BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2213960 · Received August 17, 2011

    Report

    Report Number
    2135147-2011-00109
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 21, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AGAS MEDICAL CONSULTANT THE FOLLOWING CONCLUSION WAS DRAWN: THE IMAGES PROVIDED WERE STILL IMAGES OF FLUOROSCOPY SHOWING BALLOON SIZING OF THE ASD FOLLOWED BY A LEFT UPPER PULMONARY VEIN TECHNIQUE FOR DEPLOYMENT OF THE ASO. THE DEVICE IN THE LAST STILL IMAGE DID NOT APPEAR STABLE. BASED ON THE LIMITED INFORMATION PROVIDED FOR REVIEW, THE CASE CANNOT BE OBJECTIVELY REVIEWED. ECHOCARDIOGRAPHIC IMAGES ARE CRUCIAL TO DETERMINE THE CAUSE OF DEVICE EMBOLIZATION. THE CAUSE OF THE EMBOLIZATION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: SUCH AS IMAGES AND RECORDS WERE REQUESTED. WHEN OUR INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS.

    Description of Event or Problem · 1

    ACCORDING TO NEW INFORMATION RECEIVED, THE DEFECT MEASURED ALMOST 36MM (BALLOON-SIZING, STRETCHED) AND THE AORTIC RIM WAS DEFICIENT. ONE TO TWO HOURS POST-IMPLANT, AN ECHOCARDIOGRAM REVEALED THE ASO HAD EMBOLIZED. NO ATTEMPT WAS MADE TO RETRIEVE THE DEVICE PERCUTANEOUSLY.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, A 36MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS BEING ATTEMPTED BUT DID NOT SEAT CORRECTLY IN THE DEFECT DUE TO INSUFFICIENT RIMS SO IT WAS REMOVED. A 38MM ASO WAS ATTEMPTED AND APPEARED TO BE CORRECTLY POSITIONED AND WAS RELEASED. THE NEXT MORNING, THE 38MM HAD EMBOLIZED AND THE PATIENT WAS REFERRED TO SURGERY TO HAVE THE ASO SURGICALLY REMOVED.

    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 1102032997

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention