BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 2464167 · Received February 17, 2012

    Report

    Report Number
    1649833-2012-00004
    Event Type
    Death
    Date Received
    February 17, 2012
    Date of Event
    January 28, 2012
    Report Date
    February 17, 2012
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE IS NOT AVAILABLE FOR RETURN TO MFR, THEREFORE, A COMPLETE INVESTIGATION IS NOT POSSIBLE. IF THE VALVE BECOMES AVAILABLE FOR INVESTIGATION, THE PRELIMINARY INVESTIGATION PLAN INCLUDES PATHOLOGY ANALYSIS. DISTRIBUTOR PROVIDED PHOTOS FROM HOSPITAL. THE PHOTOS CLEARLY REVEAL TISSUE IN BOTH SETS OF HINGES, LIKELY TO BE THROMBUS. A HOSPITAL PATHOLOGY REPORT IS TO BE ISSUED AND SHARED WITH ON-X. IT WAS LEARNED IN LATER DISCUSSION WITH SURGEON THAT ENDOCARDITIS COULD NOT BE RULED OUT. THE ROUTE OF INFECTION COULD NOT BE DETERMINED. CLARIFICATION: THE PATHOLOGY REPORT WAS DONE BY THE HOSPITAL. THE VALVE WAS NEVER RETURNED TO ON-X. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS VALVE SHOWED THAT THE VALVE WAS BUILT PER SPECIFICATIONS. AS THE INFO FROM THE USER FACILITY IS COMPREHENSIVE AND IT IS KNOWN THAT THE VALVE WILL NOT BE RETURNED FOR ANY FURTHER ANALYSIS BY ON-X, THIS MDR IS EXPECTED TO BE THE ONLY REPORT (I.E., NO F/U EXPECTED TO BE NEEDED).

    Description of Event or Problem · 1

    IN ACCORDANCE WITH AATS/STS GUIDELINES, THE RE-OPERATION AND EVENTUAL PT DEATH ARE REPORTABLE AS VALVE-RELATED. UPON RE-OP, BOTH LEAFLETS FOUND TO BE RESTRICTED IN CLOSED POSITION DUE TO CLOTS AT PIVOT AREAS. VALVE WAS EXPLANTED AND REPLACED. A VIRAL INFECTION WAS CONFIRMED AT RE-OPERATION. CONCLUSION BASED UPON AVAILABLE INFO IS VALVE THROMBOSIS SECONDARY TO ENDOCARDITIS. PT OUTCOME: DEATH ON (B)(6) 2012. SURGEON'S COMMENT AS TO CAUSE OF DEATH: PROLONGED CARDIAC DEPRESSION AND LOW CARDIAC OUTPUT. OTHER CONTRIBUTORY FACTOR IS THE PROLONGED CARDIAC ARREST DUE TO RE-OP. HOSPITAL PATHOLOGY LAB RESULT ON TISSUE IN THE ON-X VALVE PIVOTS: THE TISSUE WAS FOUND TO BE THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-X MITRAL PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXM

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention