BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 3840305 · Received May 30, 2014

    Report

    Report Number
    2135147-2014-00054
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 26, 2014
    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 DEVICE HISTORY RECORD FOR THIS PRODUCT WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT'S ATRIAL SEPTAL DEFECT (ASD) WAS MEASURED AT 10MM WITH A SIZING BALLOON. A 12MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS TRIED BUT SLIPPED THROUGH THE ASD DUE TO THE SLIT-SHAPE ANATOMY. A 14MM ASO WAS SUCCESSFULLY IMPLANTED AFTER GOOD POSITION WAS CONFIRMED BY A PUSH-PULL TEST, FLUOROSCOPY, AND ECHO. THE NEXT DAY THE PATIENT FELT 'UNCOMFORTABLE' AND HER HEART FELT LIKE IT DID PRE-IMPLANTATION. A TRANSTHORACIC ECHO SHOWED THAT THE ASO HAD EMBOLIZED TO THE PULMONARY ARTERY (PA) CLOSE TO THE PULMONARY VALVE. A FLUORO FIFTEEN MINUTES LATER SHOWED THE ASO IN THE MAIN STEM OF THE PA. PERCUTANEOUS RETRIEVAL WAS NOT ATTEMPTED AND THE PATIENT WAS SENT TO ANOTHER HOSPITAL WHERE THE ASD WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318126 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-014 4178591

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention