BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2052223 · Received April 12, 2011

    Report

    Report Number
    2135147-2011-00029
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 12, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE PATIENT'S ATRIAL SEPTAL DEFECT (ASD) WAS CLOSED WITH A 24MM AMPLATZER SEPTAL OCCLUDER (ASO). A CHEST X-RAY FOUR HOURS POST IMPLANTATION SHOWED THE ASO HAD EMBOLIZED INTO THE DESCENDING AORTA. THE PATIENT RETURNED TO THE CATH LAB WHERE THE ASO WAS PERCUTANEOUSLY RETRIEVED AND REMOVED. THE ASD WAS THEN SUCCESSFULLY CLOSED WITH A 26MM ASO. THE PATIENT WAS DISCHARGED WITHOUT FURTHER SEQUELAE. IMAGING FOR THIS EVENT HAS BEEN RECEIVED AND IS CURRENTLY BEING REVIEWED. UPON COMPLETION OF THE REVIEW, OUR RESULTS WILL BE FORWARDED TO YOU IN A SUPPLEMENTAL REPORT.

    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 0911166869

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention