BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90 (10 GBQ) CE MARK

    MDR report key: 23882155 · Received December 23, 2025

    Report

    Report Number
    2124215-2025-92760
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    July 15, 2025
    Report Date
    May 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NAW
    UDI-DI
    05060116920314
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D3, MANUFACTURER ZIP/POSTAL: GU9 8QL. G1, MFR SITE ZIP/POST CODE: GU9 8QL. BASED ON THE NATURE OF THIS PRODUCT, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT-SPECIFIC INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION REPORT BEING SENT TO UPDATE H6: PATIENT CODE. D3, MANUFACTURER ZIP/POSTAL: (B)(6). G1, MFR SITE ZIP/POST CODE: (B)(6). BASED ON THE NATURE OF THIS PRODUCT, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT-SPECIFIC INFORMATION.

    Additional Manufacturer Narrative · 0

    D3, MANUFACTURER ZIP/POSTAL: GU9 8QL. G1, MFR SITE ZIP/POST CODE: GU9 8QL. BASED ON THE NATURE OF THIS PRODUCT, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT-SPECIFIC INFORMATION. INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THAT THE CONTENT WAS SUFFICIENT AND DID NOT CONTRIBUTE TO THE REPORTED EVENT; THEREFORE, NO UPDATES ARE REQUIRED TO THE DOCUMENT AT THIS TIME. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE THERASPHERE DEVICE CONFIRMED THAT THE REPORTED EVENTS ARE KNOWN EVENTS DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRESCRIPTION MEDICATION WAS GIVEN TO TREAT ADVERSE EVENTS. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 0.9%. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER WAS LOBAR (>2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY, AND ONE DOSE VIAL WAS ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS 3.685 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. LUNG DOSE CALCULATION WAS 0.0. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 33 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT WAS DIAGNOSED WITH ASTHENIA, DIFFICULTY IN MOVEMENT, AND SOMNOLENCE. NO ACTION WAS TAKEN TO TREAT THESE EVENTS. ON (B)(6) 2025, 38 DAYS POST THERASPHERE ADMINISTRATION, SUBJECT WAS NOTED WITH EPIGASTRIC PAIN, WHICH WAS MEDICALLY TREATED WITH PANTOPRAZOLE (40 MG/ORAL/DAILY FROM (B)(6) 2025). ON (B)(6) 2025, 43 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT WAS DIAGNOSED WITH DEPRESSED MOOD, CONSTIPATION, HIGH BILIRUBIN, INCREASED TRANSAMINASES, HYPOKALEMIA, AND CHOLESTASIS (CHARACTERIZED BY ELEVATED ALKALINE PHOSPHATASE (ALP) AND GAMMA-GLUTAMYL TRANSFERASE (GGT)). NO ACTION WAS TAKEN TO TREAT THE EVENT OF DEPRESSED MOOD. MEDICATIONS WERE ADMINISTERED TO TREAT THE EVENTS OF HIGH BILIRUBIN, INCREASED TRANSAMINASES, AND CHOLESTASIS. CONSTIPATION WAS MEDICALLY TREATED WITH LACTULOSE (1 TABLESPOON/ORAL/DAILY BEGINNING (B)(6) 2025). HYPOKALEMIA WAS TREATED WITH POTASSIUM CHLORIDE (1200 MICROGRAM/ORAL/DAILY FROM (B)(6) 2025). ON (B)(6) 2025, 71 DAYS POST THERASPHERE ADMINISTRATION, SUBJECT WAS NOTED WITH PERIPHERAL EDEMA AND INCREASED TRANSAMINASES. THE PERIPHERAL EDEMA WAS MEDICALLY TREATED WITH POTASSIUM CANREOATE (100MG/DAILY/ORAL, BEGINNING (B)(6) 2025), AND CONCOMITANT MEDICATION WAS ADMINISTERED AS OTHER ACTION TAKEN TO TREAT THE EVENT OF INCREASED TRANSAMINASES. ON (B)(6) 2025, 127 DAYS POST THERASPHERE ADMINISTRATION, SUBJECT WAS NOTED WITH HIGH BILIRUBIN AND ASCITES. THE ASCITES WAS MEDICALLY TREATED WITH FUROSEMIDE (25 MG/DAILY/ORALLY, FROM (B)(6) 2025), (50 MG/DAILY/ORALLY, FROM (B)(6) 2025), (25 MG/DAILY/ORALLY, FROM (B)(6) 2025) AND (50 MG/DAILY/ORALLY, BEGINNING (B)(6) 2025). NO ACTION WAS TAKEN TO TREAT THE EVENT OF HIGH BILIRUBIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRESCRIPTION MEDICATION WAS GIVEN TO TREAT ADVERSE EVENTS. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 0.9%. ON 1(B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER WAS LOBAR (>2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY, AND ONE DOSE VIAL WAS ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS 3.685 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. LUNG DOSE CALCULATION WAS 0.0. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 33 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT WAS DIAGNOSED WITH ASTHENIA, DIFFICULTY IN MOVEMENT, AND SOMNOLENCE. NO ACTION WAS TAKEN TO TREAT THESE EVENTS. ON (B)(6) 2025, 38 DAYS POST THERASPHERE ADMINISTRATION, SUBJECT WAS NOTED WITH EPIGASTRIC PAIN, WHICH WAS MEDICALLY TREATED WITH PANTOPRAZOLE (40 MG/ORAL/DAILY FROM (B)(6) 2025). ON (B)(6) 2025, 43 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT WAS DIAGNOSED WITH DEPRESSED MOOD, CONSTIPATION, HIGH BILIRUBIN, INCREASED TRANSAMINASES, HYPOKALEMIA, AND CHOLESTASIS (CHARACTERIZED BY ELEVATED ALKALINE PHOSPHATASE (ALP) AND GAMMA-GLUTAMYL TRANSFERASE (GGT)). NO ACTION WAS TAKEN TO TREAT THE EVENT OF DEPRESSED MOOD. MEDICATIONS WERE ADMINISTERED TO TREAT THE EVENTS OF HIGH BILIRUBIN, INCREASED TRANSAMINASES, AND CHOLESTASIS. CONSTIPATION WAS MEDICALLY TREATED WITH LACTULOSE (1 TABLESPOON/ORAL/DAILY BEGINNING (B)(6) 2025). HYPOKALEMIA WAS TREATED WITH POTASSIUM CHLORIDE (1200 MICROGRAM/ORAL/DAILY FROM (B)(6) 2025). ON (B)(6) 2025, 71 DAYS POST THERASPHERE ADMINISTRATION, SUBJECT WAS NOTED WITH PERIPHERAL EDEMA AND INCREASED TRANSAMINASES. THE PERIPHERAL EDEMA WAS MEDICALLY TREATED WITH POTASSIUM CANREOATE (100MG/DAILY/ORAL, BEGINNING (B)(6) 2025), AND CONCOMITANT MEDICATION WAS ADMINISTERED AS OTHER ACTION TAKEN TO TREAT THE EVENT OF INCREASED TRANSAMINASES. ON (B)(6) 2025, 127 DAYS POST THERASPHERE ADMINISTRATION, SUBJECT WAS NOTED WITH HIGH BILIRUBIN AND ASCITES. THE ASCITES WAS MEDICALLY TREATED WITH FUROSEMIDE (25 MG/DAILY/ORALLY, FROM (B)(6) 2025), (50 MG/DAILY/ORALLY, FROM (B)(6) 2025), (25 MG/DAILY/ORALLY, FROM (B)(6) 2025) AND (50 MG/DAILY/ORALLY, BEGINNING (B)(6) 2025). NO ACTION WAS TAKEN TO TREAT THE EVENT OF HIGH BILIRUBIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRESCRIPTION MEDICATION WAS GIVEN TO TREAT ADVERSE EVENTS. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 0.9%. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER WAS LOBAR (>2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY, AND ONE DOSE VIAL WAS ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS 3.685 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. LUNG DOSE CALCULATION WAS 0.0. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 33 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT WAS DIAGNOSED WITH ASTHENIA, DIFFICULTY IN MOVEMENT, AND SOMNOLENCE. NO ACTION WAS TAKEN TO TREAT THESE EVENTS. ON (B)(6) 2025, 38 DAYS POST THERASPHERE ADMINISTRATION, SUBJECT WAS NOTED WITH EPIGASTRIC PAIN, WHICH WAS MEDICALLY TREATED WITH PANTOPRAZOLE (40 MG/ORAL/DAILY FROM 25-JUL-2025 TO 22-AUG-2025). ON (B)(6) 2025, 43 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT WAS DIAGNOSED WITH DEPRESSED MOOD, CONSTIPATION, HIGH BILIRUBIN, INCREASED TRANSAMINASES, HYPOKALEMIA, AND CHOLESTASIS (CHARACTERIZED BY ELEVATED ALKALINE PHOSPHATASE (ALP) AND GAMMA-GLUTAMYL TRANSFERASE (GGT)). NO ACTION WAS TAKEN TO TREAT THE EVENT OF DEPRESSED MOOD. MEDICATIONS WERE ADMINISTERED TO TREAT THE EVENTS OF HIGH BILIRUBIN, INCREASED TRANSAMINASES, AND CHOLESTASIS. CONSTIPATION WAS MEDICALLY TREATED WITH LACTULOSE (1 TABLESPOON/ORAL/DAILY BEGINNING (B)(6) 2025). HYPOKALEMIA WAS TREATED WITH POTASSIUM CHLORIDE (1200 MICROGRAM/ORAL/DAILY FROM (B)(6) 2025 TO (B)(6) 2025). ON (B)(6) 2025, 71 DAYS POST THERASPHERE ADMINISTRATION, SUBJECT WAS NOTED WITH PERIPHERAL EDEMA AND INCREASED TRANSAMINASES. THE PERIPHERAL EDEMA WAS MEDICALLY TREATED WITH POTASSIUM CANREOATE (100MG/DAILY/ORAL, BEGINNING (B)(6) 2025), AND CONCOMITANT MEDICATION WAS ADMINISTERED AS OTHER ACTION TAKEN TO TREAT THE EVENT OF INCREASED TRANSAMINASES. ON (B)(6) 2025, 127 DAYS POST THERASPHERE ADMINISTRATION, SUBJECT WAS NOTED WITH HIGH BILIRUBIN AND ASCITES. THE ASCITES WAS MEDICALLY TREATED WITH FUROSEMIDE (25 MG/DAILY/ORALLY, FROM (B)(6) 2025 TO (B)(6) 2025), (50 MG/DAILY/ORALLY, FROM (B)(6) 2025 TO (B)(6) 2025), (25 MG/DAILY/ORALLY, FROM (B)(6) 2025 TO (B)(6) 2025) AND (50 MG/DAILY/ORALLY, BEGINNING (B)(6) 2025). NO ACTION WAS TAKEN TO TREAT THE EVENT OF HIGH BILIRUBIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442567 THERASPHERE Y-90 (10 GBQ) CE MARK MICROSPHERES RADIONUCLIDE NAW BOSTON SCIENTIFIC CORPORATION 2361-02 2599265 05060116920314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention