BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2973527 · Received February 22, 2013

    Report

    Report Number
    2135147-2013-00016
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 4, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    A 12MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED IN THE PATIENT'S VENTRICULAR SEPTAL DEFECT (VSD). SIMULTANEOUSLY, ANOTHER VSD WAS OBSERVED SO A 12MM AMPLATZER MUSCULAR VSD (MUSCVSD) WAS ATTEMPTED IN THE SECOND DEFECT BUT PULLED THROUGH THE DEFECT. THE MUSCVSD WAS REMOVED AND UPSIZED TO A 14MM ASO, HOWEVER, IT ALSO SLIPPED THROUGH THE DEFECT AND WAS REMOVED. THE PATIENT WAS REFERRED FOR SURGERY TO HAVE THE VENTRICULAR SEPTAL DEFECT REPAIRED WITH A PATCH. DURING THE SAME PROCEDURE, THE 12MM ASO WAS EXPLANTED AS ITS FORM WAS NOT APPROPRIATE FOR THE DEFECT SHAPE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78563 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-012 1202087396

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention