BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2935627 · Received January 30, 2013

    Report

    Report Number
    2029214-2013-00111
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    November 29, 2011
    Report Date
    January 23, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 INTREPED CLINICAL DATABASE. TREATMENT OF A LEFT UNRUPTURED INTERNAL CAROTID ARTERY (ICA) ANEURYSM MEASURING 5.3MM X 3.3MM. POST PIPELINE PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED VISUAL DISTURBANCE OF THE LEFT EYE DUE TO A STENOSIS OF THE PARENT ARTERY. IT WAS REPORTED THAT THE STENOSIS RESOLVED THE SAME DAY AS THE PROCEDURE WITHOUT ADDITIONAL TREATMENT OR MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40249 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77475-12 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Disability