BEUDAMED
    FDA Adverse Event Death Summary report: N

    EV3, INC.

    MDR report key: 3522509 · Received November 19, 2013

    Report

    Report Number
    3522509
    Event Type
    Death
    Date Received
    November 19, 2013
    Date of Event
    November 6, 2013
    Report Date
    November 19, 2013
    Manufacturer
    EV3, INC.
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE ANGIOGRAM AND STENT OF THE RIGHT ILIAC ARTERY, THE BALLOON RUPTURED. THE BALLOON WAS NOT ABLE TO BE RETRIEVED PERCUTANEOUSLY AND THE PT WAS SENT TO THE OPERATING ROOM FOR REMOVAL OF THE DEVICE. A SHORT TIME LATER, THE PT WENT INTO HYPOTENSIVE SHOCK AND EVENTUALLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598718 EV3, INC. EVERCROSS DILATATION CATHETER LIT EV3, INC. AB35W10060135 9523598

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R