BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE

    MDR report key: 17829748 · Received September 27, 2023

    Report

    Report Number
    2124215-2023-52977
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    April 14, 2023
    Report Date
    November 22, 2023
    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

    A2: AGE AT TIME OF EVENT: 68 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3: MANUFACTURER ADDRESS 1: (B)(6); G1: MFR SITE ADDRESS 1: (B)(6); G1: MFR SITE ZIP/POST CODE: (B)(6).

    Additional Manufacturer Narrative · 0

    A2: AGE AT TIME OF EVENT: 68 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. B3: DATE OF EVENT WAS ESTIMATED USING DATE SECONDARY SYMPTOMS WERE OBSERVED. D3: MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. G1: MFR SITE ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. G1: MFR SITE ZIP/POST CODE: GU9 8QL.

    Description of Event or Problem · 0

    PROACTIF CLINICAL STUDY: IT WAS REPORTED THAT THE PATIENT EXPERIENCED LIVER DYSFUNCTION. ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS THE TREATMENT DOSE. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) DOSIMETRY DOCUMENTED DOSE TO TOTAL PERFUSED LIVER AS 203 GY AND DOSE TO TOTAL PERFUSED TUMOR WAS 350.6 GY. ON (B)(6) 2023, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION FOR VIAL 1 WAS RIGHT LIVER. THE CATHETER WAS POSITIONED IN THE RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII): 5.558 GBQ OF THERASPHERE WAS ADMINISTERED TO THE RIGHT LIVER THROUGH VIAL 1. IN (B)(6) 2023, THE SUBJECT EXPERIENCED AN ALTERATION IN THEIR GENERAL HEALTH CONDITION. ON (B)(6) 2023, 43 DAYS POST INDEX PROCEDURE, DURING THE CONSULTATION, THE SUBJECT WAS NOTED WITH ANOREXIA, WEIGHT LOSS, AND ABDOMINAL PAIN ASSOCIATED WITH ALTERED GENERAL CONDITION. ON THE SAME DAY, ENCEPHALOPATHY SCORE WAS ASSESSED AS GRADE 1. ADDITIONALLY, LABORATORY RESULTS REVEALED 68 MICROMOL/L OF BILIRUBIN, ASAT (ASPARTATE AMINOTRANSFERASE) SCORE WAS ASSESSED AS 2.5N, AND TP (TOTAL PROTEIN) HAD BEEN ASSESSED AS NORMAL. ON (B)(6) 2023, CT SCAN WAS PERFORMED, WHICH REVEALED THE PARTIAL RESPONSE. ON (B)(6) 2023, 49 DAYS POST INDEX PROCEDURE, SUBJECT WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION. ON (B)(6) 2023, REPEAT BILIRUBIN VALUE WAS ASSESSED AS 52 MICROMOLE/LITER. ADDITIONALLY, THE SUBJECT WAS NOTED WITH DEPRESSIVE SYNDROME. 10 MG OF OXAZEPAM 3 TIMES PER DAY AND 125 ML FORTIMEL PROTEIN WERE ADMINISTRATED. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. THE EVENT WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, A CT SCAN REVEALED THE PARTIAL REGRESSION OF HEPATIC DOME LESION, A LAYER OF ASCITES, PERSISTENT RIGHT POSTERIOR PORTAL THROMBOSIS, AND PERFUSION DISORDERS IN THE RIGHT LATERAL SECTOR.

    Description of Event or Problem · 0

    PROACTIF CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LIVER DYSFUNCTION. ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS THE TREATMENT DOSE. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) DOSIMETRY DOCUMENTED DOSE TO TOTAL PERFUSED LIVER AS 203 GY AND DOSE TO TOTAL PERFUSED TUMOR WAS 350.6 GY. ON (B)(6) 2023, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION FOR VIAL 1 WAS RIGHT LIVER. THE CATHETER WAS POSITIONED IN THE RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII): 5.558 GBQ OF THERASPHERE WAS ADMINISTERED TO THE RIGHT LIVER THROUGH VIAL 1. IN (B)(6) 2023, THE SUBJECT EXPERIENCED AN ALTERATION IN THEIR GENERAL HEALTH CONDITION. ON (B)(6) 2023, 43 DAYS POST INDEX PROCEDURE, DURING THE CONSULTATION, THE SUBJECT WAS NOTED WITH ANOREXIA, WEIGHT LOSS, AND ABDOMINAL PAIN ASSOCIATED WITH ALTERED GENERAL CONDITION. ON THE SAME DAY, ENCEPHALOPATHY SCORE WAS ASSESSED AS GRADE 1. ADDITIONALLY, LABORATORY RESULTS REVEALED 68 MICROMOL/L OF BILIRUBIN, ASAT (ASPARTATE AMINOTRANSFERASE) SCORE WAS ASSESSED AS 2.5N, AND TP (TOTAL PROTEIN) HAD BEEN ASSESSED AS NORMAL. ON (B)(6) 2023, CT SCAN WAS PERFORMED, WHICH REVEALED THE PARTIAL RESPONSE. ON (B)(6) 2023, 49 DAYS POST INDEX PROCEDURE, SUBJECT WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION. ON (B)(6) 2023, REPEAT BILIRUBIN VALUE WAS ASSESSED AS 52 MICROMOLE/LITER. ADDITIONALLY, THE SUBJECT WAS NOTED WITH DEPRESSIVE SYNDROME. 10 MG OF OXAZEPAM 3 TIMES PER DAY AND 125 ML FORTIMEL PROTEIN WERE ADMINISTRATED. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. THE EVENT WAS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286682 Y-90 THERASPHERE MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization