BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 3161635 · Received June 11, 2013

    Report

    Report Number
    2135147-2013-00046
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 22MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS RECEIVED AT SJM AND DECONTAMINATED. THE ASO WAS GROSSLY AND MICROSCOPICALLY EXAMINED AND NO ANOMALIES WERE FOUND. THE ASO MET DIMENSIONAL SPECIFICATIONS WHEN MEASURED WITH A CALIBRATED CALIPER. THE ASO WAS LOADED INTO A TEST 10F LOADER AND DEPLOYED AND RETRACTED WITHOUT DIFFICULTY OR DEFORMATION. 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, PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    A COMPLICATED MULTI-FENESTRATED ATRIAL SEPTAL DEFECT WAS BALLOON-SIZED WITH ECHO AND FLUOROSCOPY AND A 22MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS CHOSEN. THE ASO WAS IMPLANTED SUCCESSFULLY. WHILE TRYING TO CROSS ANOTHER DEFECT THE 22MM ASO DISLODGED AND ULTIMATELY ENDED UP IN THE LEFT VENTRICLE OUTFLOW TRACT. THE ASO WAS SUCCESSFULLY SNARED AND THE CASE RESUMED. AFTER RESIZING, A 26MM ASO WAS IMPLANTED. THE SECOND DEFECT WAS SIZED AND A 16MM ASO WAS CHOSEN. UPON DELIVERING THE LEFT ATRIAL DISC IT ASSUMED A COBRA FORMATION. THE ASO WAS TAKEN OUT AND INSPECTED. THE ASO RESUMED ITS NORMAL SHAPE SO IT WAS PREPPED AND LOADED. ONCE AGAIN UPON DEPLOYMENT OF THE LEFT ATRIAL DISC IT ASSUMED A COBRA SHAPE. AT THIS TIME, THE DEVICE WAS REMOVED AND ANOTHER 16MM ASO WAS USED AND DEPLOYED SUCCESSFULLY. THE PATIENT TOLERATED THE CASE WELL WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262765 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-022 1103244998

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention