BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 10508707 · Received September 9, 2020

    Report

    Report Number
    2029214-2020-00910
    Event Type
    Death
    Date Received
    September 9, 2020
    Date of Event
    May 5, 2013
    Report Date
    September 9, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SOIZE S., BARBE C., KADZIOLKA K., ESTRADE L., SERRE I., PIEROT L. PREDICTIVE FACTORS OF OUTCOME AND HEMORRHAGE AFTER ACUTE ISCHEMIC STROKE TREATED BY MECHANICAL THROMBECTOMY WITH A STENT-RETRIEVER.NEURORADIOLOGY. 2013;55(8):977-987. DURING THE STUDY PERIOD, 59 CONSECUTIVE PATIENTS (27 MALE AND 32 FEMALES; MEAN AGE 63±16 YEARS) WITH ACUTE OCCLUSION OF LARGE INTRAC EREBRAL ARTERIES UNDERWENT THROMBECTOMY WITH THE SOLITAIRE FR DEVICE. FORTY-THREE PATIENTS (72.9 %) RECEIVED INTRAVENOUS THROMBOLYSIS BEFORE THE ENDOVASCULAR THERAPY. AT 3 MONTHS, 34/59 PATIENTS (57.6 %) HAD A GOOD FUNCTIONAL OUTCOME (MRS 0¿2), 13 PATIENTS HAD A MODERATE FUNCTIONAL OUTCOME (22 %), AND 12 PATIENTS DIED (20.4 %).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974434 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE NOT-REP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death