BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90

    MDR report key: 21644567 · Received March 19, 2025

    Report

    Report Number
    2124215-2025-13416
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    September 11, 2024
    Report Date
    May 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE STUDY DID NOT PROVIDE THE DOSE SIZE OR UPN; THUS, THE UDI IS UNABLE TO BE POPULATED. D3, MANUFACTURER ZIP/POSTAL: (B)(6), G1, MFR SITE ZIP/POST CODE: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD SYMPTOMS THAT WERE TREATED WITH PRESCRIPTION MEDICATION. ON (B)(6)2024, THE SUBJECT WAS RANDOMIZED (THERMOSPHERE ARM) IN THE CLINICAL STUDY (MAIN PHASE) WITH THE PLANNED TREATMENT TYPE WAS UNI-LOBAR TREATMENT. TREATMENT WITH THERMOSPHERE WAS PERFORMED ON (B)(6) 2024; 99MTC-MAA ANGIOGRAM WAS PERFORMED, AND TARGET VOLUME WAS 624 CM3 AND 14.73 GBQ WAS ADMINISTERED THROUGH 1 VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.17 GBQ. RADIATION DOSE TO PERFUSED LIVER TISSUE, AND DOSE TO PERFUSED TARGET TUMOR TISSUE WAS DETAILS WERE NOT AVAILABLE AT THE TIME OF REPORTING. A RE-TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6)2024 WITH THE PLANNED TREATMENT TYPE WAS SELECTIVE TREATMENT. TARGET VOLUME WAS 177.94 CM3 AND 5.96 GBQ WAS ADMINISTERED THROUGH 1 VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.183 GBQ AND TOTAL ACTIVITY OF THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE 2.167 GBQ. RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 593 GY AND RADIATION DOSE TO LUNGS WAS 9.1GY. ON (B)(6)2024, 145 DAYS POST INDEX PROCEDURE, SUBJECT EXPERIENCED MALAISE, ANOREXIA, AND NAUSEA. NO CORRECTIVE ACTION WAS TAKEN TO TREAT THE EVENT OF MALAISE; HOWEVER, MEGESTROL ACETATE DISPERSIBLE TABLETS WERE ADMINISTERED TO TREAT ANOREXIA AND BOTH ONDANSETRON HYDROCHLORIDE TABLETS AND ESOMEPRAZOLE MAGNESIUM ENTERIC-COATED TABLETS WERE ADMINISTERED TO TREAT NAUSEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484336 THERASPHERE Y-90 MICROSPHERES RADIONUCLIDE NAW BOSTON SCIENTIFIC CORPORATION 2499175

    Patients

    Seq Age Sex Outcome Treatment
    1