BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 1200867 · Received October 20, 2008

    Report

    Report Number
    2135147-2008-00097
    Event Type
    Injury
    Date Received
    October 20, 2008
    Date of Event
    August 27, 2007
    Report Date
    October 20, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE AMPLATZER DUCT OCCLUDER, THE DEVICE WAS RETURNED IN THE ORIGINAL CONFIGURATION, WAS MEASURED AND THE SIZE WAS CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICE WAS EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE EMBOLIZED INTO THE RIGHT PULMONARY ARTERY. THE PATIENT WAS SENT TO THE OR FOR THE RETRIEVAL OF THE DEVICE AND TO CLOSE THE PDA. THE DEFECT WAS SIZED BY ECHO AND THE MEASUREMENTS WERE 12 MM (PULMONARY SIDE) AND 16 MM (AORTA SIDE). AN ATTEMPT WAS MADE TO TRY TO RETRIEVE THE DEVICE PERCUTANEOUSLY, BUT IT WAS IMPOSSIBLE. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA-009 M06D24-68

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention