BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2924293 · Received January 22, 2013

    Report

    Report Number
    2029214-2013-00064
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 2, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    INFORMATION RECEIVED FROM THE (B)(6) DATABASE.TREATMENT OF A LEFT UNRUPTURED INTERNAL CAROTID (ICA) SIDEWALL ANEURYSM MEASURING 1.2MM X 6MM. POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEADACHES. A MAGNETIC RESONANCE SPECTROSCOPY (MRS) WAS DONE ON (B)(6) 2012 DUE TO THE HEADACHES.THE PATIENT'S CONDITION WAS REPORTED AS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29192 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77450-18 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Disability