BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90 (3 GBQ) CE MARK

    MDR report key: 22917389 · Received August 28, 2025

    Report

    Report Number
    2124215-2025-60205
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 28, 2025
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    UDI-DI
    05060116920284
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE NATURE OF THIS PRODUCT, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) AND OTHER PRODUCT SPECIFIC INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEPATIC DYSFUNCTION POST THERASPHERE ADMINISTRATION. A THERASPHERE Y-90 (3.0 GBQ) DOSE VIAL AND A THERASPHERE Y-90 (3.5 GBQ) WAS SELECTED FOR USE IN THE RADIOEMBOLIZATION PROCEDURE. THE PATIENT WAS BEING TREATED FOR HEPATOCELLULAR CARCINOMA (HCC). THIS WAS A BILOBAR TREATMENT. THE WAS NOTED TO BE MULTIFOCAL WITH A TOTAL TUMOR VOLUME OF 29.3ML. THERE WAS NOTHING UNUSUAL OBSERVED DURING DEVICE PREPARATION OR THE THERASPHERE PROCEDURE. FOLLOWING THERASPHERE ADMINISTRATION, LIVER FUNCTION TESTS (LFTS) REVEALED THAT THE PATIENT WAS EXPERIENCING HEPATIC DYSFUNCTION. AS A RESULT, THE PATIENT WAS ADMINISTERED REILD PROPHYLAXIS (PREDNISOLONE 10 MG/D, UDC 500 MG BID, LWH). THERE WERE NO FURTHER PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247973 THERASPHERE Y-90 (3 GBQ) CE MARK MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2361-02 05060116920284

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention THERASPHERE Y-90 (3.5 GBQ)