BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 2941356 · Received February 4, 2013

    Report

    Report Number
    2135147-2013-00007
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 21, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED EVENT REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE ADO WAS RETURNED TO SJM 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. THE DEVICE WAS LOADED AND DEPLOYED FROM A TEST LOADER WITHOUT ANY DEFORMITIES. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    AFTER IMPLANTING AN 8/6MM AMPLATZER DUCT OCCLUDER (ADO) IN A VENTRICULAR SEPTAL DEFECT, THE RIGHT DISC DID NOT COMPLETELY OPEN AFTER IT WAS RELEASED, HOWEVER, THE ADO WAS LEFT IMPLANTED. APPROXIMATELY, 48 HOURS LATER, THE ADO HAD EMBOLIZED INTO THE AORTA. THE ADO WAS SNARED AND PERCUTANEOUSLY RETRIEVED WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46541 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA-005 1204241446

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention