BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2924272 · Received January 22, 2013

    Report

    Report Number
    2029214-2013-00068
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 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 A LEFT UNRUPTURED SUPERIOR HYPOPHYSEAL ANEURYSM MEASURING 6.50MM X 6.00MM. POST PIPELINE DEPLOYMENT, IT WAS REPORTED THAT A HYPERFORM BALLOON WAS USED TO ACHIEVE FULL WALL APPOSITION (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE). NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28953 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77450-20 9667555

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention