BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 10021912 · Received May 4, 2020

    Report

    Report Number
    2029214-2020-00428
    Event Type
    Death
    Date Received
    May 4, 2020
    Report Date
    May 4, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    WANG Z, TIAN Z, LI W, ET AL. VARIATION OF MASS EFFECT AFTER USING A FLOW DIVERTER WITH ADJUNCTIVE COIL EMBOLIZATION FOR SYMPTOMATIC UNRUPTURED LARGE AND GIANT INTRACRANIAL ANEURYSMS. FRONTIERS IN NEUROLOGY. 2019;10:1. MEDTRONIC RECEIVED A REPORT THROUGH LITERATURE REGARDING PATIENT'S IMPLANTED WITH A PIPELINE DEVICE. THE REMAINING PATIENT DIED OF SUBARACHNOID HEMORRHAGE DIAGNOSED AT A LOCAL CENTER 2MONTHS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483870 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death| O