BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 1753817 · Received May 18, 2010

    Report

    Report Number
    1649833-2010-00006
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    March 16, 2010
    Report Date
    May 17, 2010
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS RETURNED TO THE DISTRIBUTOR WHO SUBMITTED IT TO AN INDEPENDENT SURGEON, DR (B)(6), FOR FURTHER EVALUATION. DR'S (B)(6) FINDINGS ARE A CONFIRMATION OF THE THROMBOSIS REPORTED BY THE SURGEON, PLUS THAT THE CLOT WAS NOT IN THE HINGES. PHOTOS WERE PROVIDED. BECAUSE OF THE INDEPENDENT REVIEW, THE VALVE IS NOT NEEDED FOR FURTHER EVALUATION, AS IT IS DEEMED THERE IS NOTHING FURTHER TO LEARN. THEREFORE, A FOLLOW-UP REPORT IS NOT REQUIRED.

    Description of Event or Problem · 1

    VALVE THROMBOSIS OF THE ON-X MITRAL VALVE PROSTHESIS. PATIENT PRESENTED WITH ATRIAL FIBRILLATION, HAD PULMONARY EDEMA, WAS CLASS 4 DISABLED. PREVIOUS MITRAL VALVE FROM 1991, THEN THE CURRENT VALVE IN THE PATIENT WAS PUT IN (B)(6) 2008. PATIENT REGARDED AS HAVING GOOD ANTICOAGULATION COMPLIANCE BUT DIFFICULT TO CONTROL INR. PER SURGEON OPERATIVE NOTES, SURGEON STATES: "ONE LEAFLET OF THE MECHANICAL PROSTHESIS WAS COVERED BY A THIN LAYER OF FRESH CLOT. THIS WAS NOW EXTENDING TOWARDS THE SECOND LEAFLET." PER AATS/STS GUIDELINES, THROMBOSIS IS DEFINED TO BE VALVE-RELATED. REPLACED WITH A TISSUE VALVE. PATIENT RECOVERED THE SURGERY. TRANSFERRED TO ICU IN STABLE CONDITION. DIED EARLY THE NEXT MORNING. ANESTHESIOLOGIST ATTENDING HER SAID HE COULD NOT VENTILATE HER ADEQUATELY. HER BP DROPPED TO 60 SYSTOLIC. NO OTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-X MITRAL PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXMC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| R