BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2862931 · Received December 10, 2012

    Report

    Report Number
    2029214-2012-00704
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WAS RETURNED FOR EVALUATION AND THE BRAIDS WERE FOUND TO BE DAMAGED, BUT THE CAUSE COULD NOT BE DETERMINED.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANTERIOR COMMUNICATING ARTERY (A-COMM) ANEURYSM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE DEVICE WOULD NOT RELEASE FROM THE CAPTURE COIL, SO IT WAS CORKED AND REMOVED FROM THE PATIENT. THE PHYSICIAN USED ANOTHER PIPELINE IN ITS PLACE TO COMPLETE THE PROCEDURE.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77250-10 9638505

    Patients

    Seq Age Sex Outcome Treatment
    1