BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE

    MDR report key: 19762200 · Received July 17, 2024

    Report

    Report Number
    2124215-2024-43189
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    April 3, 2021
    Report Date
    July 17, 2024
    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). D3: MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK D3: MANUFACTURER ZIP/POSTAL CODE: GU9 8QL.

    Description of Event or Problem · 0

    PROACTIF CLINICAL STUDY IT WAS REPORTED THAT UPPER GASTROINTESTINAL BLEEDING OCCURRED. STANDARD, SINGLE COMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT MACRO AGGREGATED ALBUMIN (MAA) DOSIMETRY DOCUMENTED, DOSE TO TOTAL PERFUSED LIVER AS 427 GY. DOSE TO TOTAL PERFUSED TUMOR WAS 299 GY. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS LEFT LIVER. THE CATHETER WAS POSITIONED IN THE CELIAC ARTERY CATHETERIZATION USING A NON-BOSTON SCIENTIFIC 4F CATHETER: 2.178 GBQ OF THERASPHERE WAS ADMINISTERED TO THE LEFT LIVER THROUGH VIAL 1. POST TREATMENT DOSIMETRY DOCUMENTED AN UPTAKE OF THE DELIVERED DOSE; TO TOTAL PERFUSED LIVER WAS 127 GY AND TO TOTAL PERFUSED TUMOR WAS 308 GY. ON (B)(6) 2021, 80 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH UPPER GASTROINTESTINAL BLEEDING. ON THE SAME DAY, THE SUBJECT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR FURTHER EVALUATION AND TREATMENT. TWO UPPER DIGESTIVE ENDOSCOPIES WITH ESOPHAGEAL VARICES LIGATION WERE PERFORMED. SCLEROTHERAPY WITH FIBEROPTIC GASTRO DUODENOSCOPY (FOGD) WAS ATTEMPTED, HOWEVER THE BLEEDING PERSISTED TILL THE END OF THE PROCEDURE. ON (B)(6) 2021, THE SUBJECT WAS DIAGNOSED WITH UPPER GASTROINTESTINAL HEMORRHAGE. ADDITIONALLY, ON THE SAME DAY CHEST X-RAY RESULTS REVEALED SMALL RIGHT PLEURAL EFFUSION. BLOOD TRANSFUSION OF 2 FRESH-FROZEN PLASMA (FFP) WAS DONE. ADDITIONALLY, PROTON PUMP INHIBITORS (PPI), SANDOSTATIN INTRAVENOUS, ANTIBIOTIC PROPHYLAXIS WITH C3G WAS CONTINUED AS A TREATMENT. ON (B)(6) 2021, NO RECURRENCE OF BLEEDING NOTED. ON THE SAME DAY, PLEURAL EVACUATION WAS PERFORMED AS A CORRECTIVE ACTION FOR THE PLEURAL EFFUSION. ON (B)(6) 2021, 84 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH ACUTE RESPIRATORY DISTRESS DUE TO WHICH THE HOSPITALIZATION WAS PROLONGED. ACUTE RESPIRATORY DISTRESS WAS DUE TO THE LARGE RIGHT PLEURAL EFFUSION AND ACUTE BILATERAL PNEUMOPATHY WITH GROUND GLASS. THE OTHER CONCURRENT DISEASE WAS RIGHT PLEURAL EFFUSION ASSOCIATED WITH INFECTIOUS PNEUMONITIS. CHEST DRAIN WAS PLACED, AND OXYGEN THERAPY WAS INITIATED UPON WHICH FAVORABLE OUTCOME WAS NOTED. MEDICATION WAS ADMINISTRATED AND SURGERY WAS PERFORMED TO TREAT THE EVENT. ON (B)(6) 2021, THERE WAS AN EMERGENCY CONSULTATION DUE TO RECURRENCE OF 3 EPISODES OF MELENA. ON (B)(6) 2021, THERE WAS A SIGNIFICANT INCREASE IN RIGHT PLEURAL EFFUSION WITH BILATERAL PULMONARY OPACITIES WHICH WAS SUGGESTIVE OF AN INFECTIOUS ORIGIN. DURING THE HOSPITALIZATION, THE RESPIRATORY FUNCTION WAS DETERIORATED. ON (B)(6) 2021, IN THE INTENSIVE CARE, TRANSFUSION OF TOTAL 10 RBCS AND 2 FRESH-FROZEN PLASMA (FFPS) AND ESOPHAGEAL VARICES LIGATION WAS PERFORMED, TO TREAT THE EVENT OF UPPER GASTROINTESTINAL BLEEDING. ON (B)(6) 2021, THE EVENT OF UPPER GASTROINTESTINAL BLEEDING WAS CONSIDERED RESOLVED. ON (B)(6) 2021, 120 DAYS POST INDEX PROCEDURE, THE SUBJECT PASSED AWAY DUE TO ACUTE RESPIRATORY DISTRESS. THE EVENT OF ACUTE RESPIRATORY DISTRESS RESULTING IN DEATH WAS ASSESSED AS NOT RELATED TO THE THERASPHERE DEVICE OR THE ADMINISTRATION PROCEDURE BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366586 Y-90 THERASPHERE MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| R