BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER -25MM

    MDR report key: 5995201 · Received October 3, 2016

    Report

    Report Number
    1649833-2016-00018
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    December 10, 2015
    Report Date
    October 3, 2016
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC
    Product Code
    LWQ
    UDI-DI
    00851788001471
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE INITIAL REPORT FOR 1649833-2016-00016 SUBMITTED 09/16/2016 CONTAINED INFORMATION FOR THE WRONG PRODUCT AND WAS UPDATED IN THIS FOLLOW-UP REPORT. IN 2016, ON-X TECHNOLOGIES INCORPORATED (ON-X) BECAME A WHOLLY OWNED SUBSIDIARY OF CRYOLIFE, INC. (CRYOLIFE). A RETROSPECTIVE REVIEW OF THE ON-X COMPLAINT SYSTEM WAS PERFORMED TO IDENTIFY ANY AREAS REQUIRING ADDITIONAL ACTION AND TO APPROPRIATELY ASSIMILATE THE ON-X PROCESS INTO THE CRYOLIFE QUALITY MANAGEMENT SYSTEM. IN AN ABUNDANCE OF CAUTION THIS MDR IS BEING REPORTED TO SATISFY REGULATORY REPORTING OBLIGATIONS. OPERATED VALVE ENDOCARDITIS IS A RECOGNIZED RISK OF PROSTHETIC VALVES THAT COULD LEAD TO THROMBOSIS, THROMBOTIC EMBOLISM, BLEEDING EVENTS, OR PARAVALVULAR LEAK [AKINS 2008]. THE OBJECTIVE PERFORMANCE CRITERIA OF ISO 5840 FOR RIGID PROSTHETIC VALVES INDICATES AN ENDOCARDITIS RATE OF 1.2 %/PT-YR. IN THE PROACT STUDY FOR AVR , THERE WERE 9 REPORTED CASES OUT OF 375 IMPLANTS [PUSKAS 2014). ENDOCARDITIS OF PROSTHESIS IS AN INFREQUENT, BUT KNOWN RISK OF AORTIC VALVE REPLACEMENT USING PROSTHETIC HEART VALVES. ENDOCARDITIS IS A KNOWN POTENTIAL COMPLICATION LISTED IN THE INSTRUCTIONS FOR USE (IFU). FURTHERMORE, THIS COMPLICATION IS NOT UNIQUE TO THE ON-X DEVICE AND IS A RISK ASSOCIATED WITH ALL MECHANICAL HEART VALVES. ALL OBSERVED RISKS ARE MITIGATED IN THE LABELING AND IFU. NO FURTHER ACTION REQUIRED. WITHOUT RETURN OF THE VALVE, A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IMPLANT RECOVERY CARDS RECEIVED INDICATE THAT PATIENT IMPLANTED WITH ONXACE-25 (4824304, VALVE 1) ON (B)(6) 2015 INDICATED FOR AORTIC VALVE REGURGITATION AND BACTERIAL ENDOCARDITIS. RE-INTERVENTION AND EXPLANT REQUIRED ON (B)(6) 2015 FOR BACTERIAL ENDOCARDITIS, REPLACED WITH ONXACE-23 (4945312, VALVE 2). ADDITIONAL RE-INTERVENTION/EXPLANT REQUIRED ON (B)(6) 2015 INDICATED FOR "4+ AORTIC INSUFFICIENCY WITH A ROCKING AORTIC VALVE SUGGESTING DEHISCENCE" AND REPLACED WITH ONXACE-23 (3926503). THIS REPORT IS RELEGATED TO VALVE 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645935 ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER -25MM MECHANICAL VALVE CONDUIT LWQ ON-X LIFE TECHNOLOGIES, INC ONXACE-25 00851788001471

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| O