BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 3980050 · Received August 5, 2014

    Report

    Report Number
    2135147-2014-00076
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SJM COULD NOT EVALUATE THE ADO INVOLVED IN THIS INCIDENT SINCE IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD FOR THIS PRODUCT WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. THE CAUSE FOR THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    A 5/4MM AMPLATZER DUCT OCCLUDER (ADO) WAS PLACED IN THE AMPULLA OF THE DUCT INSTEAD OF THE DUCT ITSELF. AS A RESULT, IT MOVED AND WAS SITTING PARTLY IN THE AORTA. THE ADO WAS SNARED AND PULLED BACK INTO THE AMPULLA. THE ADO REMAINS IMPLANTED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457741 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA-003 3929830

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention SNARE