BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1150965 · Received September 9, 2008

    Report

    Report Number
    2135147-2008-00072
    Event Type
    Injury
    Date Received
    September 9, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 9, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER® SEPTAL OCCLUDER AND AMPLATZER® DELIVERY SYSTEM CABLE WERE RECEIVED AT AGA MEDICAL IN THEIR ORIGINAL CONFIGURATION AND DECONTAMINATED. THE DEVICE WAS MEASURED AND THE SIZE WAS CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICE AND DELIVERY CABLE THREADS WERE EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED. THE DEVICE AND DELIVERY CABLE THREADS WERE EACH FOUND TO BE IN SPECIFICATION USING THREAD GAGES. THE DEVICE WAS ATTACHED FULLY AND SECURELY TO AND DETACHED FROM THE RETURNED DELIVERY CABLE USING MINIMAL EFFORT AND NO DIFFICULTIES WERE ENCOUNTERED. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT AND ATTACHING AND DETACHING TO A TEST DELIVERY CABLE. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. THE CAUSE OF THE EMBOLIZATION COULD NOT BE DETERMINED 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. HOWEVER, THE DEVICE AND DELIVERY CABLE WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AS EVIDENCED BY THE TESTING PERFORMED UPON RETURN TO AGA MEDICAL.

    Description of Event or Problem · 1

    TO SUMMARIZE THIS EVENT, UNDER FLUOROSCOPY AND TEE GUIDANCE AN ATRIAL SEPTAL DEFECT CLOSURE WAS PERFORMED. A 16MM AMPLATZER® SEPTAL OCCLUDER WAS SELECTED BUT WAS NOT UTILIZED DUE TO A FLOPPY RIM. AN 18MM AMPLATZER® SEPTAL OCCLUDER WAS THEN SELECTED. THE DEVICE WAS POSITIONED APPROPRIATELY AND STILL ATTACHED TO THE DELIVERY CABLE. MEANWHILE, THE PATIENT MOVED UNPREDICTABLY AND THE DEVICE DETACHED FROM THE DELIVERY CABLE AND EMBOLIZED TO THE RIGHT ATRIUM AND RIGHT VENTRICLE. PERCUTANEOUS RETRIEVAL WAS NOT ATTEMPTED. THE PATIENT WAS SENT TO SURGERY FOR REMOVAL OF THE DEVICE AND SURGICAL REPAIR OF THE ATRIAL SEPTAL DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING IMAGING OF THE IMPLANT PROCEDURE, 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 AMPLATZER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-018 M07J17-32

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention