BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90 (5 GBQ) CE MARK

    MDR report key: 21318090 · Received February 5, 2025

    Report

    Report Number
    2124215-2025-02658
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    December 28, 2024
    Report Date
    April 2, 2025
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    UDI-DI
    05060116920291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 78 YEARS OLD AT THE TIME OF STUDY ENROLLMENT.

    Additional Manufacturer Narrative · 0

    A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 78 YEARS OLD AT THE TIME OF STUDY ENROLLMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE SUBJECT EXPERIENCED THROMBOSIS REQUIRING MEDICATION. THE SUBJECT WAS ENROLLED INTO THE STUDY ON (B)(6) 2024. PRE-TREATMENT MAA (MACROAGGREGATED ALBUMIN) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 5.8%. ON (B)(6) 2024, THE FIRST TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE ADMINISTERED TO THE LIVER WAS MULTIPLE SELECTIVE THROUGH THE RADIAL ARTERY. TWO DOSE VIALS WERE ADMINISTERED. TOTAL ADMINISTERED ACTIVITY DOSE WAS 2.35 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN RANDOM ACTIVITY DISTRIBUTION AND AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. LUNG DOSE CALCULATION WAS 7.6%. ON (B)(6) 2024, THE SECOND TREATMENT WITH THERASPHERE WAS PERFORMED. ONE DOSE VIAL WAS ADMINISTERED. -PRE-TREATMENT MAA IMAGING DOCUMENTED AN AVID UPTAKE IN TARGET LESION, DOSE TO PERFUSED LIVER WAS 400 GY. LUNG SHUNT CALCULATION WAS 9.89%. THERASPHERE ADMINISTERED TO THE LIVER WAS MULTIPLE SELECTIVE THROUGH THE RADIAL ARTERY. TOTAL ADMINISTERED ACTIVITY DOSE WAS 2.21 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN RANDOM ACTIVITY DISTRIBUTION AND AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. DOSE TO PERFUSED LIVER WAS 2635 GY AND DOSE TO TOTAL NORMAL TISSUE WAS 39.6 GY. LUNG DOSE CALCULATION WAS 10.85%. ON (B)(6) 2024, 59 DAYS POST SECOND THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH PORTAL THROMBOSIS. THE THROMBOSIS WAS MANAGED MEDICALLY WITH 60MG OF ENOXAPARIN SODIUM ADMINISTERED SUBCUTANEOUSLY TWICE DAILY, STARTING FROM (B)(6) 2024 AND WAS ONGOING. ON (B)(6) 2024, 61 DAYS POST SECOND THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH INCREASED BILIRUBIN LEVELS. NO ACTION WAS TAKEN TO TREAT THE EVENT. IT WAS FURTHER REPORTED THAT THE THROMBOSIS WAS WITHIN THE LEFT BRANCH OF THE PORTAL VEIN. ON (B)(6) 2024, THE SUBJECT WAS NOTED WITH INCREASED LEVELS OF LDH AND LYMPHOPENIA. NO ACTION WAS TAKEN TO TREAT THE EVENTS. THE LYMPHOPENIA WAS RESOLVED ON (B)(6) 2024. ON (B)(6) 2024, THE SUBJECT WAS NOTED WITH LYMPHOPENIA. NO ACTION WAS TAKEN TO TREAT THE EVENT. THE EVENT WAS RESOLVED ON (B)(6) 2024. ON (B)(6) 2024, THE SUBJECT WAS NOTED WITH LYMPHOPENIA. NO ACTION WAS TAKEN TO TREAT THE EVENT. ON (B)(6) 2025, THE SUBJECT WAS NOTED WITH LYMPHOPENIA. NO ACTION WAS TAKEN TO TREAT THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE SUBJECT EXPERIENCED THROMBOSIS REQUIRING MEDICATION. THE SUBJECT WAS ENROLLED INTO THE STUDY ON (B)(6) 2024. PRE-TREATMENT MAA (MACROAGGREGATED ALBUMIN) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 5.8%. ON (B)(6) 2024, THE FIRST TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE ADMINISTERED TO THE LIVER WAS MULTIPLE SELECTIVE THROUGH THE RADIAL ARTERY. TWO DOSE VIALS WERE ADMINISTERED. TOTAL ADMINISTERED ACTIVITY DOSE WAS 2.35 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN RANDOM ACTIVITY DISTRIBUTION AND AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. LUNG DOSE CALCULATION WAS 7.6%. ON (B)(6) 2024, THE SECOND TREATMENT WITH THERASPHERE WAS PERFORMED. ONE DOSE VIAL WAS ADMINISTERED. -PRE-TREATMENT MAA IMAGING DOCUMENTED AN AVID UPTAKE IN TARGET LESION, DOSE TO PERFUSED LIVER WAS 400 GY. LUNG SHUNT CALCULATION WAS 9.89%. THERASPHERE ADMINISTERED TO THE LIVER WAS MULTIPLE SELECTIVE THROUGH THE RADIAL ARTERY. TOTAL ADMINISTERED ACTIVITY DOSE WAS 2.21 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN RANDOM ACTIVITY DISTRIBUTION AND AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. DOSE TO PERFUSED LIVER WAS 2635 GY AND DOSE TO TOTAL NORMAL TISSUE WAS 39.6 GY. LUNG DOSE CALCULATION WAS 10.85%. ON (B)(6) 2024, 59 DAYS POST SECOND THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH PORTAL THROMBOSIS. THE THROMBOSIS WAS MANAGED MEDICALLY WITH 60MG OF ENOXAPARIN SODIUM ADMINISTERED SUBCUTANEOUSLY TWICE DAILY, STARTING FROM (B)(6) 2024 AND WAS ONGOING. ON (B)(6) 2024, 61 DAYS POST SECOND THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH INCREASED BILIRUBIN LEVELS. NO ACTION WAS TAKEN TO TREAT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311308 THERASPHERE Y-90 (5 GBQ) CE MARK MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2361-02 05060116920291

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention