BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90

    MDR report key: 22155669 · Received June 5, 2025

    Report

    Report Number
    2124215-2025-36852
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    January 1, 2012
    Report Date
    June 5, 2025
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZHAO, K.; SON, S.; KARIMI, A.; MARINELLI, B.; ERINJERI, J.P.; ALEXANDER, E.S.; SOTIRCHOS, V.S.; HARDING, J.J.; SOARES, K.C.; ZIV, E.; ET AL. OUTCOMES OF Y90 RADIOEMBOLIZATION FOR HEPATOCELLULAR CARCINOMA IN PATIENTS PREVIOUSLY TREATED WITH TRANSARTERIAL EMBOLIZATION. CURR. ONCOL. 2024, 31, 2650-2661. HTTPS://DOI.ORG/10.3390/CURRONCOL31050200. CODE E2402 WAS USED TO DENOTE POST EMBOLIZATION SYNDROME. 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 NEW ASCITES OCCURRED AFTER TARE IN SIX PATIENTS AND THREE REQUIRED TREATMENTS. THE AIM OF THIS STUDY WAS TO EVALUATE OUTCOMES OF TRANSARTERIAL RADIOEMBOLIZATION (TARE) FOR HEPATOCELLULAR CARCINOMA (HCC) IN 21 PATIENTS PREVIOUSLY TREATED WITH TRANSARTERIAL EMBOLIZATION (TAE). AT FOLLOW-UP PERIODS, ADVERSE EVENTS WERE REPORTED ATTRIBUTABLE TO TARE. GRADE 1-2 ADVERSE EVENTS WERE REPORTED AS INCREASE IN LIVER VALUES IN 10 PATIENTS, HEMATOLOGICAL TOXICITY (RBC, WBC, PLATELETS, RENAL TOXICITY) IN 15 PATIENTS, CLINICAL ADVERSE EVENTS (NAUSEA, FATIGUE, ABDOMINAL PAIN, ETC.) IN 5 PATIENTS, AND PROCEDURE RELATED ACCESS (HEMATOMA, PSEUDOANEURYSM, EXTRAVASATION) IN A SINGLE PATIENT. THREE PATIENTS EXPERIENCED NEW ONSETS OF ASCITES (GRADE 3), HALF WERE SYMPTOMATIC REQUIRING PARACENTESIS. NO GRADE 4 OR 5 ADVERSE EVENTS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604038 THERASPHERE Y-90 MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention