BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90 (3 GBQ) CN CLINICAL

    MDR report key: 21997581 · Received May 9, 2025

    Report

    Report Number
    2124215-2025-29852
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    September 28, 2023
    Report Date
    September 9, 2025
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    UDI-DI
    05060116922080
    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 69 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3 - MANUFACTURER ZIP/POSTAL: GU9 8QL G1 - MFR SITE ZIP/POST CODE: GU9 8QL H6 - PATIENT CODE(S): E2402 WAS USED TO CAPTURE THE REPORTED PATIENT SYMPTOM OF POST EMBOLIZATION SYNDROME (PES). 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.

    Additional Manufacturer Narrative · 0

    A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 69 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3 - MANUFACTURER ZIP/POSTAL: (B)(6). G1 - MFR SITE ZIP/POST CODE: (B)(6). H6 - PATIENT CODE(S): E2402 WAS USED TO CAPTURE THE REPORTED PATIENT SYMPTOM OF POST EMBOLIZATION SYNDROME (PES). 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

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT HAD POST-INTERVENTIONAL EMBOLIZATION SYNDROME. ON (B)(6) 2023, THE SUBJECT WAS RANDOMIZED INTO A CLINICAL TRIAL. THERASPHERE TREATMENT WAS PERFORMED ON (B)(6) 2023. RE-TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2023. PLANNED TREATMENT TYPE WAS SELECTIVE TREATMENT. TARGET VOLUME WAS 119.6 CM3. 2.99 GBQ WAS ADMINISTERED THROUGH ONE VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.131 GBQ AND TOTAL ACTIVITY OF THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE WAS 1.09 GBQ. RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 442 GY AND RADIATION DOSE TO LUNGS WAS 6.5 GY. ON (B)(6) 2023, ON THE SAME OF RE-TREATMENT WITH THERASPHERE, THE SUBJECT WAS DIAGNOSED WITH POST-INTERVENTIONAL EMBOLIZATION SYNDROME WITH SYMPTOMS OF ABDOMINAL PAIN AND NAUSEA. MEDICATION WAS ADMINISTERED AS A CORRECTIVE ACTION TO TREAT THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT HAD POST-INTERVENTIONAL EMBOLIZATION SYNDROME. ON (B)(6) 2023, THE SUBJECT WAS RANDOMIZED INTO A CLINICAL TRIAL. THERASPHERE TREATMENT WAS PERFORMED ON (B)(6) 2023. RE-TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2023. PLANNED TREATMENT TYPE WAS SELECTIVE TREATMENT. TARGET VOLUME WAS 119.6 CM3. 2.99 GBQ WAS ADMINISTERED THROUGH ONE VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.131 GBQ AND TOTAL ACTIVITY OF THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE WAS 1.09 GBQ. RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 442 GY AND RADIATION DOSE TO LUNGS WAS 6.5 GY. ON (B)(6) 2023, ON THE SAME OF RE-TREATMENT WITH THERASPHERE, THE SUBJECT WAS DIAGNOSED WITH POST-INTERVENTIONAL EMBOLIZATION SYNDROME WITH SYMPTOMS OF ABDOMINAL PAIN AND NAUSEA. MEDICATION WAS ADMINISTERED AS A CORRECTIVE ACTION TO TREAT THE EVENT. IT WAS FURTHER REPORTED THAT THE SUBJECT WAS TREATED WITH ELETROSTATIC THERAPY (INTRAOCULAR) ON (B)(6) 2023. THE PREVIOUS REPORT OF MEDICATION TO TREAT THE EVENT WAS RETRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131015 THERASPHERE Y-90 (3 GBQ) CN CLINICAL MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2361-01 2399448 05060116922080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention