BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2231796 · Received September 1, 2011

    Report

    Report Number
    2135147-2011-00121
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGA MEDICAL COULD NOT EVALUATE THE PRODUCT INVOLVED IN THIS EVENT SINCE IT WAS NOT RETURNED TO US. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. ALSO, ADDITIONAL INFORMATION - INCLUDING IMAGES AND RECORDS - WAS REQUESTED. WHEN FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: 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. CONCLUSION: THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED. THE CAUSE OF THE EMBOLIZATION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE PATIENT'S ATRIAL SEPTAL DEFECT (ASD) WAS SIZED USING A SIZING BALLOON AND WAS IMPLANTED WITH A 20MM AMPLATZER SEPTAL OCCLUDER (ASO). POST-IMPLANT, THE PATIENT WAS OBSERVED TO BE EXPERIENCING ECTOPIC HEARTBEATS AND A PRE-DISCHARGE TRANS-THORACIC ECHOCARDIOGRAM REVEALED THE ASO HAD EMBOLIZED INTO THE PULMONARY ARTERY. THE PATIENT WAS REFERRED BACK TO THE CATH LAB TO HAVE THE DEVICE PERCUTANEOUSLY RETRIEVED. DUE TO THE PATIENT'S ANATOMY, THE PATIENT WILL BE SCHEDULED FOR SURGERY TO HAVE THE ASD SURGICALLY REPAIRED IN LIEU OF A LARGER DEVICE. THE ASO WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-020 1005243145

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention