BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90 (10 GBQ) CN CLINICAL

    MDR report key: 18292004 · Received December 8, 2023

    Report

    Report Number
    2124215-2023-68509
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    September 12, 2023
    Report Date
    January 16, 2024
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1 - PATIENT IDENTIFIER: (B)(6). A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 69 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3 & G1 - MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK; D3 & G1 - MANUFACTURER ZIP/POSTAL CODE: GU9 8QL.

    Additional Manufacturer Narrative · 0

    A1 - PATIENT IDENTIFIER: (B)(6). A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 69 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3 & G1 - MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. D3 & G1 - MANUFACTURER ZIP/POSTAL CODE: GU9 8QL. H6 - PATIENT CODES: E2402 USED TO DESCRIBE REPORTED EVENT OF POST-INTERVENTIONAL EMBOLIZATION SYNDROME.

    Description of Event or Problem · 0

    MANDARIN. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED ELEVATED GLUTAMYL TRANSPEPTIDASE, INTERVENTIONAL EMBOLIZATION SYNDROME, AND A URINARY TRACT INFECTION FOLLOWING THE INDEX PROCEDURE. ON (B)(6) 2023, THE SUBJECT WAS RANDOMIZED (THERASPHERE ARM) IN THE MANDARIN STUDY (MAIN PHASE). PLANNED TREATMENT TYPE WAS UNI-LOBAR TREATMENT. TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2023. 99MTC-MAA ANGIOGRAM WAS PERFORMED AND TARGET VOLUME WAS 66.46 CM3. 10 GBQ WAS ADMINISTERED THROUGH ONE VIAL. ON (B)(6) 2023, 28 DAYS POST INDEX PROCEDURE, LAB RESULTS REVEALED ELEVATED GLUTAMYL TRANSPEPTIDASE (GGT). NCI-CTCAE V5.0 GRADE- 1 (MILD). INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN TO TREAT THE EVENT IS CURRENTLY UNAVAILABLE. AT THE TIME OF REPORTING, OUTCOME OF THE EVENT WAS CONSIDERED NOT RESOLVED. ON (B)(6) 2023, 34 DAYS POST INDEX PROCEDURE, SUBJECT WAS DIAGNOSED TO HAVE POST-INTERVENTIONAL EMBOLIZATION SYNDROME. NCI-CTCAE V5.0 GRADE- 1 (MILD). METOCLOPRAMIDE HYDROCHLORIDE INJECTION WAS GIVEN. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED. ON (B)(6) 2023, 35 DAYS POST INDEX PROCEDURE, SUBJECT WAS DIAGNOSED TO HAVE URINARY TRACT INFECTION. NCI-CTCAE V5.0 GRADE- 2 (MODERATE). LEVOFLOXACIN TABLETS WERE GIVEN AS A CORRECTIVE ACTION TO TREAT THE EVENT. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT THE PREVIOUSLY REPORTED EVENTS OF POST-INTERVENTIONAL EMBOLIZATION SYNDROME AND URINARY TRACT INFECTION ARE NO LONGER ALLEGED AS HAVING BEEN THE RESULT OF THE THERASPHERE DEVICE OR THE INDEX PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT EXPERIENCED ELEVATED GLUTAMYL TRANSPEPTIDASE, INTERVENTIONAL EMBOLIZATION SYNDROME, AND A URINARY TRACT INFECTION FOLLOWING THE INDEX PROCEDURE. ON (B)(6) 2023, THE SUBJECT WAS RANDOMIZED (THERASPHERE ARM) IN THE MANDARIN STUDY (MAIN PHASE). PLANNED TREATMENT TYPE WAS UNI-LOBAR TREATMENT. TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2023. 99MTC-MAA ANGIOGRAM WAS PERFORMED AND TARGET VOLUME WAS 66.46 CM3. 10 GBQ WAS ADMINISTERED THROUGH ONE VIAL. ON 12-SEP-2023, 28 DAYS POST INDEX PROCEDURE, LAB RESULTS REVEALED ELEVATED GLUTAMYL TRANSPEPTIDASE (GGT). NCI-CTCAE V5.0 GRADE- 1 (MILD). INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN TO TREAT THE EVENT IS CURRENTLY UNAVAILABLE. AT THE TIME OF REPORTING, OUTCOME OF THE EVENT WAS CONSIDERED NOT RESOLVED. ON (B)(6) 2023, 34 DAYS POST INDEX PROCEDURE, SUBJECT WAS DIAGNOSED TO HAVE POST-INTERVENTIONAL EMBOLIZATION SYNDROME. NCI-CTCAE V5.0 GRADE- 1 (MILD). METOCLOPRAMIDE HYDROCHLORIDE INJECTION WAS GIVEN. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED. ON (B)(6) 2023, 35 DAYS POST INDEX PROCEDURE, SUBJECT WAS DIAGNOSED TO HAVE URINARY TRACT INFECTION. NCI-CTCAE V5.0 GRADE- 2 (MODERATE). LEVOFLOXACIN TABLETS WERE GIVEN AS A CORRECTIVE ACTION TO TREAT THE EVENT. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876928 THERASPHERE Y-90 (10 GBQ) CN CLINICAL MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2361-01 2399370

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention