BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM

    MDR report key: 943138 · Received November 9, 2007

    Report

    Report Number
    2954755-2007-00044
    Event Type
    Injury
    Date Received
    November 9, 2007
    Date of Event
    October 12, 2007
    Report Date
    October 17, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NFA
    PMA / PMN Number
    K032884
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 6000093-2007-02136, SAME PATIENT AS MFR REPORT #: 2954755-2007-00043, 6000093-2007-02062. IT WAS REPORTED THAT 17 DAYS FOLLOWING A CAROTID ARTERY STENTING PROCEDURE, THE PATIENT EXPERIENCED A CVA (CEREBROVASCULAR ACCIDENT). ACCESS WAS OBTAINED VIA THE BRACHIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE DE NOVO, LEFT PROXIMAL INTERNAL CAROTID ARTERY WITH 85% STENOSIS, MEASURED 6.0X14MM, AND WAS DESCRIBED AS A COMPLEX LESION WITH BOTH CALCIUM AND SIGNIFICANT FIBROTIC PLAQUE ACCUMULATION. USING INTRAVASCULAR ULTRASOUND EVALUATION AND GUIDANCE, THE PATIENT UNDERWENT SUCCESSFUL BALLOON ANGIOPLASTY AND STENTING OF THE LEFT INTERNAL CAROTID ARTERY. FILTER WIRE DISTAL PROTECTION WAS USED. PRE-DILATATION WAS PERFORMED AND A NEXSTENT CAROTID STENT WAS PLACED. POST-DILATATION WAS PERFORMED TIMES TWO WITH 20-30% RESIDUAL STENOSIS FOLLOWING FIRST POST-DILATION AND 0-10% RESIDUAL STENOSIS FOLLOWING THE SECOND POST-DILATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH PNEUMONIA EIGHT DAYS FOLLOWING THE INDEX PROCEDURE. DURING THIS HOSPITALIZATION, 17 DAYS POST INDEX PROCEDURE, THE PATIENT DEVELOPED LEFT SIDED WEAKNESS AND WAS DIAGNOSED WITH A STROKE. CT EXAMINATIONS WERE PERFORMED AND REVEALED STABLE CT APPEARANCE WITH EVIDENCE OF PRIOR CVA BUT NO EVIDENCE FOR ACUTE INTRACRANIAL PATHOLOGY. CAROTID ULTRASOUND WAS PERFORMED AND REVEALED PATENT STENTS IN BOTH INTERNAL CAROTID ARTERIES. NEUROLOGY CONSULTATION IMPRESSION WAS LEFT-SIDED PURE MOTOR STROKE. THE OUTCOME EVENT WAS NOT RECOVERED/NOT RESOLVED. THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL THREE DAYS FOLLOWING THE CVA AND IS UNDER HOSPICE CARE. THE INVESTIGATOR REPORTED THE RELATIONSHIP OF THE NEXTSTENT AND FILTERWIRE EZ DEVICES TO THIS EVENT AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM NFA - CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY FOR EMBOLIZATION PROTECTIO NFA BOSTON SCIENTIFIC H749201001900 0000720503

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization