BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2212326 · Received August 15, 2011

    Report

    Report Number
    2135147-2011-00107
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 20, 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

    DEVICE ANALYSIS: THE 16MM 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 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. IMAGE ANALYSIS: 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. CONCLUSION: THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED. THE CAUSE OF THE EMBOLIZATION REMAINS UNKNOWN.

    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 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. ALSO, ADDITIONAL INFORMATION SUCH AS IMAGES AND RECORDS WERE REQUESTED; WHEN OUR INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE (B)(6) YEAR-OLD PATIENT'S ATRIAL SEPTAL DEFECT WAS SIZED USING A SIZING BALLOON (14-15MM) AND AN ECHOCARDIOGRAM (13-15MM). ON JULY 12, A 14MM ASO WAS ATTEMPTED BUT WAS FOUND TO BE TOO SMALL SO THE ASO WAS UPSIZED AND A 16MM ASO WAS IMPLANTED. WITHIN 24 HOURS, THE 16MM ASO EMBOLIZED AND WAS SNARED USING A 25MM SNARE CATHETER. THE PATIENT'S ANATOMY COULD NOT TOLERATE A LARGER DEVICE SO THE PATIENT WAS REFERRED TO SURGERY FOR SURGICAL CLOSURE OF THE DEFECT. NO ADVERSE PATIENT EFFECTS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-016 1004131521

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention