BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ¿

    MDR report key: 2840612 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07157
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE RADIOPAQUE DISTAL TIP OF THE PROTECTION WIRE WAS FOUND CURVED. THE FILTER BAG WAS RETRACTED INTO THE DELIVERY SHEATH WITH 5 MM OF THE NOSECONE EXPOSED FROM THE DISTAL TIP OF THE DELIVERY SHEATH. BLOOD WAS FOUND ON THE INSIDE OF THE DELIVERY SHEATH. THE DISTAL PORTION WAS KINKED AT APPROXIMATELY 4.5 CM, AND AGAIN AT 123.5 CM TO 127 CM AT THE COREWIRE, WHEN MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. THE DELIVERY SHEATH WAS FOUND PARTIALLY PEELED AWAY FROM THE PROTECTION WIRE APPROXIMATELY AT 11.2 CM, WHEN MEASURED FROM THE EXIT PORT OF THE DELIVERY SHEATH. THE UNSHEATHING/SHEATHING TEST WAS PERFORMED SUCCESSFULLY. THE FILTER BAG WAS SUCCESSFULLY DEPLOYED AND THEN RETRACTED; THE FILTER BAG WAS OBSERVED TO BE IN GOOD CONDITION AND MET SPECIFICATION. THE PEEL AWAY TEST WAS PERFORMED SUCCESSFULLY, AND NO ANOMALIES WERE OBSERVED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID ARTERY INTERVENTION PROCEDURE A VASOSPASM OCCURRED. THE 90% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE INTERNAL CAROTID ARTERY (ICA). A 190CM FILTERWIRE EMBOLIC PROTECTION DEVICE WAS ADVANCED TO THE ICA AND WAS UNABLE TO BE DEPLOYED. THE FILTERWIRE WAS REMOVED AND WAS ABLE TO BE DEPLOYED OUTSIDE OF THE PATIENT. THE SAME FILTERWIRE WAS ADVANCED TO THE ICA, BUT WAS AGAIN UNABLE TO BE DEPLOYED AND AT THIS POINT A VASOSPASM OCCURRED. THE FILTERWIRE WAS ABLE TO BE REMOVED IMMEDIATELY, HOWEVER THE VASOSPASM CEASED AFTER ABOUT 30 MINUTES. NO ADDITIONAL INTERVENTION OR TREATMENT WAS GIVEN TO TREAT THE VASOSPASM. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID ARTERY INTERVENTION PROCEDURE A VASOSPASM OCCURRED. THE 90% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE INTERNAL CAROTID ARTERY (ICA). A 190CM FILTERWIRE EMBOLIC PROTECTION DEVICE WAS ADVANCED TO THE ICA AND WAS UNABLE TO BE DEPLOYED. THE FILTERWIRE WAS REMOVED AND WAS ABLE TO BE DEPLOYED OUTSIDE OF THE PATIENT. THE SAME FILTERWIRE WAS ADVANCED TO THE ICA, BUT WAS AGAIN UNABLE TO BE DEPLOYED AND AT THIS POINT A VASOSPASM OCCURRED. THE FILTERWIRE WAS ABLE TO BE REMOVED IMMEDIATELY, HOWEVER THE VASOSPASM CEASED AFTER ABOUT 30 MINUTES. NO ADDITIONAL INTERVENTION OR TREATMENT WAS GIVEN TO TREAT THE VASOSPASM. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ¿ TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE H749201001900 15281081

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other