BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE Y-90

    MDR report key: 21734767 · Received March 31, 2025

    Report

    Report Number
    2124215-2025-19639
    Event Type
    Death
    Date Received
    March 31, 2025
    Date of Event
    January 20, 2022
    Report Date
    May 6, 2025
    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

    D3 & G1: MANUFACTURER ZIP/POSTAL CODE: (B)(6). E1 INITIAL REPORTER ADDRESS 1: (B)(6). THE UPN AND LOT NUMBERS WERE NOT PROVIDED BY THE STUDY; THUS, THE UDI AND OTHER PRODUCT SPECIFIC INFORMATION IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    D3 & G1: MANUFACTURER ZIP/POSTAL CODE: GU9 8QL. E1 INITIAL REPORTER ADDRESS 1: (B)(6). THE UPN AND LOT NUMBERS WERE NOT PROVIDED BY THE STUDY; THUS, THE UDI AND OTHER PRODUCT SPECIFIC INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT PASSED AWAY RELATED TO OEDEMA DECOMPENSATION. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO THE STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY TO THE SELECTIVE LIVER. THE CATHETER POSITIONING DURING THE ADMINISTRATION PROCEDURE WAS NOT DOCUMENTED. TWO VIALS WERE ADMINISTERED TO THE PATIENT; 4.72 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 1 AND 4.56 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 2. TOTAL THERASPHERE ACTIVITY ADMINISTERED TO THE SELECTIVE LIVER WAS 9.28 GBQ. ON (B)(6) 2022, 223 DAYS POST-INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH OEDEMA DECOMPENSATION. ON THE SAME DAY, THE SUBJECT WAS ADMITTED TO EMERGENCY ROOM DUE TO ALTERATION OF THEIR GENERAL CONDITION. DURING THE HOSPITALIZATION ASCITES WITH SIGNIFICANT LOWER LIMB EDEMA WAS DIAGNOSED, THUS DIURETICS WERE ADMINISTERED, AND REGULAR ASCITES PUNCTURE WAS PERFORMED TO TREAT THE EVENT. ADDITIONALLY, MAINTENANCE OF DIURETICS WAS ALSO PRESCRIBED. ON (B)(6) 2022, THE OUTCOME OF THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY. POST-DISCHARGE, THE SUBJECT HAS HAD PERSISTENT ASCITES OF GREAT ABUNDANCE (ECOG, 2), WHICH WAS TREATED WITH REPEATED PUNCTURE. ON (B)(6) 2022, THE SUBJECT PASSED AWAY DUE TO PROGRESSION OF LIVER DISEASE AND NOT DUE TO THE PROGRESSION OF THEIR CANCER, WHERE THEIR HEPATOPATHY WAS DECOMPENSATED AS A RESULT OF RADIO-EMBOLIZATION. FOLLOW-UP INFORMATION WAS PROVIDED WITH ADDITIONAL DETAILS THAT OCCURRED BETWEEN (B)(6) 2022 AND WHEN THE PATIENT PASSED AWAY. THE PATIENT WAS SEEN AT A FOLLOW-UP VISIT ON (B)(6) 2021 DUE TO FATIGUE. FROM (B)(6) 2022, THE PATIENT WAS OBSERVED FOR DYSPNEA AND FATIGUE, WHERE THE EXPLORATION CONCLUDED LIVER DECOMPENSATION WITH ASCITES AND OEDEMA, HYPOALBUMINEMIA 25G/L (BUT NORMAL BILIRUBIN). THE CT SCAN DID NOT IDENTIFY A TUMOR BUT SIRT SEQUELAE, ASCITES, LARGE PELVIC AND ABDOMINAL VEIN, AND LARGE UMBILICAL VEIN. PATIENT WAS DISCHARGED WITH "DIURETICS" ON (B)(6) 2020 (AS PREVIOUSLY REPORTED). ON (B)(6) 2022 A FOLLOW-UP PROVIDED THE PATIENT HAD DETERIORATED, ECOG2, NO CLINICAL ASCITES, LOWER LIMB OEDEMA. ON (B)(6) 2022 A CT SCAN DID NOT IDENTIFY A TUMOR BUT SIRT SEQUELAE AND ASCITES. THE PATIENT UNDERSTOOD THAT WITH THEIR LIVER FUNCTION DETERIORATION NO MORE TREATMENT WAS PROPOSED AND WAS PLACED ON IN-HOME SUPPORTIVE CARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT PASSED AWAY RELATED TO OEDEMA DECOMPENSATION. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO THE STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY TO THE SELECTIVE LIVER. THE CATHETER POSITIONING DURING THE ADMINISTRATION PROCEDURE WAS NOT DOCUMENTED. TWO VIALS WERE ADMINISTERED TO THE PATIENT; 4.72 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 1 AND 4.56 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 2. TOTAL THERASPHERE ACTIVITY ADMINISTERED TO THE SELECTIVE LIVER WAS 9.28 GBQ. ON (B)(6) 2022, 223 DAYS POST-INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH OEDEMA DECOMPENSATION. ON THE SAME DAY, THE SUBJECT WAS ADMITTED TO EMERGENCY ROOM DUE TO ALTERATION OF THEIR GENERAL CONDITION. DURING THE HOSPITALIZATION ASCITES WITH SIGNIFICANT LOWER LIMB EDEMA WAS DIAGNOSED, THUS DIURETICS WERE ADMINISTERED, AND REGULAR ASCITES PUNCTURE WAS PERFORMED TO TREAT THE EVENT. ADDITIONALLY, MAINTENANCE OF DIURETICS WAS ALSO PRESCRIBED. ON (B)(6) 2022, THE OUTCOME OF THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY. POST-DISCHARGE, THE SUBJECT HAS HAD PERSISTENT ASCITES OF GREAT ABUNDANCE (ECOG, 2), WHICH WAS TREATED WITH REPEATED PUNCTURE. ON (B)(6) 2022, THE SUBJECT PASSED AWAY DUE TO PROGRESSION OF LIVER DISEASE AND NOT DUE TO THE PROGRESSION OF THEIR CANCER, WHERE THEIR HEPATOPATHY WAS DECOMPENSATED AS A RESULT OF RADIO-EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912562 THERASPHERE Y-90 MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death| H| R