IN 10% RESIDUAL STENOSIS. WHEN THE PHYSICIAN ATTEMPTED TO RECAPTURE THE FILTERWIRE FOR REMOVAL, DIFFICULTIES WERE ENCOUNTERED AND THE DEVICE WAS REMOVED IN AN OPEN STATE. IT WAS REPORTED THAT THE DIFFICUTLIES ASSOCIATED WITH RECAPTURE WERE A RESULT OF THE TIP OF THE NEXTENT DELIVERY DEVICE REMAINING ON THE WIRE. THE PROCEDURE WAS COMPLETED WITH NO PT COMPLICATIONS. THE PT IS REPORTED TO BE FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ EMBOLIC SYSTEM (3.5MM - 5.5MM) NFA DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, NTE BOSTON SCIENTIFIC 20100-190 0810201

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR