BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90

    MDR report key: 22149708 · Received June 5, 2025

    Report

    Report Number
    2124215-2025-36951
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    September 27, 2023
    Report Date
    June 5, 2025
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NUCLEAR MEDICINE COMMUNICATIONS 2024, VOL 45 NO 4. 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 VIA LITERATURE ARTICLE THAT ONE CASE RESULTED IN RECHT AFTER THE THIRD TARE TREATMENT. THIS ARTICLE INDICATED THERE IS LACK OF SUFFICIENT EVIDENCE REGARDING THE USE OF EXTENDED SHELF-LIFE (EXSL) YTTRIUM-90 (90Y) GLASS RADIOMICROSPHERES IN METASTATIC COLORECTAL CANCER (MCRC) PATIENTS. WE AIMED TO INVESTIGATE THE EFFICACY OF EXSL 90Y GLASS RADIOMICROSPHERES WITH A PERSONALIZED TREATMENT APPROACH BY ANALYZING 18F-FDG PET/CT QUANTITATIVE PARAMETERS [METABOLIC TUMOR VOLUME (MTV) AND TOTAL LESION GLYCOLYSIS (TLG)] SEPARATELY BEFORE AND AFTER THE TREATMENT. A TOTAL OF 93 RADIOEMBOLIZATION SESSIONS INVOLVING 77 PATIENTS WERE INCLUDED. RADIOEMBOLIZATION-INDUCED LIVER DISEASE (REILD) WAS DEFINED AS A SYMPTOMATIC DETERIORATION IN LIVER FUNCTION OCCURRING BETWEEN 2 WEEKS AND 2 MONTHS AFTER TARE, WITHOUT TUMOR PROGRESSION OR BILIARY OBSTRUCTION. THE DIAGNOSIS OF RECHT INCLUDED ANY NEW, PERMANENT GRADE 3 OR HIGHER CLINICAL OR FUNCTIONAL LABORATORY HEPATOTOXICITY THAT COULD NOT BE ATTRIBUTED TO DISEASE PROGRESSION OR OTHER CONFOUNDING THERAPIES. THE EVALUATION OF THE DOSE-TOXICITY PROFILE, REVEALED THAT EXSL 90Y GLASS MICROSPHERE THERAPY DID NOT PRESENT ANY ADDITIONAL SIDE EFFECTS/VITAL RISKS THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. A FEW CASES HAD GRADE 3 ABDOMINAL PAIN AND NAUSEA. ONE CASE SHOWED REILD AFTER THE THIRD TARE TREATMENT, WHILE ANOTHER CASE SHOWED RECHT AFTER THE THIRD TARE SESSION. AMONG THE 12 CASES THAT DIED WITHIN THE FIRST 6 MONTHS, A DETAILED ANALYSIS REVEALED THAT PROGRESSION OF THE PRIMARY DISEASE SIGNIFICANTLY CONTRIBUTED TO MORTALITY IN 11 CASES. NO DETAILS WERE PROVIDED ON THE OTHER CAUSE OF DEATH. TWO CASES WERE FOUND TO HAVE A BILE LEAK, AND FOR ONE OF THESE CASES, CHOLECYSTECTOMY WAS PLANNED AS A RESULT OF THIS COMPLICATION THAT OCCURRED AFTER THE SECOND SESSION OF TARE. FURTHERMORE, THIS CASE ACHIEVED A COMPLETE METABOLIC RESPONSE AS A RESULT OF THESE TWO SESSIONS OF TARE. FOR SIX CASES, PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE WAS REQUIRED WITHIN THE FIRST SIX MONTHS DUE TO TUMOR PROGRESSION/MASS EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50750 THERASPHERE Y-90 MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown