BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE

    MDR report key: 15793775 · Received November 14, 2022

    Report

    Report Number
    2124215-2022-46406
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    April 8, 2022
    Report Date
    March 13, 2024
    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

    DATE OF BIRTH: BORN IN 1957. MANUFACTURER ADDRESS 1: (B)(4). MFR SITE ADDRESS 1: (B)(4). MFR SITE ZIP/POST CODE: (B)(4).

    Additional Manufacturer Narrative · 0

    A2: DATE OF BIRTH: BORN IN 1957. 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

    THE PATIENT WAS ENROLLED IN THE PROACTIF CLINICAL STUDY WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR GASTROINTESTINAL BLEEDING. ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. ON (B)(6). 2022, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS RIGHT LIVER (RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII). ON (B)(6). 2022, 50 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED DETERIORATION IN HEALTH. ON (B)(6). 2022, THE SUBJECT WAS ADMITTED IN THE HOSPITAL. THE SUBJECT WAS HOSPITALIZED FOR GASTROINTESTINAL BLEEDING ASSOCIATED TO HEPATIC ENCEPHALOPATHY. ON (B)(6). 2022, FOGD ENDOSCOPY WAS PERFORMED. THE SUBJECT WAS TREATED WITH CONCOMITANT MEDICATION. THE CONCURRENT DISEASE WAS NOTED TO BE CIRRHOSIS, PORTAL HYPERTENSION AND ANTICOAGULATION FOR PORTAL VEIN THROMBOSIS. ON (B)(6). 2022, THE EVENT WAS CONSIDERED TO BE RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY.

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE PROACTIF CLINICAL STUDY WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR GASTROINTESTINAL BLEEDING. ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. ON (B)(6) 2022, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS RIGHT LIVER (RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII). ON (B)(6) 2022, 50 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED DETERIORATION IN HEALTH. ON (B)(6) 2022, THE SUBJECT WAS ADMITTED IN THE HOSPITAL. THE SUBJECT WAS HOSPITALIZED FOR GASTROINTESTINAL BLEEDING ASSOCIATED TO HEPATIC ENCEPHALOPATHY. ON (B)(6) 2022, FOGD ENDOSCOPY WAS PERFORMED. THE SUBJECT WAS TREATED WITH CONCOMITANT MEDICATION. THE CONCURRENT DISEASE WAS NOTED TO BE CIRRHOSIS, PORTAL HYPERTENSION AND ANTICOAGULATION FOR PORTAL VEIN THROMBOSIS. ON (B)(6) 2022, THE EVENT WAS CONSIDERED TO BE RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY. IT WAS FURTHER REPORTED THAT THE THERASPHERE DOSE SIZE WAS 6.715GBQ. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) DOSIMETRY DOCUMENTED THE DOSE TO TOTAL PERFUSED LIVER AS 150 GY. DOSE TO TOTAL PERFUSED TUMOR WAS NOT DETERMINED. TYPE OF THERASPHERE INFUSION WAS RIGHT LIVER. THE CATHETER WAS POSITIONED IN THE RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII); 6.715 GBQ OF THERASPHERE WAS ADMINISTERED TO THE RIGHT LIVER THROUGH VIAL 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2774793 Y-90 THERASPHERE MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R