BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 5001650 · Received August 11, 2015

    Report

    Report Number
    1649833-2015-00017
    Event Type
    Death
    Date Received
    August 11, 2015
    Date of Event
    October 22, 2012
    Report Date
    August 10, 2015
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001280
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AATS/STS GUIDELINES DEFINES VALVE-RELATED MORTALITY AS REPORTABLE. THEREFORE, THIS IS BEING REPORTED. THIS IS AN EXPECTED ADVERSE EVENT AND IS OCCURRING WITHIN EXPECTED RATE. NO TREND IS SEEN. NO AUTOPSY WAS DONE AND VALVE NOT EXPLANTED. REVIEW OF DEVICE HISTORY RECORDS FOR THIS VALVE SHOWS THE VALVE WAS BUILT PER SPECIFICATIONS.

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6). TENTH POST-OP DAY, PATIENT DEATH. JUDGED AS OPERATIVE MORTALITY, PROBABLY "SUDDEN". BACKGROUND: DOUBLE-VALVE PATIENT. DISEASE ETIOLOGY: ENDOCARDITIS. NYHA CLASS III. MITRAL REGURGITATION AND AORTIC REGURGITATION. EMERGENCY VALVE REPLACEMENT, AORTIC AND MITRAL. PATIENT NOT ON ANTICOAGULATION ON SURGERY DATE. ON JULY 21, 2015, ONXLTI RECEIVED A SET OF DATA FROM THE SPONSOR OF A (B)(4) STUDY, WHERE-IN THEY WANTED ON-X TO DO DATA ANALYSIS ON A SET OF DATA CONTAINING ADVERSE EVENTS. THE VALVE ON THIS MDR IS ONE OF THE AE'S. THERE ARE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN THESE RATES AND THIS TRIAL WAS RUN AT INR OF 1.5 TO 2.5 VERSUS THE PMA AT 2.0 TO 3.0. AT LOWER INR LO RATES ARE EXPECTED BASED ON OUR RESEARCH. SO THESE EVENTS WHILE MDR REPORTABLE AS INDIVIDUAL OCCURRENCES, THEY ARE OVERALL IN THE RANGE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525691 ON-X MITRAL PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXM 00851788001280

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death