BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1993973 · Received February 16, 2011

    Report

    Report Number
    2135147-2011-00008
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 31, 2011
    Report Date
    March 21, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE 24MM ASO WAS RETURNED TO AGA MEDICAL IN ITS ORIGINAL CONFIGURATION. THE DISTAL DISC STITCHING WAS INADVERTENTLY DAMAGED DURING DECONTAMINATION. FOLLOWING DECONTAMINATION, THE ASO WAS MEASURED AND THE SIZE WAS CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE ASO WAS EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED. WITH THE EXCEPTION OF THE DAMAGE CAUSED DURING DECONTAMINATION. USING A TEST DELIVERY SYSTEM, THE DEVICE WAS RETRACTED INTO THE LOADER AND UPON DEPLOYMENT, THE DEVICE DEPLOYED WITHOUT ANY DEFORMITIES.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. IMAGING REVIEW: 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. CONCLUSION: THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED AND THE ASO MET SPECIFICATIONS PRIOR TO SHIPMENT AND UPON ANALYSIS AT AGA MEDICAL. THE CAUSE OF THE EMBOLIZATION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, A 24MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SUCCESSFULLY IMPLANTED IN THIS (B)(6), FEMALE PATIENT. THE DEFECT HAD BEEN SIZED VIA INTRACARDIAC ECHOCARDIOGRAM AND MEASURED 20, 22 AND 21MM FOLLOWING THREE MEASUREMENTS. A 2D-ECHO CONFIRMED GOOD PLACEMENT AND FUNCTION OF THE DEVICE AND THE PATIENT WAS DISCHARGED TO HOME THE SAME DAY. ONE MONTH LATER, A FOLLOW-UP ECHO SHOWED THE ASO HAD EMBOLIZED INTO THE LEFT MAIN PULMONARY ARTERY. THE ASO WAS PERCUTANEOUSLY SNARED. THE PATIENT WAS SCHEDULED FOR SURGICAL CLOSURE OF THE DEFECT. MEDICAL RECORDS AND IMAGES HAVE BEEN REQUESTED AND THE DEVICE WAS RECENTLY RETURNED FOR ANALYSIS. WHEN MORE INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 1006013445

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Congenital Anomaly| R