BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90

    MDR report key: 22017814 · Received May 14, 2025

    Report

    Report Number
    2124215-2025-30760
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    October 24, 2024
    Report Date
    May 14, 2025
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 64 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. A4 - WEIGHT: 84.30 KG. BASED ON THE NATURE OF THE PRODUCT, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA STUDY THAT THE SUBJECT EXPERIENCED AN ESOPHAGEAL VARICES HEMORRHAGE. THE SUBJECT WAS ENROLLED INTO THE STUDY ON (B)(6) 2024. PRETREATMENT MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 0.3 %. ON (B)(6) 2024, THERASPHERE TREATMENT WAS PERFORMED. TWO DOSE VIALS WERE ADMINISTERED THROUGH THE FEMORAL ARTERY. THE TOTAL THERASPHERE ACTIVITY ADMINISTERED ACTIVITY WAS 2.18GBQ. ON (B)(6) 2024, 83 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF BLACK STOOLS AND WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY WITH THE CONCERNS OF ESOPHAGEAL VARICES HEMORRHAGE. ON THE SAME DAY, HEMOGLOBIN WAS 13.7. ESOPHAGOGASTRODUODENOSCOPY NOTED A SINGLE OF GRADE III ESOPHAGEAL NONBLEEDING VARIX WITH RED WALE SIGN STATUS POST BANDING X1 WITH COMPLETE ERADICATION. ANOTHER GRADE II VARIX WITHOUT HIGH-RISK FEATURES WAS OBSERVED. LOS ANGELES (LA) GRADE A ESOPHAGITIS, AND DIFFUSE HYPERTENSIVE GASTROPATHY WERE ALSO NOTED. THE EVENT WAS TREATED WITH PANTOPRAZOLE (PROTONIX) (40MG/TWICE DAILY, (B)(6) 2024- ONGOING) AND SULFAMETHOXAZOLE-TRIMETHOPRIM (BACTRIM DS) (800-160MG PER TABLET/TWICE DAILY, (B)(6) 2024). NO ACTION WAS TAKEN WITH REGARDS TO THE STUDY TREATMENT AND STUDY MEDICATIONS. THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749670 THERASPHERE Y-90 MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| R