BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 3173559 · Received June 17, 2013

    Report

    Report Number
    2135147-2013-00049
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 30, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 PRIOR TO SHIPMENT. THE CAUSE OF THE EMBOLIZATION IS UNKNOWN

    Description of Event or Problem · 1

    AN AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED ON (B)(6) 2013. DURING A FOLLOW UP VISIT ON (B)(6) 2013, IMAGING DOCUMENTED THE ASO HAD EMBOLIZED TO THE ABDOMINAL AORTA. THE OCCLUDER WAS PERCUTANEOUSLY REMOVED THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273671 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-014 1205011701

    Patients

    Seq Age Sex Outcome Treatment
    1 20 Required Intervention