BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2831072 · Received November 14, 2012

    Report

    Report Number
    2135147-2012-00171
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 27, 2012
    Report Date
    October 27, 2012
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REVIEWED BY THE ST. JUDE MEDICAL EROSION BOARD AND CONFIRMED THAT EROSION OCCURRED.

    Additional Manufacturer Narrative · 1

    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. THE 17MM AMPLATZER SEPTAL OCCLUDER WAS RETURNED TO SJM 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.

    Description of Event or Problem · 1

    A 17MM AMPLATZER OCCLUDER (ASO) WAS USED TO CLOSE A LARGE SEPTAL DEFECT IN THIS PATIENT WITH MULTI-FENESTRATIONS THE PATIENT WAS OBSERVED FOR SEVENTY-TWO HOURS. THREE DAYS AFTER THE PROCEDURE, THE ASO LEFT ATRIAL DISK WAS PROTRUDING INTO THE POSTERIOR WALL OF THE AORTA. THE PATIENT WAS TAKEN IN FOR URGENT DEVICE REMOVAL AND PATCH CLOSURE. SURGICAL FINDINGS REVEALED THE ASO LYING WITHIN THE LEFT ATRIUM AS THE DEVICE HAD BECOME UNSEATED WHILE PLACING THE PATIENT ON BYPASS. THE DEVICE WAS REMOVED FROM THE SEPTAL DEFECT WITHOUT DIFFICULTY. AFTER DEFECT REPAIR, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A 2-4MM FISTULA FROM THE LEFT ATRIA INTO THE AORTA. THE PATIENT WAS PUT ON BY-PASS AND THE AORTIC WALL WAS 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-017 1205011709

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R