BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2527844 · Received April 11, 2012

    Report

    Report Number
    2135147-2012-00065
    Event Type
    Other
    Date Received
    April 11, 2012
    Date of Event
    December 1, 2007
    Report Date
    April 10, 2012
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS IS NOT A REPORTABLE EVENT, AGA MEDICAL IS SUBMITTING THIS REPORT SINCE A VOLUNTARY REPORT (B)(4) WAS SUBMITTED BY THE HOSPITAL. THE 10MM AMPLATZER SEPTAL OCCLUDER WAS RECEIVED AT AGA MEDICAL IN A COBRA SHAPE AND DECONTAMINATED. THE DEVICE WAS RECONFIGURED INTO ITS ORIGINAL SHAPE, MEASURED, AND CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICE WAS EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED. THE DEVICE WAS LOADED AND DEPLOYED FROM A TEST 6F LOADER INTO A COBRA SHAPE. 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. ACCORDING TO THE AMPLATZER SEPTAL OCCLUDER INSTRUCTIONS FOR USE, THE WARNINGS SECTION LISTS THE FOLLOWING STATEMENT: DO NOT RELEASE THE AMPLATZER SEPTAL OCCLUDER FROM THE DELIVERY CABLE IF THE DEVICE DOES NOT CONFORM TO ITS ORIGINAL CONFIGURATION OR IF THE DEVICE POSITION IS UNSTABLE. RECAPTURE THE DEVICE AND REDEPLOY. IF STILL UNSATISFACTORY, RECAPTURE THE DEVICE AND REPLACE WITH A NEW DEVICE. OUR INVESTIGATION WAS ABLE TO REPRODUCE AND CONFIRM THE PERFORMANCE DESCRIBED. WE HAVE LOGGED THIS EVENT IN OUR COMPLAINT HANDLING SYSTEM, AND WILL CONTINUE TO MONITOR OVERALL PRODUCT PERFORMANCE TO IDENTIFY ANY PATTERNS IN FIELD EVENTS.

    Description of Event or Problem · 1

    TO SUMMARIZE THIS EVENT, THE 10MM AMPLATZER SEPTAL OCCLUDER (ASO) DEFORMED DURING DEPLOYMENT IN AN ATRIAL SEPTAL DEFECT. THE DEVICE HAD BEEN DEPLOYED AND RETRACTED INTO THE DELIVERY SYSTEM (SHEATH AND/OR LOADER) TWICE. NEITHER THE DEVICE AND/OR DELIVERY CABLE WAS INADVERTENTLY ROTATED IN THE LOADER AND/OR SHEATH. NO ADDITIONAL PRESSURE OR FORCE WAS NECESSARY TO ADVANCE THE DEVICE THROUGH THE SHEATH. A 7F AMPLATZER 45 DELIVERY SYSTEM WAS UTILIZED. ANOTHER ASO WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-010 M07D24-44

    Patients

    Seq Age Sex Outcome Treatment
    1