BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1930094 · Received December 16, 2010

    Report

    Report Number
    2135147-2010-00174
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 24MM ASO WAS RETURNED TO AGA MEDICAL IN ITS ORIGINAL CONFIGURATION. FOLLOWING DECONTAMINATION, THE DEVICE WAS MEASURED AND THE SIZE WAS CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICE WAS EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED. USING A TEST DELIVERY SYSTEM, THE DEVICE WAS RETRACTED INTO THE LOADER AND UPON DEPLOYMENT, THE DEVICE DEPLOYED WITHOUT ANY DEFORMITIES. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT AND VERIFICATION OF DEVICE SIZING. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. OUR INVESTIGATION WAS ABLE TO CONFIRM THE 24MM ASO MET SPECIFICATION UPON RETURN TO AGA MEDICAL AND PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, INTRACARDIAC ECHOCARDIOGRAM (ICE) SHOWED AN ISOLATED SECUNDUM ATRIAL SEPTAL DEFECT 20 X 25MM IN DIAMETER WITH A TOTAL SEPTAL LENGTH OF 35 X 40MM. THE STOP FLOW STRETCHED DIAMETER BY ECHOCARDIOGRAM WAS 25 X 27MM. STOP FLOW STRETCHED DIAMETER BY CINE WAS 23 X 25MM. THERE WAS DEFICIENCY OF THE IVC RIM. INITIALLY A 24MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS USED WITH TWO COMPLETE RECAPTURES BEFORE STABLE DEPLOYMENT. AFTER THE ASO WAS RELEASED THE LEFT ATRIAL DISC WAS SEEN TO HAVE PROLAPSED ALONG THE DEFICIENT IVC RIM. THERE WAS APPROXIMATELY A 3-4MM RESIDUAL SHUNT. THE ASO WAS THUS REMOVED USING A 10MM SNARE DRAWN THOUGH A 10F HAUSDORF SHEATH WITHOUT DIFFICULTY. A 28MM ASO WAS THEN DELIVERED THROUGH THE HAUSDORF SHEATH WITH A TOTAL OF SEVEN COMPLETE RECAPTURES BEFORE APPROPRIATED AND STABLE DEPLOYMENT COULD BE ACHIEVED. ICE AND TTE SHOWED APPROPRIATE DEVICE CONFIGURATION WITH A SMALL RESIDUAL SHUNT THROUGH THE CENTER OF THE DEVICE.

    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 1009036668

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention