BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE

    MDR report key: 17187391 · Received June 22, 2023

    Report

    Report Number
    2124215-2023-32603
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    March 22, 2023
    Report Date
    July 25, 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: DATE OF BIRTH: (B)(6)1985. 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.

    Additional Manufacturer Narrative · 0

    A2: DATE OF BIRTH: ON (B)(6) 1985. 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 HEPATIC NECROSIS FOLLOWING A THERASPHERE PROCEDURE. STANDARD, SINGLE COMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS THE TREATMENT DOSE. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) DOSIMETRY DOCUMENTED, DOSE TO TOTAL PERFUSED LIVER AS 106 GY. DOSE TO TOTAL PERFUSED TUMOR WAS NOT DETERMINED. ON (B)(6)2022, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. THE TYPE OF THERASPHERE INFUSION WAS RIGHT LIVER. THE CATHETER POSITIONING WAS NOT DOCUMENTED; 2.05 GBQ OF THERASPHERE WAS ADMINISTERED TO THE RIGHT LIVER THROUGH VIAL 1. POST DOSIMETRY RESULTS WERE NOT DETERMINED. ON (B)(6)2023, 183 DAYS POST INDEX PROCEDURE, THE SUBJECT'S HEALTH CONDITION DETERIORATED. ON (B)(6)2023, THE SUBJECT WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION. DURING THE COURSE OF HOSPITALIZATION, THE SUBJECT WAS DIAGNOSED WITH HEPATIC NECROSIS. THE SUBJECT WAS TREATED WITH CONCOMITANT MEDICATION AND A SURGICAL INTERVENTIONAL RADIOLOGY PROCEDURE WAS PERFORMED AS CORRECTIVE ACTIONS TO TREAT THE EVENT. THE HEPATIC NECROSIS WAS NOTED TO BE DUE TO HEPATIC ARTERIAL THROMBOSIS. ON (B)(6)2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 0

    PROACTIVE CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEPATIC NECROSIS FOLLOWING A THERMOSPHERE PROCEDURE. STANDARD, SINGLE COMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS THE TREATMENT DOSE. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) DOSIMETRY DOCUMENTED, DOSE TO TOTAL PERFUSED LIVER AS 106 GY. DOSE TO TOTAL PERFUSED TUMOR WAS NOT DETERMINED. ON (B)(6) 2022, THE SUBJECT WAS ENROLLED INTO THE PROACTIVE STUDY AND THE TREATMENT WITH THERMOSPHERE WAS PERFORMED ON THE SAME DAY. THE TYPE OF THERMOSPHERE INFUSION WAS RIGHT LIVER. THE CATHETER POSITIONING WAS NOT DOCUMENTED; 2.05 GBQ OF THERMOSPHERE WAS ADMINISTERED TO THE RIGHT LIVER THROUGH VIAL 1. POST DOSIMETRY RESULTS WERE NOT DETERMINED. ON (B)(6) 2023, 183 DAYS POST INDEX PROCEDURE, THE SUBJECT'S HEALTH CONDITION DETERIORATED. ON (B)(6) 2023, THE SUBJECT WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION. DURING THE COURSE OF HOSPITALIZATION, THE SUBJECT WAS DIAGNOSED WITH HEPATIC NECROSIS. THE SUBJECT WAS TREATED WITH CONCOMITANT MEDICATION AND A SURGICAL INTERVENTIONAL RADIOLOGY PROCEDURE WAS PERFORMED AS CORRECTIVE ACTIONS TO TREAT THE EVENT. THE HEPATIC NECROSIS WAS NOTED TO BE DUE TO HEPATIC ARTERIAL THROMBOSIS. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. IT WAS FURTHER REPORTED THAT THERE WAS THERMOSPHERE DEPOSITION NOTED IN THE HEPATIC ARTERY WHICH LED TO THE HEPATIC ARTERIAL THROMBOSIS, AND PATHOPHYSIOLOGICALLY, THE THROMBOSIS LED TO NECROSIS OF THE HEPATIC PARENCHYMA, WHICH LED TO PERSISTENT SEPSIS. SEPSIS WAS A COMPLICATION OF HEPATIC NECROSIS BY SUPERINFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68558 Y-90 THERASPHERE MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Hospitalization| R