BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 1912698 · Received November 24, 2010

    Report

    Report Number
    2017233-2010-00521
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 23, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE DEVICE MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 25MM GORE HELEX SEPTAL OCCLUDER ON (B)(6)2010, TO CLOSE AN ATRIAL SEPTAL DEFECT. DURING THE CARDIAC CATHETERIZATION PROCEDURE, THE PT DEVELOPED COMPLETE HEART BLOCK. THE FOLLOWING DAY, THE HEART BLOCK PERSISTED AND A STEROID INFUSION WAS ADMINISTERED. ON (B)(6) 2010, ECHOCARDIOGRAPHY SHOWED A 2-3MM PERICARDIAL EFFUSION AND THE ARRHYTHMIA PERSISTED. ON (B)(6) 2010, THE EFFUSION HAD REDUCED IN SIZE. THE PT WAS ISSUED A HOLTER MONITOR, PRESCRIBED ORAL STEROIDS, AND DISCHARGED FROM THE HOSPITAL. FOLLOWING DISCHARGE, HOLTER MONITOR READINGS SHOW IMPROVED CONDUCTION WITH PERIODS OF SINUS RHYTHM AND SECOND DEGREE HEART BLOCK. THE PT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HELEX SEPTAL OCCLUDER MLV/OCCLUDER, TRANSCATHETER SEPTAL MLV W.L. GORE & ASSOCIATES WLG216 8383446

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention