BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5995188 · Received October 3, 2016

    Report

    Report Number
    1649833-2016-00022
    Event Type
    Injury
    Date Received
    October 3, 2016
    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

    (B)(4). 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). REOPERATION IS A KNOWN COMPLICATION OF PROSTHETIC VALVE IMPLANTATION AND IS LISTED IN THE IFU. WITHOUT RETURN OF THE VALVE, A SPECIFIC RISK CANNOT BE IDENTIFIED.

    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). REOPERATION IS A KNOWN COMPLICATION OF PROSTHETIC VALVE IMPLANTATION AND IS LISTED IN THE IFU. WITHOUT RETURN OF THE VALVE, A SPECIFIC RISK CANNOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IMPLANT RECOVERY CARDS RECEIVED INDICATED THAT PATIENT RECEIVED ONXACE-25 SOMETIME IN 2015 WHICH REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2016 AND REPLACEMENT WITH AN ONXACE-27/29 FOR UNSPECIFIED REASON. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

    Description of Event or Problem · 1

    IMPLANT RECOVERY CARDS RECEIVED INDICATED THAT PATIENT RECEIVED ONXACE-25 SOMETIME IN 2015 WHICH REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2016 AND REPLACEMENT WITH AN ONXACE-27/29 FOR UNSPECIFIED REASON. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645810 ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDER HOLDER - 25MM MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC ONXACE-25 00851788001471

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O