BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 1896994 · Received November 11, 2010

    Report

    Report Number
    2135147-2010-00164
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    November 4, 2010
    Report Date
    February 4, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 7F AMPLATZER TORQVUE LOADER WITHOUT ANY DEFORMITIES. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS, INCLUDING VERIFICATION OF DEVICE SIZING. REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY PASSED THESE INSPECTIONS. THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE AND THE CAUSE OF THE EMBOLIZATION REMAINS UNKNOWN. PLEASE LET US KNOW IF THERE IS FURTHER INFORMATION THAT WILL HELP US TO UNDERSTAND THIS EVENT.

    Additional Manufacturer Narrative · 1

    AGA REQUESTED FURTHER INFORMATION REGARDING THIS CASE BUT MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED. THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE NO ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE PATIENTS EMBOLIZATION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    PROCEDURAL IMAGES RECEIVED INCLUDED FLUOROSCOPIC AND ECHOCARDIOGRAPHIC IMAGES. THE FLUOROSCOPIC IMAGES INCLUDED BALLOON-SIZING. CINE-FLUOROSCOPIC IMAGES ILLUSTRATED DEVICE DEPLOYMENT. ECHOCARDIOGRAPHIC IMAGES INCLUDED 15 STILL IMAGES OF THE ASD IN MULTIPLE TEE VIEWS. ECHO IMAGES 16 THROUGH 58 COULD NOT BE OPENED, THEREFORE, COULD NOT BE ANALYZED. THE CAUSE OF THE EMBOLIZATION COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THIS 15MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS BEING IMPLANTED TO REPAIR THE PATIENT'S SECUNDUM SEPTAL DEFECT; HOWEVER, THE ASO EMBOLIZED SOON AFTER IT WAS DEPLOYED. THE ASO WAS SUCCESSFULLY RETRIEVED DURING THE 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-015 0908213999

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Required Intervention