BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER MUSCULAR VSD OCCLUDER

    MDR report key: 2883569 · Received December 21, 2012

    Report

    Report Number
    2135147-2012-00192
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER MUSCULAR VSD 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 LOADER WITHOUT ANY DEFORMITIES. USING A TEST 7F AMPLATZER TORQVUE DELIVERY SYSTEM, THE DEVICE WAS LOADED, HANDED-OFF TO THE SHEATH, ADVANCED, DEPLOYED, AND RECAPTURED WITHOUT ISSUE. 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.

    Description of Event or Problem · 1

    THE 12MM AMPLATZER MUSCULAR VSD OCCLUDER (MUSCVSD) COULD NOT BE RECAPTURED INTO THE 8F AMPLATZER TORQVUE 180 DELIVERY SYSTEM (LOT NUMBER 1202017120) DURING THE PROCEDURE. THE PATIENT WAS SENT TO SURGERY FOR REMOVAL OF THE MUSCVSD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER MUSCULAR VSD OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-VSD-MUSC-012 1207318055

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention