BEUDAMED
    FDA Adverse Event Death Summary report: N

    Y-90 THERASPHERE (3 GBQ) CANADA COMM

    MDR report key: 12061308 · Received June 24, 2021

    Report

    Report Number
    2134265-2021-08012
    Event Type
    Death
    Date Received
    June 24, 2021
    Date of Event
    September 14, 2018
    Report Date
    June 24, 2021
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF IMPLANT IS UNKNOWN. IMPLANT DATE IS ESTIMATED TO THE FIRST DAY OF THE MONTH OF IMPLANT. ZHANG, J.-W., YU, Z.-Y., LI, H.-B., YI, S.-H., LIU, W., YANG, Y., & WANG, G.-Y. (2021). SEVERE BILE DUCT COMPLICATION AFTER YTTRIUM-90 RADIOEMBOLIZATION THERAPY IN A PATIENT WITH RECURRENT HEPATOCELLULAR CARCINOMA AFTER LIVER TRANSPLANTATION: A CASE REPORT. LIVER RESEARCH, 5(1), 33,35. HTTPS://DOI.ORG/10.1016/J.LIVRES.2020.10.002.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT A DEATH OCCURRED. CASE REPORT: PATIENT WITH HEPATOCELLULAR CARCINOMA (HCC) WAS TREATED WITH THERASPHERE Y90 MICROSPHERES. APPROXIMATELY, FOUR WEEKS POST PROCEDURE, THE PATIENTS LIVER FUNCTION GRADUALLY DETERIORATED FOR WHICH HE WAS HOSPITALIZED. HIGH BODY TEMPERATURE AND ABDOMINAL DISTENTION WERE ALSO NOTED. AT THIS TIME, PATIENT WAS DIAGNOSED WITH ISCHEMIC-TYPE BILIARY LESION INDUCED BY RADIOEMBOLIZATION. PATIENT WAS TREATED WITH LIVER PROTECTION THERAPY, CHOLERETIC THERAPY, BILIARY MICROCIRCULATION IMPROVEMENT TREATMENT, AND NUTRITIONAL SUPPORT. SYMPTOMS DID NOT IMPROVE AND RENAL FUNCTION DECLINED. ALPHA FETOPROTEIN LEVELS INCREASED AND COMPUTED TOMOGRAPHY AND MAGNETIC RESONANCE IMAGING SHOWED WORSENING OF HEPATIC LESIONS AND ISCHEMIC CHOLANGITIS. APPROXIMATELY 12 WEEKS LATER, THE PATIENT CONTINUED TO DECLINE AND DEVELOPED A SEVERE UPPER GASTROINTESTINAL HEMORRHAGE AND PASSED AWAY TWO DAYS LATER. THE CAUSE OF DEATH ON THE DEATH CERTIFICATE WAS SEVERE GASTROINTESTINAL BLEEDING CAUSE BY LIVER FAILURE, BILE DUCT INJURE, LIVER MALIGNANCY RECURRENCE AFTER LIVER TRANSPLANTATION , LUNG METASTASES, AND THORACOLUMBAR METASTASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956919 Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death