BEUDAMED
    FDA Adverse Event Summary report: N

    AMPLATZER MUSCULAR VSD OCCLUDER

    MDR report key: 2250866 · Received September 6, 2011

    Report

    Report Number
    2250866
    Date Received
    September 6, 2011
    Date of Event
    October 13, 2010
    Report Date
    November 11, 2010
    Manufacturer
    AGA MEDICAL CORP.
    Product Code
    MLV
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    A TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED. THE ATRIALCOMMUNICATION WAS VISUALIZED. IT APPEARED TO HAVE A THIN INFERIOR SEPTUM WITH POSSIBLE FENESTRATIONS. THE ATRIALSEPTAL DEFECT (ASD) ITSELF MEASURED APPROXIMATELY 12 MM IN DIAMETER. THE ATRIAL SEPTUM WAS APPROXIMATELY 32 MM IN DIAMETER. THEREAFTER, RIGHT AND LEFT HEART CATHETERIZATION THROUGH AN EXISTING ATRIAL COMMUNICATION WAS PERFORMED. BALLOON SIZING OF THE ATRIAL COMMUNICATION WAS PERFORMED. THE DEVICE WAS THEN CAREFULLY POSITIONED WITHIN THE ATRIAL SEPTUM USING TRANSESOPHAGEAL ECHOCARDIOGRAPHIC GUIDANCE. PUSH AND PULL MANEUVERS WERE PERFORMED. THE DEVICE APPEARED TO BE STABLE. THE DEVICE WAS THEN RELEASED AND WITHIN SECONDS, IT FELL INTO THE LEFT ATRIAL CHAMBER. THE SURGICAL TEAM WAS CONTACTED. IT WAS RECOMMENDED THAT THE PATIENT GO TO THE OPERATING ROOM FOR SURGICAL REMOVAL OF THE AMPLATZER DEVICE AND SIMULTANEOUS CLOSURE OF THE ATRIAL COMMUNICATION. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION.======================HEALTH PROFESSIONAL'S IMPRESSION======================UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER MUSCULAR VSD OCCLUDER AMPLATZER ASD OCCLUSION DEVICE MLV AGA MEDICAL CORP. * M09A02-15

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR NO OTHER THERAPIES