BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2944539 · Received February 5, 2013

    Report

    Report Number
    2135147-2013-00009
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 23, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    A 24MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED. THE NEXT DAY, IT WAS FOUND TO HAVE EMBOLIZED. THE PATIENT WAS ADMITTED FOR SURGERY WHERE THE ASO WAS EXPLANTED AND THE ATRIAL SEPTAL DEFECT WAS SURGICALLY REPAIRED. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48137 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-024 1007305484

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention