BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2972780 · Received February 21, 2013

    Report

    Report Number
    2029214-2013-00152
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 AN ANEURYSM MEASURING 4MM X 2.50MM. POST PIPELINE DEPLOYMENT, IT WAS REPORTED THAT A BALLOON WAS REQUIRED TO ACHIEVE FULL WALL APPOSITION (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE).NO INJURY WAS REPORTED WITH PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75929 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-16 9672327

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention