BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER MUSCULAR VSD OCCLUDER

    MDR report key: 2212314 · Received August 15, 2011

    Report

    Report Number
    2135147-2011-00106
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 15, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER MUSCULAR VSD OCCLUDER WAS RETURNED TO AGA MEDICAL 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. USING A TEST 8F AMPLATZER TORQVUE DELIVERY SYSTEM, THE DEVICE WAS LOADED, HANDED-OFF TO THE SHEATH, ADVANCED, DEPLOYED, AND RECAPTURED WITHOUT ISSUE. THE DELIVERY SYSTEM USED IN THE EVENT WAS NOT RETURNED AND COULD NOT BE ANALYZED. 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 UNABLE TO REPRODUCE OR CONFIRM THE PERFORMANCE DESCRIBED. A SMALL PERCENTAGE OF OCCLUDERS MAY DEFORM WHEN DEPLOYED FROM THE DELIVERY SYSTEM, DUE IN PART TO THE INHERENT MATERIAL PROPERTIES OF NITINOL. AGA MEDICAL HAS PUT A NUMBER OF CORRECTIVE ACTIONS IN PLACE THAT HAVE SUCCESSFULLY REDUCED THE RATE OF OCCURRENCE OF THIS POTENTIAL DEFORMATION AND ALL COMPLAINT RATES ARE REVIEWED QUARTERLY BY SENIOR MANAGEMENT.  CURRENTLY THE RATE OF OCCURRENCE OF THIS POTENTIAL OBSERVATION IS BELOW THE RATE ANTICIPATED IN OUR RISK DOCUMENTS.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, A 16MM AMPLATZER MUSCULAR VSD (MUSCVSD) DEFORMED INTO A MUSHROOM SHAPE UPON DEPLOYMENT. DUE TO THE DEFORMATION, THE DEVICE WAS DIFFICULT TO RETRACT FROM THE EXISTING 8F AMPLATZER TORQVUE DELIVERY SYSTEM (DTV) SHEATH. A 12F SHORT INTRODUCER SHEATH WAS CUT ALONGSIDE AND PUT OVER THE 8F DTV WHICH ENABLED THE WITHDRAWAL OF THE MUSCVSD AND 8F DTV FROM THE PATIENT. AN 18MM MUSCVSD WAS IMPLANTED SUCCESSFULLY.

    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-016 1006224252

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention