BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX ASCENDING AORTIC 19

    MDR report key: 12351707 · Received August 20, 2021

    Report

    Report Number
    1649833-2021-00032
    Event Type
    Injury
    Date Received
    August 20, 2021
    Report Date
    October 18, 2021
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, "19 MM OMX VALVE CONDUIT IMPLANTED JAN 21 -ADMITTED WITH GRADIENTS MUCH HIGHER(MEAN 14>>22) THAN IN MARCH AND SOME TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) EVIDENCE OF THROMBUS ON LEAFLETS AND SYMPTOMATIC SOB (SHORTNESS OF BREATH). - SHE HAS LARGE BSA (BODY SURFACE AREA) 1.8 AND CERTAINLY SOME PPM BUT INTRAOOPERATIVE GRADIENT MEAN 14 AND STABLE IN MARCH ON TTE. - INR (INTERNATIONAL NORMALIZED RATIO) HAS BEEN SUB THERAPEUTIC AROUND 1.4 RANGE"

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORT, "19 MM OMX VALVE CONDUIT IMPLANTED JAN 21 -ADMITTED WITH GRADIENTS MUCH HIGHER(MEAN 14>>22) THAN IN MARCH AND SOME TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) EVIDENCE OF THROMBUS ON LEAFLETS AND SYMPTOMATIC SOB (SHORTNESS OF BREATH). - SHE HAS LARGE BSA (BODY SURFACE AREA) 1.8 AND CERTAINLY SOME PPM BUT INTRAOOPERATIVE GRADIENT MEAN 14 AND STABLE IN MARCH ON TTE. - INR (INTERNATIONAL NORMALIZED RATIO) HAS BEEN SUB THERAPEUTIC AROUND 1.4 RANGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245062 ONX ASCENDING AORTIC 19 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAAP-19

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening