BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM

    MDR report key: 2946292 · Received February 6, 2013

    Report

    Report Number
    2134265-2013-00362
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K032884
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS.(B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2013-00360. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOGRAPHY (PTCA) PROCEDURE, THE DEVICE WAS REMOVED WITHOUT THE RETRIEVAL SHEATH. THE 90% STENOSED LESION WAS LOCATED IN THE TORTUOUS DIFFUSE DISEASED RIGHT GRAFT. A FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM WAS IN PLACE. A 4.0 X 24MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED IN THE RIGHT GRAFT. DURING THE ATTEMPT TO RETRIEVE THE OCCLUDED FILTER WIRE EZ WITH THE RETRIEVAL SHEATH, THE PROXIMAL END OF THE STENT ACCORDIONED. THERE WAS "GREAT DIFFICULTY" GETTING ANYTHING BACK THRU THE STENT CAUSING SLOW FLOW AND NO RE-FLOW IN THE VESSEL. FINALLY THE FILTER WAS SUCCESSFULLY PULLED OUT WITHOUT THE RETRIEVAL SHEATH AND FLOW WAS REGAINED. ANOTHER STENT WAS IMPLANTED TO RESOLVE THE DEFORMATION ISSUE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51168 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE UNK523

    Patients

    Seq Age Sex Outcome Treatment
    1 Other