BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X AORTIC PROSTHETIC HEART VALVE

    MDR report key: 5001656 · Received August 11, 2015

    Report

    Report Number
    1649833-2015-00019
    Event Type
    Death
    Date Received
    August 11, 2015
    Date of Event
    February 23, 2014
    Report Date
    August 10, 2015
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001426
    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 PARAVALVULAR LEAK AND ENDOCARDITIS 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 OCCURED IN (B)(6). PATIENT DEATH, POST-OP LATE (5 MONTHS). BACKGROUND: DISEASE ETIOLOGY: PROSTHETIC VALVE (NOT AN ON-X VALVE) DEHISCED DUE TO INFECTIVE ENDOCARDITIS (IE) IN (B)(6) 2012. PATIENT HAD STOPPED TAKING WARFARIN. EMERGENCY RE-DO AORTIC VALVE REPLACEMENT ON (B)(6) 2013 W/ ON-X VALVE. UPON DISCHARGE DATE 12/26/2013, ECHO SHOWED GRADE II AORTIC REGURG. (TRANS + PERIVALVULAR). INR=1.76, NYHA CLASS I, SLDH =205. PATIENT DIED (B)(6) 2014, RECORDED AS VALVE-RELATED DUE TO PREVIOUSLY-DESCRIBED DISEASE ETIOLOGY. IT IS NOT CLEAR IF THE ON-X VALVE ALSO DEHISCED DUE TO IE. ON (B)(6) 2015, ONXLTI RECEIVED A SET OF DATA FROM THE SPONSOR OF A (B)(6) POST-MARKET 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. SEE SCANNED CHART. 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
    525173 ON-X AORTIC PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAE 00851788001426

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death