BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 1201156 · Received October 20, 2008

    Report

    Report Number
    2135147-2008-00098
    Event Type
    Injury
    Date Received
    October 20, 2008
    Date of Event
    September 22, 2008
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER DUCT OCCLUDER WAS RECEIVED AT AGA MEDICAL IN ITS ORIGINAL CONFIGURATION. THE DEVICE WAS DECONTAMINATED, MEASURED, AND CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICE WAS EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED. THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE THE IMPLANT ECHOCARDIOGRAMS OR MEDICAL RECORDS WERE NOT PROVIDED TO AGA MEDICAL FOR REVIEW. ECHOCARDIOGRAMS ARE NEEDED TO CONFIRM SIZING, AND EVALUATE OTHER PARAMETERS OF THE IMPLANT PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AGA MEDICAL WILL FILE A SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    THE 6-4 AMPLATZER DUCT OCCLUDER (ADO) EMBOLIZED INTO THE AORTA, BY THE PIGTAIL CATHETER. THE PDA STRETCHED AND THE ADO RETENTION SKIRT DID NOT SIT IN THE AMPULLA AS INTENDED. AS A RESULT, THE ADO WAS SNARED AND ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY AGA MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA-004 M08C13-10

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Required Intervention