BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2950022 · Received February 8, 2013

    Report

    Report Number
    2029214-2013-00116
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE PIPELINE WAS FOUND DAMAGED WITH CLOTTED BLOOD AT ONE END WHICH LIKELY PREVENTED THE DEVICE FROM FULLY OPENING.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A RIGHT UNRUPTURED CAVERNOUS (CAV) ANEURYSM MEASURING 16MM X 8MM. DURING PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE DEVICE TWISTED AND WAS NOT DEPLOYED PROPERLY. IT WAS CORKED AND REMOVED FROM THE PATIENT.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55088 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71450-30 9650856

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR