BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2896758 · Received January 4, 2013

    Report

    Report Number
    2029214-2013-00002
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND THE PUSHWIRE WAS BROKEN INTO TWO SEGMENTS. ANALYSIS OF THE CROSS SECTION AT THE BREAK POINT SHOWED THE FAILURE OF THE PUSHWIRE OCCURRED DUE TO TORSIONAL OVERLOAD. THE PIPELINE WAS EXAMINED AND FOUND OPENING WITH THE DISTAL BRAIDS DAMAGED. PUSHWIRE SEPARATION. (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN WAS NOT ABLE TO REPOSITION THE PIPELINE BECAUSE THE CAPTURE COIL WAS STUCK IN THE VESSEL. THE PHYSICIAN DECIDED TO REMOVE THE PIPELINE, BUT THE PUSHER SEPARATED NEAR THE CAPTURE COIL. AN ATTEMPT TO REMOVE THE PIPELINE WITH AN ALLIGATOR RETRIEVAL DEVICE WAS MADE, BUT WAS NOT SUCCESSFUL. THE PHYSICIAN THEN TRIED TO OPEN THE DISTAL END OF THE PIPELINE WITH A HYPERGLIDE AND SCEPTOR BALLOON WITHOUT SUCCESS. THE PIPELINE WAS THEN REMOVED BY SURGICALLY OPENING THE VESSEL. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE AND WAS IN A PHARMACOLOGICAL COMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4607 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-20 9655049

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S