BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2902180 · Received January 8, 2013

    Report

    Report Number
    2029214-2013-00018
    Event Type
    Death
    Date Received
    January 8, 2013
    Date of Event
    March 26, 2012
    Report Date
    December 11, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6). TREATMENT OF A RIGHT UNRUPTURED INTERNAL CAROTID ARTERY (ICA) ANEURYSM MEASURING 29.8 MM X 10.2 MM. POST PIPELINE PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEADACHE AND CONSEQUENTLY EXPIRED DUE TO THE RUPTURE OF THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8778 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-20 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death