BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 2183348 · Received July 28, 2011

    Report

    Report Number
    2135147-2011-00090
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 28, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A PATIENT HAD A DIAGNOSIS OF A SECUNDUM ASD AND BALLOON SIZING WAS PERFORMED WITH A STRETCHED DIAMETER OF APPROX. 21MM, A SMALL AORTIC RIM AND A SEPTAL MISALIGNMENT. A 24MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS PLACED AND DEMONSTRATED GOOD CONFIGURATION; HOWEVER, AFTER RELEASE THE ASO CHANGED POSITION AND THE LEFT AND RIGHT DISCS MOVED TO THE RIGHT ATRIUM. THE ASO WAS SNARED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-024 1006013380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention