BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4405513 · Received January 9, 2015

    Report

    Report Number
    2029214-2015-00036
    Event Type
    Death
    Date Received
    January 9, 2015
    Report Date
    December 12, 2014
    Manufacturer
    COVIDIEN
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE IMPLANTED IN THE PATIENT; THEREFORE, THE EVENT CAUSES COULD NOT BE DETERMINED. THE OTHER DEVICES INVOLVED IN THE OTHER EVENTS ARE AS FOLLOWS: (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: RAYCHEV R, TATESHIMA S, VINUELA F, ET AL. ABSTRACT W MP31: THROMBOTIC AND HEMORRHAGIC COMPLICATIONS AFTER PIPELINE EMBOLIZATION - A PLATELET AGGREGATION AND TRANSCRANIAL (B)(6) STUDY. STROKE. 2014; 45: AWMP31 A TOTAL OF 46 CONSECUTIVE PATIENTS UNDERWENT 48 PIPELINE EMBOLIZATION PROCEDURES. ALL PATIENTS RECEIVED DOUBLE ANTIPLATELET THERAPY WITH CLOPIDOGREL 75MG AND ASPIRIN 325MG DAILY FOR AT LEAST 3 DAYS PRIOR TO THE PLANNED PROCEDURE. PLATELET AGGREGATION TESTING WAS PERFORMED IN 41 PROCEDURES. BASED ON THE INITIAL ADP % INHIBITION, PATIENTS WERE DIVIDED IN 3 GROUPS IN THE PRESENT STUDY: 1) POOR RESPONDERS: 50%, 2) SATISFACTORY RESPONDERS: 50-75%, AND 3) OVER-RESPONDERS: 75% SIX PATIENTS EXPERIENCED SYMPTOMATIC THROMBOTIC COMPLICATIONS AND 3 PATIENTS EXPERIENCED A SYMPTOMATIC ICH (INTRACEREBRAL HEMORRHAGE) WHICH OCCURRED IN A REMOTE VASCULAR TERRITORY IN REFERENCE TO THE TREATED ANEURYSM, ONE OF WHICH WAS FATAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21213 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| S