BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90 (6.5 GBQ) CE MARK

    MDR report key: 19005376 · Received March 29, 2024

    Report

    Report Number
    2124215-2024-18347
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    December 15, 2023
    Report Date
    April 9, 2024
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    UDI-DI
    05060116920390
    PMA / PMN Number
    H980006
    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: THE SUBJECT WAS 66 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3 & G1 - MANUFACTURER ADDRESS 1: (B)(6).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4. A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 66 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3 & G1 - MANUFACTURER ADDRESS 1: (B)(6). D3 & G1 - MANUFACTURER ZIP/POSTAL CODE: (B)(6).

    Description of Event or Problem · 0

    PROACTIF CLINICAL STUDY IT WAS REPORTED THAT THE SUBJECT EXPERIENCED EDEMATO-ASCITIC DECOMPENSATION 114 DAYS POST INDEX PROCEDURE. THE SUBJECT WAS HOSPITALIZED, AND INTERVENTION WAS PERFORMED AS A RESULT. PRIOR TO THE INDEX PROCEDURE, ADVANCED MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT DOSIMETRY DOCUMENTED, DOSE TO TOTAL PERFUSED LIVER WAS 614 GY AND DOSE TO TOTAL PERFUSED TUMOR WAS 800 GY. ON (B)(6) 2023, THE SUBJECT WAS ENROLLED INTO THE PROACTIF CLINICAL STUDY AND THE TREATMENT WITH THERASPHERE Y-90 GLASS MICROSPHERES WAS PERFORMED ON THE SAME DAY. THE TYPE OF THERASPHERE INFUSION WAS SELECTIVE. 3.143 GBQ OF THERASPHERE WAS ADMINISTERED TO THE LEFT MEDIAN SECTOR (SEGMENT IV). POST TREATMENT DOSIMETRY DOCUMENTED THE UPTAKE OF THE DELIVERED DOSE TO PERFUSED LIVER WAS 603 GY. UPTAKE OF THE DELIVERED DOSE TO PERFUSED TUMOR WAS 758 GY. ON 22-NOV-2023, THE SUBJECT PRESENTED FOR A FOLLOW-UP VISIT. DURING THIS TIME, ECOG SCORE WAS 1. ON 15-DEC-2023, 114 DAYS POST INDEX PROCEDURE, THE SUBJECT'S HEALTH CONDITION DETERIORATED. ON THE SAME DAY, THE SUBJECT WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION. DURING THIS TIME, THE SUBJECT WAS NOTED WITH INCREASED WEIGHT TO 99 KG. THE SUBJECT WAS DIAGNOSED WITH EDEMATO-ASCITIC DECOMPENSATION. CONCOMITANT MEDICATION (DIURETIC TREATMENT) WAS ADMINISTRATED, AND ASCITES PUNCTURE WAS PERFORMED AS CORRECTIVE ACTION TO TREAT THE EVENT. LATER, THE SUBJECT'S WEIGHT WAS REDUCED TO 85 KG. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED AND ON THE SAME DAY THE SUBJECT WAS DISCHARGED FROM HOSPITAL.

    Description of Event or Problem · 0

    PROACTIF CLINICAL STUDY: IT WAS REPORTED THAT THE SUBJECT EXPERIENCED EDEMATO-ASCITIC DECOMPENSATION 114 DAYS POST INDEX PROCEDURE. THE SUBJECT WAS HOSPITALIZED, AND INTERVENTION WAS PERFORMED AS A RESULT. PRIOR TO THE INDEX PROCEDURE, ADVANCED MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT DOSIMETRY DOCUMENTED, DOSE TO TOTAL PERFUSED LIVER WAS 614 GY AND DOSE TO TOTAL PERFUSED TUMOR WAS 800 GY. ON (B)(6) 2023, THE SUBJECT WAS ENROLLED INTO THE PROACTIF CLINICAL STUDY AND THE TREATMENT WITH THERASPHERE Y-90 GLASS MICROSPHERES WAS PERFORMED ON THE SAME DAY. THE TYPE OF THERASPHERE INFUSION WAS SELECTIVE. 3.143 GBQ OF THERASPHERE WAS ADMINISTERED TO THE LEFT MEDIAN SECTOR (SEGMENT IV). POST TREATMENT DOSIMETRY DOCUMENTED THE UPTAKE OF THE DELIVERED DOSE TO PERFUSED LIVER WAS 603 GY. UPTAKE OF THE DELIVERED DOSE TO PERFUSED TUMOR WAS 758 GY. ON (B)(6) 2023, THE SUBJECT PRESENTED FOR A FOLLOW-UP VISIT. DURING THIS TIME, ECOG SCORE WAS 1. ON (B)(6) 2023, 114 DAYS POST INDEX PROCEDURE, THE SUBJECT'S HEALTH CONDITION DETERIORATED. ON THE SAME DAY, THE SUBJECT WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION. DURING THIS TIME, THE SUBJECT WAS NOTED WITH INCREASED WEIGHT TO 99 KG. THE SUBJECT WAS DIAGNOSED WITH EDEMATO-ASCITIC DECOMPENSATION. CONCOMITANT MEDICATION (DIURETIC TREATMENT) WAS ADMINISTRATED, AND ASCITES PUNCTURE WAS PERFORMED AS CORRECTIVE ACTION TO TREAT THE EVENT. LATER, THE SUBJECT'S WEIGHT WAS REDUCED TO 85 KG. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED AND ON THE SAME DAY THE SUBJECT WAS DISCHARGED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2388773 THERASPHERE Y-90 (6.5 GBQ) CE MARK MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2361-02 2399388 05060116920390

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention