BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X MITRAL CONFORM 25/33

    MDR report key: 8409972 · Received March 11, 2019

    Report

    Report Number
    1649833-2019-00013
    Event Type
    Injury
    Date Received
    March 11, 2019
    Date of Event
    February 22, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A ROOT CAUSE FOR THE REPORTED EVENT IS THE PATIENT¿S KNOWN MEDICAL CONDITION OF THROMBOPHILIA BASED UPON THE REVIEW OF ALL REPORTS. THE MANUFACTURING RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET SPECIFICATIONS PRIOR TO RELEASE. THROMBOEMBOLIC EVENTS ARE A RECOGNIZED RISK FACTOR FOR MECHANICAL HEART VALVE REPLACEMENT. THE RISK MANAGEMENT FILE 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. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ON-X LIFE TECHNOLOGIES, INC. AND THE IFU ADEQUATELY COMMUNICATES RISK. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, IMPLANTATION OF AN ON-X MITRAL VALVE 25/33 IN A 48 YEAR OLD FEMALE PATIENT ON (B)(6) 2019. APPROXIMATELY ONE WEEK AFTER IMPLANTATION WHILE THE PATIENT WAS RECEIVING HIGH DOSES OF HEPARIN, THE ON-X VALVE HAS BEEN EXPLANTED AND REPLACED WITH A BIOLOGICAL PROSTHESIS DUE TO THROMBUS FORMATION. THE PATIENT HAS BEEN DIAGNOSED WITH THROMBOPHILIC PREDISPOSITION. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION AFTER MULTIPLE ATTEMPTS WENT UNMET.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORT, IMPLANTATION OF AN ON-X MITRAL VALVE 25/33 IN A (B)(6) FEMALE PATIENT ON (B)(6) 2019. APPROXIMATELY ONE WEEK AFTER IMPLANTATION WHILE THE PATIENT WAS RECEIVING HIGH DOSES OF HEPARIN. THE ON-X VALVE HAS BEEN EXPLANTED AND REPLACED WITH A BIOLOGICAL PROSTHESIS DUE TO THROMBUS FORMATION. THE PATIENT HAS BEEN DIAGNOSED WITH THROMBOPHILIC PREDISPOSITION. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201974 ON-X MITRAL CONFORM 25/33 HEART VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXMC-25/33

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R