BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X MITRAL HEART VALVE WITH CONFORM-X SEWING RING - 25/33

    MDR report key: 5995401 · Received October 3, 2016

    Report

    Report Number
    1649833-2016-00034
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    October 22, 2015
    Report Date
    October 3, 2016
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC
    Product Code
    LWQ
    UDI-DI
    00851788001303
    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). 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 CARD (IRC) RECEIVED INDICATES THAT PATIENT RECEIVED ONXMC-25/33 ON (B)(6) 2011 WHICH REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2015 AND REPLACEMENT WITH ANOTHER ONXMC-25/33 FOR UNSPECIFIED REASON. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL CLARIFYING INFORMATION WERE MADE WITHOUT SUCCESS. CONVERSATION WITH THE INTERVENING PHYSICIAN ON (B)(6) 2016 INDICATE THAT DESPITE THE IRC INDICATING IMPLANT OF TWO VALVES, "OP-NOTES SHOW THIS AS BEING THE FIRST ON-X IMPLANT FOR THE PATIENT." ADDITIONALLY, "AS OF (B)(6) 2016 PATIENT IS DOING WELL AND WORKING OUT ON A TREADMILL REGULARLY. PATIENT IS ON MEDICATION FOR CHOLESTEROL." THE DOCTOR'S OFFICE WOULD NOT RELEASE OPERATIVE NOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645830 ON-X MITRAL HEART VALVE WITH CONFORM-X SEWING RING - 25/33 MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC ONXMC- 25/33 00851788001303

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| O