BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90 (9 GBQ) CN CLINICAL

    MDR report key: 21690195 · Received March 25, 2025

    Report

    Report Number
    2124215-2025-18166
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    February 19, 2025
    Report Date
    October 28, 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

    A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 49 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. A4 - WEIGHT: 49.5 KG D3 - MANUFACTURER ZIP/POSTAL CODE: GU9 8QL G2 - MFR SITE ZIP/POST CODE: GU9 8QL.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B5 - DESCRIBE EVENT OR PROBLEM: BASED ON ADDITIONAL INFORMATION RECEIVED BY BOSTON SCIENTIFIC ON (B)(6) 2025, THERE IS NO LONGER ANY ALLEGATION THAT THE THROMBOCYTOPENIA IS RELATED TO THE THERASPHERE DEVICE OR PROCEDURE. H6 - PATIENT CODES, IMPACT CODES, DEVICE CODES, EVALUATION CONCLUSION CODES. BASED ON THE NATURE OF THIS PRODUCT, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) AND OTHER PRODUCT SPECIFIC INFORMATION. A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 49 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3 - MANUFACTURER ZIP/POSTAL CODE: (B)(6). G2 - MFR SITE ZIP/POST CODE: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT EXPERIENCED A DECREASED PLATELET COUNT REQUIRING MEDICATION. ON 18-JUL-2023, THE SUBJECT WAS RANDOMIZED IN THE STUDY. TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2023. 99MTC-MAA ANGIOGRAM WAS PERFORMED AND TARGET VOLUME 420 CM3. 2.99 GBQ WAS ADMINISTERED THROUGH VIAL 1. 8.71 GBQ WAS ADMINISTERED THROUGH VIAL 2. TOTAL DOSE ADMINISTERED WAS 11. 7 GBQ. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS REPORTED AS 0.26 GBQ AND THERASPHERE DELIVERY TO TARGET TUMOR TISSUE WAS 341 GY. TOTAL RADIATION DOSE TO THE PERFUSED NORMAL LIVER TISSUE WAS 111.7 GY AND RADIATION DOSE TO LUNGS WAS 12.8 GY. ON (B)(6) 2025, 572 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED DECREASED PLATELET COUNT. AVATROMBOPAG MALEATE TABLETS WERE GIVEN TO TREAT THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT EXPERIENCED A DECREASED PLATELET COUNT REQUIRING MEDICATION. ON (B)(6) 2023, THE SUBJECT WAS RANDOMIZED IN THE STUDY. TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2023. 99MTC-MAA ANGIOGRAM WAS PERFORMED AND TARGET VOLUME 420 CM3. 2.99 GBQ WAS ADMINISTERED THROUGH VIAL 1. 8.71 GBQ WAS ADMINISTERED THROUGH VIAL 2. TOTAL DOSE ADMINISTERED WAS 11. 7 GBQ. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS REPORTED AS 0.26 GBQ AND THERASPHERE DELIVERY TO TARGET TUMOR TISSUE WAS 341 GY. TOTAL RADIATION DOSE TO THE PERFUSED NORMAL LIVER TISSUE WAS 111.7 GY AND RADIATION DOSE TO LUNGS WAS 12.8 GY. ON (B)(6) 2025, 572 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED DECREASED PLATELET COUNT. AVATROMBOPAG MALEATE TABLETS WERE GIVEN TO TREAT THE EVENT. NO FURTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THE DECREASED PLATELET COUNT WAS NOT RELATED TO THE THERASPHERE DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804529 THERASPHERE Y-90 (9 GBQ) CN CLINICAL MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2361-01 2399340

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention