BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2181472 · Received July 27, 2011

    Report

    Report Number
    2135147-2011-00095
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 5, 2011
    Report Date
    September 29, 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

    IMAGE REVIEW: 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. ANALYSIS RESULTS: THE 24MM AND 11MM ASOS AND 25MM ACO WERE RETURNED TO AGA MEDICAL IN THEIR ORIGINAL CONFIGURATION. FOLLOWING DECONTAMINATION, THE DEVICES WERE MEASURED AND THE SIZE WAS CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICES WERE EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED. THE DEVICES WERE LOADED AND DEPLOYED FROM A TEST LOADER WITHOUT ANY DEFORMITIES. DURING MANUFACTURING, EACH DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER SIZE AND FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT AND VERIFICATION OF DEVICE SIZING. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED EACH DEVICE SUCCESSFULLY COMPLETED THESE TESTS. CONCLUSION: THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED RELATED TO THE 11MM ASO EMBOLIZATION, THEREFORE, THE CAUSE OF THE EMBOLIZATION REMAINS UNKNOWN. PLEASE LET US KNOW IF THERE IS FURTHER INFORMATION THAT WILL HELP US TO UNDERSTAND THIS EVENT. THE 24MM ASO AND 25MM ACO MET MANUFACTURING SPECIFICATIONS DURING ANALYSIS AT AGA MEDICAL AND PRIOR TO SHIPMENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INCLUDING IMAGES WAS REQUESTED. WHEN FURTHER INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO NEW INFORMATION RECEIVED, THE PATIENT'S DEFECTS WERE SIZED VIA TRANS-ESOPHAGEAL ECHOCARDIOGRAM, HOWEVER, MEASUREMENTS WERE NOT PROVIDED. THE PATIENT'S RIMS APPEARED SUFFICIENT. THE PATIENT WAS REFERRED FOR SURGERY TO HAVE ALL THE DEVICES SURGICALLY REMOVED. IT IS UNCONFIRMED WHETHER THE DEFECTS WERE SURGICALLY REPAIRED.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE PATIENT WAS UNDERGOING THE IMPLANT OF THREE AMPLATZER SEPTAL OCCLUDERS (ASO) -- A 24MM ASO, AN 11MM ASO, AND A 25MM CRIBRIFORM OCCLUDER (ACO) -- TO OCCLUDE MULTIPLE DEFECTS WHEN THE EVENT OCCURRED. FIRST, THE 24MM ASO WAS DETERMINED TO BE TOO LARGE AND IT WAS REMOVED. THE 11MM ASO AND 25MM ACO APPEARED TO BE SUCCESSFULLY IMPLANTED; HOWEVER, AS THE IMPLANT WAS NEARING COMPLETION, THE 11MM ASO EMBOLIZED WHEN THE GUIDING CATHETER TOUCHED AND DISLODGED THE DEVICE. THE PATIENT WAS REFERRED FOR SURGERY TO HAVE ALL THE DEVICES SURGICALLY REMOVED AND THE DEFECTS SURGICALLY REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-011 1103244951

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention