BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90

    MDR report key: 25023642 · Received April 28, 2026

    Report

    Report Number
    2124215-2026-22286
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    January 1, 2016
    Report Date
    May 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT ESTIMATED TO BE THE FIRST DATE IN THE RANGE OF PROCEDURE DATES INCLUDED IN THIS STUDY. E1: INITIAL REPORTER PHONE: (B)(6). DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT LOT NUMBER IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI)#. CHOI, J. W., SUH, M., CHOI, Y., LEE, M., PAENG, J. C., & KIM, H.-C. (2025). YTTRIUM-90 GLASS MICROSPHERE RADIOEMBOLIZATION AS FRONTLINE TREATMENT FOR HEPATOCELLULAR CARCINOMA WITH LOCALIZED PORTAL VEIN INVASION. EUROPEAN RADIOLOGY, 36(1), 743-753. HTTPS://DOI.ORG/10.1007/S00330-025-11882-W.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT RADIATION EXPOSURE OCCURRED, CAUSING VARIOUS ADVERSE EFFECTS. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE OUTCOMES OF YTTRIUM-90 RADIOEMBOLIZATION (GLASS MICROSPHERES) IN PATIENTS WITH UNILOBAR HEPATOCELLULAR CARCINOMA (HCC) AND PORTAL VEIN INVASION (PVI) WHO HAVE PRESERVED LIVER FUNCTION. ALL PROCEDURES WERE PERFORMED FROM JANUARY 2016 AND JUNE 2023 BY ONE OF THREE RADIOLOGISTS. THE STUDY POPULATION OF 48 PATIENTS UNDERWENT PLANNING ANGIOGRAPHY USING CONE-BEAM CT AND 99MTC-MACROAGGREGATED ALBUMIN MAPPING, INCLUDING PLANAR IMAGING AND SPECT-CT, PRIOR TO YTTRIUM-90 (Y90) RADIOEMBOLIZATION (Y90-RE). THE TRACER WAS INJECTED INTO EITHER THE RIGHT OR LEFT LOBAR HEPATIC ARTERY, AND Y90-RE WAS PERFORMED USING THERASPHERE Y90 GLASS MICROSPHERES. Y90 PET-CT IMAGING WAS CONDUCTED 1 DAY AFTER EACH Y90-RE PROCEDURE. PATIENTS WERE ADVISED TO VISIT THE HOSPITAL FOR FOLLOW-UP AT 1 MONTH, 3 MONTHS, AND EVERY 3 MONTHS THEREAFTER POST-TREATMENT. THE ELECTRONIC MEDICAL RECORDS OF THE PATIENTS WERE RETROSPECTIVELY REVIEWED TO IDENTIFY POST-PROCEDURAL ADVERSE EVENTS OCCURRING WITHIN 90 DAYS. ADVERSE EVENTS WERE GRADED BASED ON THE NATIONAL CANCER INSTITUTES COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE). WITHIN 90 DAYS OF THE PROCEDURES, 16 OF THE 48 PATIENTS EXPERIENCED GRADE 3 OR HIGHER ADVERSE EVENTS. THE MOST COMMON EVENTS WERE A DECREASE IN LYMPHOCYTE COUNT AND ANEMIA. ONE CASE OF RADIATION PNEUMONITIS OCCURRED FOLLOWING Y90-RE WITH AN ESTIMATED LUNG DOSE OF 26.3 GY. THIS PATIENT DEVELOPED FEVER AND DYSPNEA 14 DAYS POST-TREATMENT AND WAS MANAGED WITH STEROID THERAPY. HOWEVER, 5 WEEKS LATER, WHILE TAPERING THE STEROIDS, THE PATIENT CONTRACTED SARS-COV-2, DEVELOPED ACUTE RESPIRATORY DISTRESS SYNDROME, AND EXPERIENCED GRADE 4 ELEVATIONS IN ASPARTATE AMINOTRANSFERASE AND ALANINE AMINOTRANSFERASE LEVELS. DESPITE INTENSIVE CARE UNIT MANAGEMENT FOR 19 DAYS, THE PATIENT EXPIRED DUE TO SARS-COV-2. ASIDE FROM THIS CASE, NO OTHER PATIENTS DIED WITHIN 3 MONTHS OF Y90-RE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349127 THERASPHERE Y-90 MICROSPHERES RADIONUCLIDE NAW BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention