BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2113012 · Received June 3, 2011

    Report

    Report Number
    2029214-2011-00127
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT.MODEL# AND LOT# OF THE OTHER PIPELINE WAS USED:MODEL# LOT# DOM EXPFA-77350-10 JU10-043 07/01/2010 07/01/2013(B)(4)

    Description of Event or Problem · 1

    EMBOLIZATION TREATMENT OF AN ICA ANEURYSM PREVIOUSLY COILED. IT WAS REPORTED TWO PIPELINES WERE DEPLOYED AND ONE WAS POSSIBLY PROLAPSED AND THE OTHER WITH SOME CONSTRICTION. BALLOON ANGIOPLASTY WAS PERFORMED AND BOTH PIPELINES COMPLETELY OPENED. END OF PROCEDURE, RIGHT A1 IS NOTED VERY SLOW COLLATERAL FILLING. PREVIOUS RUN WAS REVIEWED AND SHOW RIGHT A1 IS OCCLUDED WITH SIMULTANEOUS BLOOD PRESSURE INCREASED AS EVIDENT. THE PATIENT WAS ADMINISTERED WITH HEPARIN AND AWOKE WITH LEFT SIDE PARALYSIS. AFTERWARD, CT SCAN WAS PERFORMED AND SHOWED THAT THERE WAS A SMALL FRONTAL INFARCT AND AREAS OF ISCHEMIA. IT WAS REPORTED THE PATIENT HAS A MILD WEAKNESS LEFT SIDE AND HAS RECOVERED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE EMBOLIZATION DEVICE HCG EV3 NEUROVASCULAR FA-77325-16 9434138

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention| S