BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3109822 · Received May 13, 2013

    Report

    Report Number
    2029214-2013-00427
    Event Type
    Death
    Date Received
    May 13, 2013
    Report Date
    April 22, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENTS WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENTS. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE, "CANADIAN EXPERIENCE WITH THE PIPELINE EMBOLIZATION DEVICE FOR REPAIR OF UNRUPTURED INTRACRANIAL ANEURYSMS", AJNR AM J NEURORADIOL 2013 34: 381-387 ORIGINALLY PUBLISHED ONLINE ON AUGUST 2, 2012, THE MEAN AGE AT THE TIME OF TREATMENT WAS 56.5 YEARS. MOST PATIENTS WERE FEMALE. LARGE AND WIDE NECK ANEURYSM: DIAMETER 19MM (2-60MM), NECK WIDTH 8MM (2-25MM). DURING THE DEFINED STUDY PERIOD, IT WAS REPORTED THAT 97 CASES OF UNRUPTURED ANEURYSMS WERE TREATED WITH PIPELINES AND 94 CASES WERE SUCCESSFUL. MULTIVARIATE ANALYSIS FOUND FEMALE PATIENTS AND PATIENTS THAT HAVE PREVIOUSLY BEEN TREATED FOR ANEURYSM WERE PREDICTIVE OF PERSISTENT ANEURYSMS FOLLOWED THROUGH 1 YEAR. PATIENTS (88%) WITH CAVERNOUS CAROTID ANEURYSMS WERE STABLE OR IMPROVED WITH THE MOST FAVORABLE OUTCOMES. THE OVERALL MORTALITY RATE WAS 6%. POST PROCEDURAL ANEURYSM HEMORRHAGE OCCURRED IN 3 PATIENTS (3%), WHILE IPSILATERAL DISTAL TERRITORY HEMORRHAGE WAS OBSERVED IN 4 PATIENTS (3.4%)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211641 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR VARIOUS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| S