BEUDAMED
    FDA Adverse Event Summary report: N

    HELEX

    MDR report key: 1010521 · Received February 8, 2008

    Report

    Report Number
    1010521
    Date Received
    February 8, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 8, 2008
    Manufacturer
    W.L. GORE AND ASSOCIATES, IN.
    Product Code
    MLV
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN IMPLANTATION OF A GORE HELEX SEPTAL OCCLUDER DEVICE TO CLOSE A PATENT FORAMEN OVALE. SEVERAL DAYS LATER, THE PATIENT DEVELOPED AN EXERTIONAL DYSPNEA AFTER LIFTING HER CHILD FROM A STROLLER. EVALUATION IN THE CARDIAC SERVICES CLINIC AND IN RADIOLOGY REVEALED EMBOLIZATION OF THE DEVICE FROM THE ATRIAL SEPTUM TO THE ABDOMINAL AORTA. THE PATIENT HAD THE DEVICE SUCCESSFULLY REMOVED FROM THE AORTA SEVEN DAYS AFTER THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELEX SEPTAL OCCLUDER MLV W.L. GORE AND ASSOCIATES, IN. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR CARDIAC DRUGS| CARDIAC DRUGS