BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE PLATINUM

    MDR report key: 8503050 · Received April 11, 2019

    Report

    Report Number
    8503050
    Event Type
    Death
    Date Received
    April 11, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 10, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    NRY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELDERLY FEMALE WITH PROXIMAL RIGHT MIDDLE CEREBRAL ARTERY OCCLUSION WAS BROUGHT INTO PROCEDURE ROOM FOR MECHANICAL THROMBECTOMY. A SOLITAIRE 4X40 WAS ADVANCED INTO THE RIGHT MIDDLE CEREBRAL ARTERY WHERE IT WAS DEPLOYED. THE STENT DETACHED. AN ANGIOGRAM WAS OBTAINED VIA THE GUIDING CATHETER DEMONSTRATED AN OCCLUSION OF THE INTERNAL CAROTID ARTERY WITH A RETAINED STENT. ATTEMPTS TO RETRIEVE THE STENT AND ASPIRATE CLOT USING OTHER METHODS WERE UNSUCCESSFUL, AND THE PROCEDURE WAS STOPPED. THE PATIENT WAS SENT BACK TO THE ICU. THE FOLLOWING DAY A HEAD CT SHOWED ENLARGEMENT OF THE INFARCT, BUT NO BLEEDING. THE FAMILY MADE THE PATIENT A DNR/DNI AND TRANSITIONED HER TO COMFORT CARE. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295969 SOLITAIRE PLATINUM CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. SFR3-4-40-10 A632125

    Patients

    Seq Age Sex Outcome Treatment
    1 30295 DA Death| L