BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE (3 GBQ) CANADA COMM

    MDR report key: 12100146 · Received July 1, 2021

    Report

    Report Number
    2134265-2021-08306
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    January 1, 2005
    Report Date
    July 1, 2021
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PAN, M. M., GABR, A., RIAZ, A., MOULI, S., SALEM, R., & LEWANDOWSKI, R. J. (2021). DOES SIGNIFICANTLY ELEVATED LUNG SHUNT FRACTION (LSF >20 PERCENT) PROMOTE EXTRAHEPATIC PROGRESSION IN PATIENTS WITH HEPATOCELLULAR CARCINOMA TREATED WITH RADIOEMBOLIZATION? NUCLEAR MEDICINE COMMUNICATIONS, 42(7), 725,731. HTTPS://DOI.ORG/10.1097/MNM.0000000000001392.

    Description of Event or Problem · 1

    LITERATURE: IT WAS REPORTED THAT PATIENT COMPLICATIONS OCCURRED. A RETROSPECTIVE COHORT STUDY WAS CONDUCTED TO EXAMINE THE RATE AND THE PATTERN OF METASTASIS DEVELOPMENT, ADVERSE EVENTS AND OVERALL SURVIVAL (OS) IN A PATIENT COHORT WITH HEPATOCELLULAR CARCINOMA (HCC) AND ELEVATED LUNG SHUNT FRACTION (LSF <20 PERCENT) THAT UNDERWENT Y90 RADIOEMBOLIZATION. TWENTY THREE PATIENTS MET INCLUSION CRITERIA AND WERE TREATED BETWEEN 2005 AND 2016. MANY PATIENTS EXPERIENCES INTERMITTENT MINOR FATIGUE, NAUSEA, ANOREXIA, AND ABDOMINAL PAIN. ONE PATIENT DEVELOPED A BLEEDING GASTRIC ULCER REQUIRING HOSPITALIZATION. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997447 Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE NAW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention