BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 10020024 · Received May 4, 2020

    Report

    Report Number
    3002124543-2020-00011
    Event Type
    Death
    Date Received
    May 4, 2020
    Report Date
    April 29, 2020
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY MEDICAL ASSESSMENT COMMENTS: STUDY FROM APRIL 2005 TO DECEMBER 2018, 91 CONSECUTIVE PATIENTS WITH BCLC STAGE C HCC WHO UNDERWENT Y90 SIRT WERE RETROSPECTIVELY ANALYZED. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS THUS TO ASSESS THE OUTCOMES OF PATIENTS WITH CHILD-PUGH B7 DISEASE TREATED WITH Y90 SIRT FOR ADVANCED HCC TO DETERMINE WHETHER OUTCOMES COMPARE MORE TO THOSE WITH CHILD-PUGH A DISEASE VERSUS THOSE WITH MORE ADVANCED, CHILD-PUGH B8/9 LIVER DISEASE. FURTHERMORE, THE WEIGHTED EFFECTS OF THE INDIVIDUAL COMPONENTS OF CHILD-PUGH SCORE WERE ALSO ASSESSED. POPULATION MEAN AGE WAS 63 YEARS AND 85.7% WERE MALE. (B)(6) INFECTION WAS THE MOST COMMON ETIOLOGY OF LIVER DISEASE (58.2%). SIXTY-FOUR (70.3%) PATIENTS WERE CHILD-PUGH A, 19 (20.9%) PATIENTS WERE B7, AND EIGHT (8.8%) PATIENTS WERE B8-9. 64 (70.3%) PATIENTS WERE CHILD-PUGH A, 19 (20.9%) PATIENTS WERE B7, AND 8 (8.6%) PATIENTS WERE B8/9. 55 (60.4%) WERE ECOG SCORE 0, THE MEAN TUMOR SIZE WAS 7.4 CM (RANGE, 2.0-19.8) AND 47 PATIENTS (51.6%) HAD ONE TUMOR. TREATMENT AND FOLLOW-UP THE MEAN ADMINISTERED ACTIVITY OF Y90 WAS 3.30 GBQ (, 0.42-9.45). 80 (87.9%) PATIENTS WERE TREATED WITH LOBAR DELIVERY, AND 11 (12.1%) PATIENTS RECEIVED SEGMENTAL Y90 DELIVERY. FOLLOW-UP CLINICAL AND LABORATORY TESTING WAS DONE ONE MONTH AFTER THE PROCEDURE. CONTRAST-ENHANCED CROSS-SECTIONAL IMAGING WAS PERFORMED ONE MONTH AFTER THE PROCEDURE AND EVERY THREE MONTHS THEREAFTER. RESULTS FREQUENT ADVERSE EVENTS WERE ABDOMINAL/BACK PAIN IN 32 PATIENTS (35.2%), FATIGUE IN 26 PATIENTS (28.6%), NAUSEA/VOMITING IN 15 PATIENTS (16.5%). ONE PATIENT HAD MELENAE AT THE SIXTH-DAY POST-PROCEDURE. 30 DAYS MORTALITY RATE WAS 1.1%. ONE PATIENT WITH PVI AND CHILD-PUGH B7 DISEASE DIED 22 DAYS AFTER RADIOEMBOLIZATION. TESTING AT THAT TIME REVEALED SIGNIFICANT TUMOR PROGRESSION AND LIVER DYSFUNCTION WITH ELEVATED (AST 516 U/L, ALT 243 U/L) AND HYPERAMMONEMIA (71 UMOL/L).

    Description of Event or Problem · 1

    AS PART OF POST-MARKET SURVEILLANCE ACTIVITIES LITERATURE ARTICLE: YTTRIUM-90 RADIOEMBOLIZATION FOR BCLC STAGE C HEPATOCELLULAR CARCINOMA COMPARING CHILD-PUGH A VERSUS B7 PATIENTS: ARE THE OUTCOMES EQUIVALENT? AUTHOR: QINGQUAN ZU ET AL WAS REVIEWED. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO SPECIFICALLY ASSESS THE OUTCOMES OF PATIENTS WITH CHILD-PUGH B7 DISEASE TREATED WITH Y90 RADIOEMBOLIZATION FOR ADVANCED HCC TO DETERMINE WHETHER OUTCOMES COMPARE MORE TO THOSE WITH CHILD-PUGH A DISEASE VERSUS THOSE WITH MORE ADVANCED, CHILD-PUGH B8/9 LIVER DISEASE. FURTHERMORE, THE WEIGHTED EFFECTS OF THE INDIVIDUAL COMPONENTS OF CHILD-PUGH SCORE WERE ALSO ASSESSED. 106 PATIENTS WITH BARCELONA CLINIC LIVER CANCER (BCLC) STAGE C HEPATOCELLULAR CARCINOMA (HCC) WHO UNDERWENT Y90 RADIOEMBOLIZATION (THERASPHERE) AT A TERTIARY REFERRAL CENTER WERE RETROSPECTIVELY ANALYZED IN THIS SINGLE-CENTER STUDY. DATA COLLECTED INCLUDED PATIENT CHARACTERISTICS, LIVER FUNCTION, AND TUMOR CHARACTERISTICS. HCC WAS CONFIRMED BY MULTIPHASIC CONTRAST-ENHANCED ABDOMINAL CT OR MRI, SERUM ALPHA-FETOPROTEIN (AFP) LEVELS, OR BIOPSY. CLINICAL PERFORMANCE STATUS WAS EVALUATED ACCORDING TO THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) SCORE. THE CHILD-PUGH SCORE WAS INDEPENDENTLY ASSESSED AND CATEGORIZED AS: A (SCORE = 5/6), B7 (SCORE = 7), AND B8/9 (SCORE = 8/9)[9]. MACROVASCULAR TUMOR INVASION WAS DIAGNOSED ON CONTRAST-ENHANCED CT/MRI. ADDITIONAL TUMOR CHARACTERISTICS INCLUDING SIZE, LESION NUMBER, DISTRIBUTION, AND GROWTH PATTERN WERE ALSO EVALUATED. FOLLOW-UP CLINICAL AND LABORATORY TESTING WAS DONE ONE MONTH AFTER THE PROCEDURE. CONTRAST-ENHANCED CROSSSECTIONAL IMAGING WAS PERFORMED ONE MONTH AFTER THE PROCEDURE AND EVERY THREE MONTHS THEREAFTER. EVENT: COMMON POST-RADIOEMBOLIZATION ADVERSE EVENTS WERE ABDOMINAL/BACK PAIN IN 32 PATIENTS (35.2%), FATIGUE IN 26 PATIENTS (28.6%), NAUSEA/VOMITING IN 15 PATIENTS (16.5%). ONE PATIENT EXPERIENCED A DARK BLOODY BOWEL MOVEMENT AT THE SIXTH-DAY POST-PROCEDURE. ALL PATIENTS RECOVERED WITH CONSERVATIVE TREATMENT. ONE PATIENT WITH PVI AND CHILD-PUGH B7 DISEASE DIED 22 DAYS AFTER RADIOEMBOLIZATION. TESTING AT THAT TIME REVEALED SIGNIFICANT TUMOR PROGRESSION AND LIVER DYSFUNCTION WITH ELEVATED ASPARTATE AND ALANINE AMINOTRANSFERASES (AST 516 U/L, ALT 243 U/L) AND HYPERAMMONEMIA (71 UMOL/L). FATIGUE, ABDOMINAL PAIN, NAUSEA, ASCITES; ENCEPHALOPATHY, INCREASED ALBUMIN; INCREASED BILIRUBIN; GI BLEED ARE ANTICIPATED ADVERSE EVENT ASSOCIATED WITH SIRT LISTED IN THE IFU/RISK MANAGEMENT DOCUMENTATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485884 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW, PRODUCT NAW BIOCOMPATIBLES UK LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death