BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3050474 · Received April 10, 2013

    Report

    Report Number
    2029214-2013-00346
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TREATMENT OF A LEFT UNRUPTURED CAV (CAVERNOUS) SACCULAR ANEURYSM MEASURING 17.2MM X 6 MM. DURING THE PROCEDURE, IT WAS REPORTED THAT TWO PIPELINES REQUIRED THE J WIRE TECHNIQUE TO RELEASE THEM FROM THEIR CAPTURE COILS.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.SAME EVENT AS MDR# 2029214-2013-00345.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148232 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77500-16 MA12-023

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Disability