BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3073635 · Received April 23, 2013

    Report

    Report Number
    2029214-2013-00390
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE MARKSMAN CATHETER AND THE SNARE WAS RETURNED FOR EVALUATION. NO DAMAGE WAS FOUND ON THE CATHETER. THE CATHETER WAS FLUSHED AND THE LUMEN WAS FOUND CLEAR.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT SUPERIOR HYPOPHYSEAL SACCULAR ANEURYSM MEASURING 5MM X 4MM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE DISTAL WIRE FRACTURED AS THE PHYSICIAN TORQUED THE WIRE A TOTAL OF THREE TIMES IN AN ATTEMPT TO DETACH IT DISTALLY. THE MARKSMAN CATHETER WAS USED TO PUSH OFF THE DISTAL WIRE AND OPEN THE PIPELINE DISTALLY. THE FRACTURED WIRE WAS RETRIEVED WITH A SNARE.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174337 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-10 9612135

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention| S