BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5967521 · Received September 21, 2016

    Report

    Report Number
    1649833-2016-00019
    Event Type
    Injury
    Date Received
    September 21, 2016
    Date of Event
    June 27, 2016
    Report Date
    September 21, 2016
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC
    Product Code
    LWQ
    UDI-DI
    00851788001457
    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. THE ON-X 614 HEART VALVE DESIGN FMEA 940816 01 REV S THOROUGHLY IDENTIFIES THE PROCESS AND PRODUCT HAZARDS FOR APPROVED INDICATIONS. EACH INDIVIDUAL HAZARD IS MITIGATED AND REDUCED AS LOW AS POSSIBLE BY DESIGN AND PROCESS. POST PRODUCTION RESIDUAL RISK IS COMMUNICATED IN THE PRODUCT'S LABELING AND INSTRUCTION FOR USE (IFU). ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH THE USE OF PROSTHETIC HEART VALVES INCLUDE PROSTHESIS LEAFLET ENTRAPMENT (IMPINGEMENT) AND CARDIAC ARRHYTHMIA.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT WAS IMPLANTED WITH A SIZE 21MM ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER. THE 21MM WAS TOO TIGHT AND WAS CAUSING IMPINGEMENT. THE PATIENT WAS PLACED BACK ON THE PUMP AND WENT INTO HEART BLOCK. A SIZE 19MM ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER WAS IMPLANTED DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617325 ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC ONXACE-21 00851788001457

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other