BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3955690 · Received July 24, 2014

    Report

    Report Number
    2029214-2014-00416
    Event Type
    Death
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 LARGE PREVIOUSLY RUPTURED (WITHIN LAST 12 MONTHS, BUT FULLY RECOVERED) ANEURYSM MEASURING 12MM LOCATED IN THE RIGHT M1/M2 BIFURCATION. THE PATIENT'S ANATOMY WAS NORMAL IN TORTUOSITY. THE PATIENT'S PRU (P2Y12) LEVEL WAS BELIEVED TO BE 235. ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE PIPELINE (2.50MM X 16MM) WAS PLACED WITHIN THE M2 BRANCH THAT EXTENDED DOWN INTO THE M1 SEGMENT. THE PIPELINE DEPLOYED AND OPENED BEAUTIFULLY. THE PHYSICIAN DECIDED TO GO UP WITH A SCEPTER 4 X 10 BALLOON (MICROVENTION) TO DILATE THE PIPELINE SEVERAL TIMES EVEN THOUGH THERE WAS NO EVIDENCE OF THE PIPELINE NOT OPENING ALL THE WAY. AS THE PHYSICIAN DILATED THE PIPELINE SEVERAL TIMES WITH THE BALLOON, THE M2 VESSEL RUPTURED. THE PATIENT WAS ON ANTICOAGULANTS AND THERE WAS NO WAY TO STOP THE BLEEDING AND SUBSEQUENTLY, THE PATIENT EXPIRED. THE DEATH WAS RULED AS PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434088 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77250-16 9662573

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death| R| S