BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 9836787 · Received March 16, 2020

    Report

    Report Number
    2029214-2020-00235
    Event Type
    Death
    Date Received
    March 16, 2020
    Date of Event
    May 1, 2015
    Report Date
    March 16, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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

    OGUZ S, TABAKCI ÖN, UYSAL E, BULUT E, DINÇ H. PIPELINE FLEX EMBOLIZATION DEVICE (PED FLEX) FOR THE TREATMENT OF INTRACRANIAL ANEURYSMS: PERIPROCEDURAL OUTCOMES AND FIRST-YEAR ANGIOGRAPHIC RESULTS. TURKISH JOURNAL OF MEDICAL SCIENCES. 2019;49(6):1640. HTTP://SEARCH .EBSCOHOST.COM/LOGIN.ASPX?DIRECT=TRUE & DB=EDB & AN=140821945 & SITE=EDS-LIVE. ACCESSED MARCH 16, 2020. MEDTRONIC RECEIVED A REPORT REGARDING A STUDY TO EVALUATE THE EFFICACY OF THE PIPELINE FLEX DEVICE. THE AUTHORS REVIEWED 49 PATIENTS WITH A MEAN AGE OF 52 YEARS, 63% FEMALE. THE AVERAGE ANEURYSM DIAMETER WAS 8MM. THE MORBIDITY RATE WAS 0% AND THE MORTALITY RATE WAS 4.3% WHICH WAS NTOED TO HAVE BEEN DUE TO COMPLICATIONS OF FEMORAL ARTERY ACCESS AND SUBARACHNOID HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300076 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK FLEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death