BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2873673 · Received December 14, 2012

    Report

    Report Number
    2029214-2012-00706
    Event Type
    Death
    Date Received
    December 14, 2012
    Date of Event
    June 5, 2011
    Report Date
    November 15, 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 DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE INTREPID CLINICAL DATABASE. TREATMENT OF A FUSIFORM BASILAR ANEURYSM. A TOTAL OF FIVE PIPELINES WERE USED. POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD UNEASINESS AND APHASIA. SUBSEQUENTLY, THE PATIENT EXPIRED ON (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death