BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 7670552 · Received July 9, 2018

    Report

    Report Number
    2029214-2018-00607
    Event Type
    Death
    Date Received
    July 9, 2018
    Date of Event
    July 1, 2017
    Report Date
    October 5, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NATARAJAN, S, SHALLWANI, H, FENNELL, V, BEECHER, J, SHAKIR, H, DAVIES, J, SNYDER, K, SIDDIQUI, A, LEVY, E. FLOW DIVERSION AFTER ANEURYSMAL SUBARACHNOID HEMORRHAGE. CROSSMARK. 2017. 14 PAGES. 10.1016/J.NEC.2017.02.011 IN THIS ARTICLE 11 PATIENTS UNDERWENT ANEURYSM TREATMENT. 11 LOCATED IN THE ANTERIOR CIRCULATION, 3 IN THE POSTERIOR CIRCULATION. THE MEAN DIMENSION OF THE ANEURYSM WAS 5 MM. SHAPES SACCULAR IN 5, BLISTER IN 6, FUSIFORM IN 1, AND DISSECTING IN 2. ONE PATIENT EXPERIENCED IN-STENT THROMBUS WHICH RESOLVED COMPLETELY AFTER ADMINISTRATION OF A BOLUS OF EPTIFIBATIDE. ONE PATIENT CONTINUED TO HAVE AN EXTENSION OF SUBARACHNOID HEMORRHAGE AND INTRA-PARENCHYMAL HEMORRHAGE AFTER THE PROCEDURE. CONSEQUENTLY THE PATIENT DID NOT RECEIVE ANY ANTI-PLATELET THERAPY BEFORE OR AFTER THE PROCEDURE. PERIPROCEDURAL MORTALITY IN THE FIRST 30 DAYS WAS 18.2%, INDICATING THAT 2 PATIENTS HAD DIED. THE PATIENTS IN THE REMAINING CASES ACHIEVED GOOD FUNCTIONAL RECOVERY WITH MODIFIED RANKIN SCALE SCORES OF 0-2 AND 100% OBLITERATION OF THE ANEURYSM. PIPELINE STENOSIS WAS NOTED IN 1 CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512365 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| R