BEUDAMED
    FDA Adverse Event Death Summary report: N

    Y-90 THERASPHERE (3 GBQ) CANADA COMM

    MDR report key: 13023495 · Received December 16, 2021

    Report

    Report Number
    2134265-2021-15945
    Event Type
    Death
    Date Received
    December 16, 2021
    Date of Event
    November 8, 2021
    Report Date
    December 16, 2021
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS 1: (B)(6).

    Description of Event or Problem · 0

    PROACTIF STUDY. IT WAS REPORTED THAT DUODENAL ULCERATION AND DEATH OCCURRED. IN (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. IT WAS NOTED THAT ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS THE TREATMENT DOSE. PRE-TREATMENT DOSIMETRY DOCUMENTED A STRONG UPTAKE OF Y90 ON TUMORS, DOSE TO PERFUSED LIVER WAS 362.7 GY AND DOSE TO PERFUSED TUMOR WAS 491.7 GY. 7.468 GBQ OF THERASPHERE WAS ADMINISTERED TO THE RIGHT LIVER THROUGH VIAL 1 (ULTRASELECTIVE). THE TYPE OF THERASPHERE INFUSION WAS NOT DOCUMENTED. POST-TREATMENT DOSIMETRY DOCUMENTED A STRONG UPTAKE OF Y90 ON TUMORS, DOSE TO PERFUSED LIVER WAS 185 GY AND DOSE TO PERFUSED TUMOR WAS 371 GY. IN (B)(6) 2021, THE SUBJECT SUFFERED FROM DUODENAL ULCERATION POST SELECTIVE INTERNAL RADIATION THERAPY (SIRT). HEPATECTOMY WAS PERFORMED. THREE DAYS POST SURGERY THE SUBJECT SUFFERED SEPTIC SHOCK. PERITONEAL WASH WAS PERFORMED. ON THE SAME DAY, THE SUBJECT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921491 Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Death