BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 1890309 · Received November 3, 2010

    Report

    Report Number
    2135147-2010-00156
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 3, 2010
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) WAS RECEIVED AT AGA MEDICAL IN ITS ORIGINAL CONFIGURATION. THE DEVICE WAS DECONTAMINATED, MEASURED, AND CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICE WAS EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED. USING A TEST DELIVERY SYSTEM, THE DEVICE WAS RETRACTED INTO THE LOADER AND UPON DEPLOYMENT, THE DEVICE DEFORMED INTO A COBRA SHAPE.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. OUR INVESTIGATION WAS ABLE TO REPRODUCE THE PERFORMANCE DESCRIBED. WE CONTINUE TO WORK WITH MANUFACTURING AND RESEARCH AND DEVELOPMENT TO UNDERSTAND THE FACTORS INVOLVED IN DEVICE DEFORMATION. ADDITIONALLY, THE AMPLATZER SEPTAL OCCLUDER INSTRUCTIONS FOR USE STATES THE FOLLOWING IN THE WARNINGS SECTION: DO NOT RELEASE THE DEVICE 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.

    Description of Event or Problem · 1

    ACCORDING TO INITIAL INFORMATION RECEIVED, A 32MM AMPLATZER SEPTAL OCCLUDER'S (ASO) RIGHT ATRIAL DISC DEFORMED INTO A COBRA SHAPE UPON DEPLOYMENT. THIS WAS DOCUMENTED ON AN ANGIOGRAM SHOWING THE DEFORMED DEVICE DEFORMED WHILE IT REMAINED CONNECTED TO THE DELIVERY CABLE. FOR REASONS THAT COULD NOT BE DELINEATED, THE PHYSICIAN ENCOUNTERED DIFFICULTY RETRACTING THE ASO INTO THE SHEATH, SO THE ASO WAS RELEASED FROM THE DELIVERY CABLE OF THE 12F AMPLATZER TORQVUE DELIVERY SYSTEM (B)(4). THE ASO WAS SURGICALLY REMOVED. PLEASE REFERENCE MDR 2135147-2010-00159 FOR THE ASSOCIATED (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-032 1005112626

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention