BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X AORTIC VALVE UNKNOWN CONFIGURATION

    MDR report key: 12307950 · Received August 11, 2021

    Report

    Report Number
    1649833-2021-00026
    Event Type
    Injury
    Date Received
    August 11, 2021
    Report Date
    August 11, 2021
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001655
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, "I RECEIVED A CALL TODAY FROM A SURGEON AT [HOSPITAL] STATING A PATIENT IS HAVING HEMOLYSIS AND HE (THE PATIENT) THINKS IT¿S BECAUSE OF THE ON-X HEART VALVE." ADDITIONAL INFORMATION WAS PROVIDED: 1. PRODUCT CODE AND SERIAL NUMBER OF THE VALVE? PROSTHESIS INSTALLED: ITEM: VALVE, IMPLANT STERILITY CHECKED (Y/N): YES, STERILITY EXPIRATION DATE: JAN 17, 2024, RN VERIFIER: [XXX], VENDOR: ON-X LIFE TECHNOLOGIES, INC., MODEL: ONXANE, LOT NUMBER: NONE, SERIAL NUMBER: (B)(4), STERILE RESP: MANUFACTURER, SIZE: 21MM. 2. INITIAL DATE OF SURGERY? (B)(6) 2018. 3. REASON FOR IMPLANTATION OF VALVE? SEVERE AORTIC INSUFFICIENCY. 4. DATE THE HEMOLYSIS WAS DIAGNOSED? UNKNOWN. 5. ACTION TAKEN BY SURGEON TO ADDRESS THE HEMOLYSIS? NONE. 6. HOW IS THE PATIENT CURRENTLY DOING? STILL GETTING PERIODIC IRON TRANSFUSIONS. 7. ARE OPERATIVE NOTES AVAILABLE FOR REVIEW? NO ADDITIONAL INFORMATION FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206787 ON-X AORTIC VALVE UNKNOWN CONFIGURATION HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXANE-21 00851788001655

    Patients

    Seq Age Sex Outcome Treatment
    1 Other