BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM

    MDR report key: 22913833 · Received August 28, 2025

    Report

    Report Number
    2124215-2025-60066
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    July 1, 2010
    Report Date
    August 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. EVENT DATE WAS ESTIMATED BASED ON THE EARLIEST PROCEDURE DATE NOTED IN THE LITERATURE ARTICLE. DETAILS OF THE EVENT, INCLUDING PRODUCT INFORMATION, WERE NOT PROVIDED TO BSC. BECAUSE THE PRODUCT LOT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) NUMBER AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NII, K., TSUTSUMI, M., MAEDA, H., AIKAWA, H., INOUE, R., ETO, A., SAKAMOTO, K., MITSUTAKE, T., HANADA, H., & KAZEKAWA, K. (2016). COMPARISON OF FLOW IMPAIRMENT DURING CAROTID ARTERY STENTING USING TWO TYPES OF ECCENTRIC FILTER EMBOLIC PROTECTION DEVICES. NEUROLOGIA MEDICO-CHIRURGICA, 56(12), 759-765. HTTPS://DOI.ORG/10.2176/NMC.OA.2016-0036.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT SOME PATIENTS WHO UNDERWENT A CAROTID ARTERY STENTING (CAS) PROCEDURE USING A FILTERWIRE EZ EXPERIENCED STROKES, TRANSIENT ISCHEMIC ATTACK (TIA), NEUROLOGICAL EVENTS, ICA SPASMS, AND ICA FLOW IMPAIRMENT IMMEDIATELY AFTER ANGIOGRAPHY. THIS STUDY REVIEWED THE ANGIOGRAPHIC FINDINGS AND CLINICAL OUTCOMES OF 175 PATIENTS BETWEEN JULY 2010 AND AUGUST 2015 AFTER A CAROTID ARTERY STENTING (CAS) PROCEDURE USING A FILTERWIRE EZ OR THE SPIDER FX (NON-BOSTON SCIENTIFIC DEVICE) EMBOLIC PROTECTION DEVICES. IT WAS IDENTIFIED THAT THE PATIENTS THAT UNDERWENT A CAS PROCEDURE USING THE FILTERWIRE EZ EXPERIENCED THE FOLLOWING ADVERSE EVENTS: NEUROLOGIC EVENTS (5.8%), TIA (3.5%), MINOR STROKE (1.2%), MAJOR STROKE (1.2%), INTRAOPERATIVE DISTAL ICA SPASMS (30.2%), AND ICA FLOW IMPAIRMENT IMMEDIATELY AFTER ANGIOGRAPHY (10.5%). NO FURTHER INFORMATION WAS PROVIDED TO BOSTON SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519466 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other