BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X MITRAL HEART VALVE WITH STANDARD SEWING RING - 25MM

    MDR report key: 5956038 · Received September 16, 2016

    Report

    Report Number
    1649833-2016-00047
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    August 14, 2015
    Report Date
    October 4, 2016
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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 (B)(6) 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.

    Description of Event or Problem · 1

    IMPLANT RECOVERY CARDS RECEIVED INDICATE THAT PATIENT IMPLANTED WITH ONXACE-19 AND ONXM-25 ON (B)(6) 2009 AND REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2014 WITH REPLACEMENT VIA ONXACE-21 AND ONXM-27/29 INDICATED FOR AORTIC AND MITRAL PROSTHETIC VALVE ENDOCARDITIS WITH ASCENDING AORTIC ANEURYSM. THIS REPORT IS RELEGATED TO THE ONXM-25 VALVE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER VALVE.

    Description of Event or Problem · 1

    IMPLANT RECOVERY CARDS RECEIVED INDICATE THAT PATIENT IMPLANTED WITH ONXACE-19 AND ONXM-25 ON (B)(6) 2009 AND REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2014 WITH REPLACEMENT VIA ONXACE-21 AND ONXM-27/29 INDICATED FOR AORTIC AND MITRAL PROSTHETIC VALVE ENDOCARDITIS WITH ASCENDING AORTIC ANEURYSM. THIS REPORT IS RELEGATED TO THE ONXM-25 VALVE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607421 ON-X MITRAL HEART VALVE WITH STANDARD SEWING RING - 25MM MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC ONXM-25

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| O