BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 1896991 · Received November 11, 2010

    Report

    Report Number
    2135147-2010-00161
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 11, 2010
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 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. AGA REQUESTED FURTHER INFORMATION REGARDING THIS CASE, BUT MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    PROCEDURAL IMAGES RECEIVED INCLUDED TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DURING DEPLOYMENT AND TRANSTHORACIC ECHOCARDIOGRAM (TTE) 1 DAY POST DEPLOYMENT. REVIEW OF THE IMAGES BY SJMS MEDICAL CONSULTANT INDICATED THAT THE ATRIAL SEPTUM WAS COMPLEX WITH AT LEAST THREE DEFECTS. THE PATIENTS SIZE MADE THE TTE IMAGES OF POOR ACOUSTICS AND QUALITY. THE PATIENT HAD A COMPLEX, ANEURISMAL, REDUNDANT ATRIAL SEPTUM WITH MULTIPLE DEFECTS INCLUDING TWO MODERATE-SIZED ATRIAL SEPTAL DEFECTS, A PFO AND ADDITIONAL DEFECTS. THE DEVICE IN THE LARGER DEFECT WAS UNDER-SIZED GIVEN THE ANATOMY OF THE DEFECT AND ITS PROXIMITY TO THE PFO. THIS CREATED MORE ROOM FOR THE SECOND DEFECT THAT WAS CLOSED WITH A SMALLER DEVICE. A 14MM DEVICE STAYED IN POSITION AS IT WAS A LITTLE LARGER AND HAD A CHANCE TO ORIENTATE ITSELF OVER THE FIRST DEVICE. AS THE CABLES WERE RELEASED, THE 14MM ASO ORIENTATED ITSELF TO THE SEPTUM BUT THE 12MM ASO, WHILE STILL ATTACHED TO THE CABLE, PIVOTED AND THEREFORE CAUSED TENSION ON THE REDUNDANT SEPTUM WHICH RESULTED IN NON-CAPTURE OF THE AV VALVE RIM CAUSING THE 12MM ASO TO EMBOLIZE POST-RELEASE. THE CAUSE OF THE EMBOLIZATION DID NOT APPEAR TO BE DEVICE RELATED BUT RATHER RELATED TO PATIENT ANATOMY AND DEVICE SELECTION.

    Description of Event or Problem · 1

    MULTIPLE DEFECTS WERE NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND SIMULTANEOUS BALLOON SIZING BY STOP FLOW. THE INFERIOR DEFECT WAS THOUGHT TO BE 14X12MM BY TEE WITH THE INFERIOR/SUPERIOR EDGE CLOSE TO THE SECUNDUM DEFECT. A 12MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED, BUT EMBOLIZED UPON RELEASE. THE ASO WAS RETRIEVED WITHOUT PROBLEMS FROM THE AORTA. A SECOND DEFECT WAS CLOSED WITH A 14MM ASO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-012 1006113868

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention