BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 2180171 · Received July 27, 2011

    Report

    Report Number
    2135147-2011-00094
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    January 21, 2011
    Report Date
    September 9, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ACCORDING TO NEW INFORMATION WE RECEIVED, THE PATIENT'S PATENT DUCTUS ARTERIOSUS WAS SIZED WITH THE GUIDANCE OF AN X-RAY AND AN ECHOCARDIOGRAM. APPROXIMATELY 12 HOURS POST-IMPLANT, A FLUOROSCOPY REVEALED RESIDUAL SHUNTING. THE ADO WAS PERCUTANEOUSLY RETRIEVED AND ANOTHER 10/8MM ADO WAS SUCCESSFULLY IMPLANTED. ANALYSIS THE AMPLATZER DUCT OCCLUDER 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. THE DEVICE WAS LOADED AND DEPLOYED FROM A TEST 7F TORQVUE LOADER 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. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. CONCLUSION OUR INVESTIGATION WAS UNABLE TO CONFIRM THE PERFORMANCE DESCRIBED AT IMPLANT SINCE THE PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT AND DURING ANALYSIS. ALSO, WE RECOGNIZE THAT WE CANNOT FULLY REPRODUCE ALL OF THE VARIABLES ASSOCIATED WITH EVENTS, INCLUDING THE LABORATORY ENVIRONMENT OR CONTRIBUTING PATIENT FACTORS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED; IF FURTHER INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, A 10/8MM AMPLATZER DUCT OCCLUDER (ADO) WAS SUCCESSFULLY IMPLANTED; HOWEVER, RESIDUAL SHUNTING WAS OBSERVED 12 HOURS LATER SO THE ADO HAD TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA-006 M07K05-26

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention