BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE

    MDR report key: 16137129 · Received January 11, 2023

    Report

    Report Number
    2124215-2023-00898
    Event Type
    Injury
    Date Received
    January 11, 2023
    Date of Event
    June 24, 2022
    Report Date
    January 11, 2023
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE AT TIME OF EVENT AND SEX: FOUR PATIENTS: 61-YEAR-OLD MALE, 84-YEAR-OLD MALE, 65-YEAR-OLD MALE, AND 60-YEAR-OLD MALE. DATE OF EVENT: ESTIMATED USING DATE ARTICLE WAS RECEIVED FOR PUBLICATION. (B)(4). KIM, G.M., & KIM, H. (2023). RADIATION PNEUMONITIS FOLLOWING YTTRIUM-90 RADIOEMBOLIZATION: A KOREAN MULTICENTER STUDY. FRONTIERS IN ONCOLOGY, SEC. CANCER IMAGING AND IMAGE-DIRECTED INTERVENTIONS. DOI: 10.3389/FONC.2023.977160.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE ARTICLE THAT FOUR PATIENTS TREATED WITH THERASPHERE HAD SYMPTOMATIC RADIATION PNEUMONITIS. IN THIS RETROSPECTIVE STUDY, FROM MAY 2009 TO JULY 2021, 782 CONSECUTIVE PATIENTS UNDERWENT RADIOEMBOLIZATION IN TWO INSTITUTES. MEDICAL INTERNAL RADIATION DOSE DOSIMETRY AND PARTITION DOSIMETRY WERE USED FOR GLASS AND RESIN YTTRIUM-90-LABELED MICROSPHERES, RESPECTIVELY. MEDICAL RECORDS AND RADIOLOGICAL FINDINGS WERE RETROSPECTIVELY EVALUATED WITH EMPHASIS ON THE SYMPTOMATIC RADIATION PNEUMONITIS. OF THE 732 PATIENTS WITH LUNG SHUNT STUDY AND FOLLOW-UP, 13 (1.8%) HAD SYMPTOMATIC RADIATION PNEUMONITIS AND WERE TREATED WITH STEROIDS. ALL 13 PATIENTS DID NOT RECEIVE SYSTEMIC CHEMOTHERAPY. ALL 13 PATIENTS HAD HCCS WHICH WERE TREATED WITH GLASS (N = 6) AND RESIN (N = 7) Y90 MICROSPHERES. DYSPNEA (N = 12) AND COUGH (N = 6) WERE THE COMMON SYMPTOMS. THE TIME INTERVAL BETWEEN RADIOEMBOLIZATION AND SYMPTOM ONSET RANGED FROM 1.1 TO 6.7 MONTHS (MEAN, 3.5 MONTHS; MEDIAN, 3.3 MONTHS). SIX PATIENTS DIED DUE TO RADIATION PNEUMONITIS AND RESPIRATORY FAILURE WITHOUT TUMOR PROGRESSION. OF THOSE SIX PATIENTS, TWO WERE TREATED WITH THERASPHERE GLASS Y90 MICROSPHERES. OF THE 721 PATIENTS WHOSE LUNG DOSES WERE CALCULATED, 10 PATIENTS WHO WERE TREATED WITH GLASS (N = 5) AND RESIN (N = 5) Y90 MICROSPHERES HAD RADIATION PNEUMONITIS. AMONG THE PATIENTS WITH RADIATION PNEUMONITIS, ALL FIVE PATIENTS TREATED WITH GLASS Y90 MICROSPHERES HAD ESTIMATED LUNG DOSES > 29 GY, WHEREAS FIVE PATIENTS TREATED WITH RESIN Y 90 MICROSPHERES HAD RELATIVELY WIDE RANGE OF LUNG DOSE REACHING MUCH LOWER VALUE (13.21GY). OF THE FOUR THERASPHERE PATIENTS WITH SYMPTOMATIC RADIATION PNEUMONITIS, ONE PATIENT HAD DYSPNEA AND COUGH WITH SYMPTOM ONSET AFTER RADIOEMBOLIZATION AT 3.3 MONTHS. A SECOND PATIENT HAD A COUGH WITH SYMPTOM ONSET AFTER RADIOEMBOLIZATION AT 6.0 MONTHS. A THIRD PATIENT HAD DYSPNEA WITH SYMPTOM ONSET AFTER RADIOEMBOLIZATION AT 5.5 MONTHS. A FOURTH PATIENT HAD HAD DYSPNEA AND COUGH WITH SYMPTOM ONSET AFTER RADIOEMBOLIZATION AT 2.8 MONTHS. ALL FOUR PATIENTS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192374 Y-90 THERASPHERE MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention