BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1953529 · Received January 10, 2011

    Report

    Report Number
    2135147-2011-00001
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    January 10, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE DEVICE WAS LOADED AND DEPLOYED FROM A TEST 9F LOADER 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. AGA REQUESTED FURTHER INFORMATION REGARDING THIS CASE, BUT MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED. ECHOCARDIOGRAMS ARE NEEDED TO CONFIRM SIZING AND EVALUATE OTHER PARAMETERS OF THE IMPLANT PROCEDURE. OUR INVESTIGATION WAS ABLE TO CONFIRM THE 24MM ASO MET MANUFACTURING SPECIFICATIONS UPON RETURN TO AGA MEDICAL AND PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, A 24MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS DEPLOYED IN A DEFECT MEASURING 18X23MM DURING A ROUTINE PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE ICU FOLLOWING THE PROCEDURE, BUT AN ARRHYTHMIA DEVELOPED. THE ASO WAS THEN CONFIRMED TO HAVE EMBOLIZED TO THE RIGHT VENTRICLE. AN ATTEMPT TO PERCUTANEOUSLY RETRIEVE THE ASO WITH A SNARE CATHETER WAS UNSUCCESSFUL AS THE MICRO SCREW END WAS FACING AWAY. THE PATIENT WAS TRANSFERRED TO SURGERY WHERE THE DEFECT WAS SURGICALLY CLOSED. THE PATIENT WAS NOTED TO BE IN GOOD HEALTH AND WAS DISCHARGED FIVE DAYS AFTER THE EVENT.

    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 0906292150

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention