BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90

    MDR report key: 23706680 · Received December 3, 2025

    Report

    Report Number
    2124215-2025-88408
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    July 2, 2024
    Report Date
    December 3, 2025
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D3/G1: GU9 8QL. E1 - (B)(6). 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 STUDY SUBJECT EXPERIENCED DECREASED WHITE BLOOD CELL COUNT REQUIRING MEDICATION. ON (B)(6) 2024, THE SUBJECT WAS RANDOMIZED TO THE STUDY. PLANNED TREATMENT TYPE WAS UNI-LOBAR TREATMENT. TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. 99M-TC MAA (MACROAGGREGATED ALBUMIN) ANGIOGRAM WAS PERFORMED, AND TARGET VOLUME WAS 117 CM3. 2.03 GBQ WAS ADMINISTERED THROUGH 1 DOSE VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS REPORTED AS 0.1 GBQ, THERASPHERE DELIVERY TO PERFUSED TARGET NORMAL LIVER TISSUE WAS 90.6 GY, TOTAL RADIATION DOSE TO LUNGS WAS 5 GY, CUMULATIVE RADIATION TO LUNGS WAS 5 GY, AND DOSE TO PERFUSED TARGET TUMOR TISSUE WAS 383 GY. ON (B)(6) 2024, 5 DAYS POST INDEX PROCEDURE, THE SUBJECTS LABORATORY EXAMINATION REVEALED DECREASED WHITE BLOOD CELL COUNT. IT WAS REPORTED THAT MEDICATION WAS GIVEN OR REGIMEN WAS ADJUSTED TO TREAT THE EVENT, ON (B)(6) 2024, 31-DAY POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH INCREASED VALUE OF BLOOD LACTATE DEHYDROGENASE AND GAMMA-GLUTAMYL TRANSFERASE (GGT). NO ACTION WAS TAKEN TO TREAT THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2853311 THERASPHERE Y-90 MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention