BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE Y-90 GLASS MICROSPHERES

    MDR report key: 17655558 · Received August 30, 2023

    Report

    Report Number
    2124215-2023-46592
    Event Type
    Death
    Date Received
    August 30, 2023
    Date of Event
    July 20, 2023
    Report Date
    April 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

    D3: MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK, D3; MANUFACTURER STATE: ON, D3: MANUFACTURER ZIP/POSTAL CODE: GU9 8QL, G1: MFR SITE ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK, G1: MFR SITE STATE: ON, G1: MFR SITE ZIP/POST CODE: GU9 8QL.

    Additional Manufacturer Narrative · 0

    D3: MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. D3: MANUFACTURER ZIP/POSTAL CODE: GU9 8QL. G1: MFR SITE ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. G1: MFR SITE ZIP/POST CODE: GU9 8QL.

    Additional Manufacturer Narrative · 0

    (B)(6). BASED ON THE NATURE OF THE PRODUCT, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    MANDARIN STUDY: IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEPATIC INSUFFICIENCY POST-THERASPHERE TREATMENT. ON (B)(6) 2023, THE SUBJECT WAS ENROLLED INTO MANDARIN STUDY (RUN-IN PHASE), WHERE THE PLANNED TREATMENT TYPE WAS SELECTIVE TREATMENT. TREATMENT WITH THERASPHERE 12.5 GBQ WAS ADMINISTERED THROUGH VIAL 1 ON (B)(6) 2023. THE 99MTC-MAA ANGIOGRAM WAS PERFORMED AND TARGET VOLUME WAS 234 CM3. ON (B)(6) 2023, THE SUBJECT WAS DIAGNOSED WITH HEPATIC INSUFFICIENCY (SEVERE, 3 GRADE) AND LAB DATA REVEALED INCREASED ASPARTATE AMINOTRANSFERASE (MILD, GRADE 1). IT WAS INDICATED THAT THE HEPATIC INSUFFICIENCY WAS TREATED MEDICALLY. THE CONCOMITANT ORAL MEDICATIONS THAT THE PATIENT WAS TAKING INCLUDED 456 MG POLYENE PHOSPHATIDYLCHOLINE CAPSULES AND 150 MG DIAMMONIUM GLYCYRRHIZINATE ENTERIC-COATED CAPSULES.

    Description of Event or Problem · 0

    (B)(6) STUDY: IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEPATIC INSUFFICIENCY POST-THERASPHERE TREATMENT. ON (B)(6) 2023, THE SUBJECT WAS ENROLLED INTO (B)(6) STUDY (RUN-IN PHASE), WHERE THE PLANNED TREATMENT TYPE WAS SELECTIVE TREATMENT. TREATMENT WITH THERASPHERE 12.5 GBQ WAS ADMINISTERED THROUGH VIAL 1 ON (B)(6) 2023. THE 99MTC-MAA ANGIOGRAM WAS PERFORMED AND TARGET VOLUME WAS 234 CM3. ON (B)(6) 2023, 90 DAYS POST-INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH HEPATIC INSUFFICIENCY (SEVERE, 3 GRADE) AND LAB DATA REVEALED INCREASED ASPARTATE AMINOTRANSFERASE (MILD, GRADE 1). IT WAS INDICATED THAT THE HEPATIC INSUFFICIENCY WAS TREATED MEDICALLY. THE CONCOMITANT ORAL MEDICATIONS THAT THE PATIENT WAS TAKING INCLUDED 456 MG POLYENE PHOSPHATIDYLCHOLINE CAPSULES AND 150 MG DIAMMONIUM GLYCYRRHIZINATE ENTERIC-COATED CAPSULES. ADDITIONAL INFORMATION WAS RECEIVED THAT ON 20-JULY-2023, ONE DAY PRIOR TO THE DIAGNOSIS OF HEPATIC INSUFFICIENCY, THE SUBJECT WAS DIAGNOSED WITH CIRRHOSIS (MILD, GRADE 1). NO ACTION WAS TAKEN TO TREAT THE EVENT. FURTHER INFORMATION WAS REPORTED THAT ON (B)(6) 2023, THE SUBJECT PASSED AWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEPATIC INSUFFICIENCY POST-THERASPHERE TREATMENT. ON (B)(6) 2023, THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY (RUN-IN PHASE), WHERE THE PLANNED TREATMENT TYPE WAS SELECTIVE TREATMENT. TREATMENT WITH THERASPHERE 12.5 GBQ WAS ADMINISTERED THROUGH VIAL 1 ON (B)(6) 2023. THE 99MTC-MAA ANGIOGRAM WAS PERFORMED AND TARGET VOLUME WAS 234 CM3. ON (B)(6) 2023, 90 DAYS POST-INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH HEPATIC INSUFFICIENCY (SEVERE, 3 GRADE) AND LAB DATA REVEALED INCREASED ASPARTATE AMINOTRANSFERASE (MILD, GRADE 1). IT WAS INDICATED THAT THE HEPATIC INSUFFICIENCY WAS TREATED MEDICALLY. THE CONCOMITANT ORAL MEDICATIONS THAT THE PATIENT WAS TAKING INCLUDED 456 MG POLYENE PHOSPHATIDYLCHOLINE CAPSULES AND 150 MG DIAMMONIUM GLYCYRRHIZINATE ENTERIC-COATED CAPSULES. ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6) 2023, ONE DAY PRIOR TO THE DIAGNOSIS OF HEPATIC INSUFFICIENCY, THE SUBJECT WAS DIAGNOSED WITH CIRRHOSIS (MILD, GRADE 1). NO ACTION WAS TAKEN TO TREAT THE EVENT. FURTHER INFORMATION WAS REPORTED THAT ON (B)(6) 2023, THE SUBJECT PASSED AWAY. ADDITIONAL PROCEDURE DETAILS WERE PROVIDED THAT THE TOTAL ACTIVITY THAT WAS DELIVERED AT TIME OF TREATMENT WAS 2.84 GBQ AND TOTAL ACTIVITY TO PERFUSED LIVER TISSUE WAS 2.2 GBQ. THE TOTAL ACTIVITY TO LUNGS WAS 0.635 GBQ, THE RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 425 GY, TOTAL RADIATION DOSE TO LUNGS WAS 31.8 GY AND CUMULATIVE RADIATION TO LUNGS WAS 31.8 GY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287072 THERASPHERE Y-90 GLASS MICROSPHERES MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2361-01

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| D