BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2973525 · Received February 22, 2013

    Report

    Report Number
    2135147-2013-00011
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING MANUFACTURING, THE 18MM AND 22MM ASOS UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THE DEVICES SUCCESSFULLY COMPLETED THESE TESTS. 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. 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

    THE PATIENT'S SECUNDUM ATRIAL SEPTAL DEFECT MEASURED 21.8MM BY TRANSTHORACIC ECHO AND EXHIBITED AORTIC RIM DEFICIENCY. ALSO, THE POSTERIOR RIM MEASURED 8.6MM; THE INFERIOR-POSTERIOR RIM WAS FLOPPY AND MEASURED 16.8MM; STOP-FLOW DIAMETER MEASURED 17.9MM; AND THE PATIENT'S QP/QS RATIO WAS 2.2. AN 18MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS ATTEMPTED BUT AS IT WAS BEING DEPLOYED, THE CONNECTING WAIST TORE THE FLOPPY RIM SO THE 18MM ASO WAS REMOVED. A 22MM ASO WAS ATTEMPTED BUT WAS DEEMED TOO SMALL AND REMOVED. BALLOON-SIZING WAS REPEATED AND SHOWED A NEW MEASUREMENT OF 27.3MM AND A 28MM ASO WAS SUCCESSFULLY IMPLANTED. APPROXIMATELY THREE MONTHS LATER AT A ROUTINE FOLLOW-UP, A TRANSESOPHAGEAL ECHO REVEALED A FISTULA BETWEEN THE ASCENDING AORTA AND THE RIGHT ATRIUM AND A QP/QS RATIO OF 1.2. THE PATIENT WAS ASYMPTOMATIC. THREE DAYS LATER, THE ASO WAS EXPLANTED AND THE FISTULA WAS SURGICALLY REPAIRED.

    Description of Event or Problem · 1

    A 28MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SUCCESSFULLY IMPLANTED. APPROXIMATELY THREE MONTHS LATER, A LEFT-TO-RIGHT AORTIC SHUNT WAS FOUND AS VERIFIED BY ANGIOGRAPHY AND TRANS-ESOPHAGEAL ECHOCARDIOGRAPHY, AND EROSION WAS SUSPECTED. THE PATIENT HAS NOT REPORTED ANY CHEST DISCOMFORT; HOWEVER, THE ASO WAS EXPLANTED (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78267 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-028 0911166872

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention