BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 1915178 · Received December 6, 2010

    Report

    Report Number
    2135147-2010-00176
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    October 15, 2010
    Report Date
    December 6, 2010
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER SEPTAL 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 12F 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 AND VERIFICATION OF DEVICE SIZING. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED, THEREFORE, THE CAUSE OF THE EMBOLIZATION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE PATIENT IMPLANTED WITH THIS 38MM AMPLATZER SEPTAL OCCLUDER (ASO) HAD INSUFFICIENT POSTERIOR (2MM) AND SUPERIOR (4 MM) RIMS. APPROXIMATELY 24 HOURS POST-PROCEDURE, THE ASO EMBOLIZED. THE DEVICE WAS SURGICALLY RETRIEVED AND THE PATIENT'S DEFECT WAS SURGICALLY CLOSED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-038 M09C20-23

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention