BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM PROTCT EMBOLIC EZ L 190CM-S32626449

    MDR report key: 20561537 · Received October 28, 2024

    Report

    Report Number
    MW5161826
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    September 9, 2024
    Report Date
    October 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EZ FILTER 3.5-5-EMBOLIC PROTECTION DEVICE DEPLOYED TO PROXIMAL PORTION OF SAPHENOUS VEIN GRAFT (SVG) TO RIGHT POSTEROLATERAL ARTERY (RPL). AFTER FILTER RETRIEVAL, NOTED DISTAL SEGMENT OF FILTER BASKET WAS SHEARED OFF OF THE DEVICE. REQUIRED CORONARY STENT PLACEMENT IN SVG TO OPEN THE VESSEL AND CRUSH THE DEBRIS ALONG THE WALL OF THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982971 SYSTEM PROTCT EMBOLIC EZ L 190CM-S32626449 TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC CORPORATION H749201001900

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male