BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2862734 · Received December 10, 2012

    Report

    Report Number
    2135147-2012-00181
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER SEPTAL OCCLUDER WAS RETURNED TO SJM 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 SIZE AND FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS.

    Description of Event or Problem · 1

    THE 24MM AMPLATZER SEPTAL OCCLUDER RUBBED AGAINST THE AORTIC RIM WITH LEFT ATRIAL DISC SPLAYING SO THIS ASO WAS REMOVED. A 20MM ASO WAS IMPLANTED BUT EMBOLIZED UPON RELEASE AND WAS PERCUTANEOUSLY RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-020 1111023460

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention