BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3002443 · Received March 13, 2013

    Report

    Report Number
    2029214-2013-00238
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) ANEURYSM MEASURING 11MM X 6MM. DURING DEPLOYMENT OF THE SECOND PIPELINE, IT WAS REPORTED THAT IT ADVANCED TOO DISTALLY ACROSS THE ACA (ANTERIOR CEREBRAL ARTERY). UPON RETRIEVAL OF THE DEVICE, THE PHYSICIAN INADVERTENTLY DEPLOYED THE PIPELINE AND A BALLOON WAS USED TO ACHIEVE FULL WALL APPOSITION.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106136 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71425-30 9650405

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention