BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT

    MDR report key: 24603865 · Received March 16, 2026

    Report

    Report Number
    1649833-2026-00009
    Event Type
    Injury
    Date Received
    March 16, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ONX LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001532
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. 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 ARTIVION- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, A PATIENT RECEIVED AN ONXAAP-25 VALVE IMPLANT IN (B)(6) 2025. SHORTLY AFTER IMPLANTATION, THE PATIENT DEVELOPED HEMOLYTIC ANEMIA, WHICH REQUIRES ONGOING MONTHLY BLOOD TRANSFUSIONS. THE PATIENT ALSO HAS A WORSENING VALVE GRADIENT AS REPORTED BY THE CARDIOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23361 ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT HEART-VALVE, MECHANICAL LWQ ONX LIFE TECHNOLOGIES, INC. ONXAAP-25 00851788001532

    Patients

    Seq Age Sex Outcome Treatment
    1