BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1894866 · Received November 10, 2010

    Report

    Report Number
    2135147-2010-00167
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    November 5, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 26MM ASO WAS RETURNED TO AGA MEDICAL 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. USING A TEST DELIVERY SYSTEM, THE DEVICE WAS RETRACTED INTO THE LOADER AND UPON DEPLOYMENT, THE DEVICE DEPLOYED WITHOUT ANY DEFORMITIES. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT AND VERIFICATION OF DEVICE SIZING. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. AGA REQUESTED FURTHER INFORMATION REGARDING THIS CASE, BUT MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED. ECHOCARDIOGRAMS ARE NEEDED TO CONFIRM SIZING AND EVALUATE OTHER PARAMETERS OF THE IMPLANT PROCEDURE. THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED. THE CAUSE OF THE PATIENT'S EMBOLIZATION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT FELT PAIN AND UNCOMFORTABLENESS.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE 26MM AMPLATZER SEPTAL OCCLUDER (ASO) EMBOLIZED AFTER THE IMPLANTATION WAS DONE. THE ASO WAS SURGICALLY REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING IMAGING OF THE IMPLANT PROCEDURE AND PATIENT INFORMATION, BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-026 0905180748

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention