BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1982649 · Received February 9, 2011

    Report

    Report Number
    2135147-2011-00006
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 9, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 18MM AMPLATZER SEPTAL OCCLUDER (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 USING A TEST DELIVERY SYSTEM, THE DEVICE WAS RETRACTED INTO THE LOADER AND UPON DEPLOYMENT, THE DEVICE DEPLOYED WITHOUT ANY DEFORMITIES.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. THE RESULTS OF THE DEVICE INVESTIGATION CONFIRMED THE 18MM ASO MET MANUFACTURING SPECIFICATIONS UPON RETURN TO AGA MEDICAL AND PRIOR TO SHIPMENT. THE CAUSE OF THE PATIENT'S EMBOLIZATION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, A 16MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS ATTEMPTED BUT WAS DETERMINED TO BE TOO SMALL AND REMOVED. THE DEFECT WAS SIZED WITH A SIZING BALLOON TO STOP-FLOW WITH MEASUREMENTS OF 14 X 18MM. AN 18MM ASO WAS THEN DEPLOYED AND RELEASED. THE ASO EMBOLIZED TO THE LEFT ATRIUM AND THEN TO THE LEFT VENTRICLE. THE ASO WAS SURGICALLY REMOVED IN THE OPERATING ROOM AND THE DEFECT WAS SURGICALLY CLOSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING IMAGING OF THE IMPLANT PROCEDURE, BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-018 1005112607

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention