BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRACLUDE AORTIC OCCLUSION DEVICE

    MDR report key: 4103190 · Received September 19, 2014

    Report

    Report Number
    3008500478-2014-00120
    Event Type
    Death
    Date Received
    September 19, 2014
    Date of Event
    July 15, 2014
    Report Date
    August 22, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXC
    PMA / PMN Number
    K113182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETAINED BY THE HOSPITAL FOR EVALUATION. MANUFACTURING RECORDS WERE UNABLE TO BE REVIEWED DUE TO NO LOT NUMBER PROVIDED BY THE CUSTOMER. INADEQUATE CARDIOPLEGIA DELIVERY MAY OCCUR DURING AN MIVS CASE DUE TO SEVERAL REASONS, UNRECOGNIZED PRESENCE OF AORTIC INSUFFICIENCY, POOR BALLOON PLACEMENT, HIGH RESISTANCE TO FLOW IN CARDIOPLEGIA LINE, AND/OR EXCESSIVE MANIPULATION OF THE HEART DURING THE PROCEDURE. IF THE PATIENT RECEIVES INADEQUATE CARDIOPLEGIA DURING THE CASE, THIS MAY RESULT IN LOW CARDIAC OUTPUT SYNDROME (LCOS) DUE TO GLOBAL ISCHEMIA OF THE MYOCARDIUM. THIS MAY REQUIRE POSTOPERATIVE HEMODYNAMIC SUPPORT SUCH AS ECMO OR LVAD; THIS IS TYPICALLY PROCEDURE RELATED AND NOT DUE TO A DEVICE MALFUNCTION. NO DEVICE MALFUNCTION IS INDICATED IN THE REPORT AND THE EVENTS REPORTED ARE INCLUDED IN THE LABELING. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE USE OF THE EDWARDS QUALITY SYSTEMS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT INTRACLUDE AORTIC OCCLUSION DEVICE (INTRACLUDE) WAS USED DURING A MITRAL VALVE REPAIR CASE. IT WAS REPORTED THAT THE SURGICAL TEAM THOUGHT THAT BLOOD CARDIOPLEGIA WAS GOING TO SLOW, BUT COMMENTED IT WAS NOT RELATED TO AN ISSUE WITH THE INTRACLUDE. . IT WAS REPORTED THAT DURING THE PROCEDURE BLOOD CARDIOPLEGIA WAS USED INTERMITTENTLY EVERY 20 MINUTES, THE PATIENT WAS COOLED TO APPROXIMATELY 30 ºC, AND THE HEART WAS NOTED AS BEING COMPLETELY ARRESTED DURING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE CLAMPING TIME WAS GREATER THAN 3 HOURS. AT THE END OF THE PROCEDURE THERE WAS SOME ACTIVITY IN ECG BUT VERY LITTLE CONTRACTILITY FROM THE VENTRICLE. THE TEAM COULD NOT WEAN THE PATIENT FROM THE CPB AND WAS PUT UNDER ECMO, EXPIRING ON POST OPERATIVE DAY TWO. IT WAS REPORTED THAT THE HEART DID NOT FUNCTION ANYMORE (STONE HEART). THE PATIENT PRESENTED CERTAIN HYPERTROPHY BUT NOT FULLY HYPERTROPHIC. THE INTRACLUDE WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582112 INTRACLUDE AORTIC OCCLUSION DEVICE CLAMP, VASCULAR DXC EDWARDS LIFESCIENCES ICF100

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death