BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 8598829 · Received May 10, 2019

    Report

    Report Number
    3002124543-2019-00042
    Event Type
    Injury
    Date Received
    May 10, 2019
    Date of Event
    December 15, 2011
    Report Date
    June 2, 2019
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED 02-JUN-2019. BTG MEDICAL ASSESSMENT - UPDATED 10-JUN-2019. THE PATIENT EXPERIENCED ASCITES AND LIMBS OEDEMA, THAT REQUIRED MEDICATION WITH FUROSEMIDE AND SPIRONOLACTONE. IT IS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR TREATMENT BUT DATE OF HOSPITALIZATION AND DISCHARGE ARE NOT REPORTED. ON (B)(6) 2012 IT IS DOCUMENTED IN THE CT SCAN THAT THE PATIENT HAS ASCITES GRADE 2, LAB TEST REVEALED ELEVATED BILIRUBIN. TREATMENT PERFORMED FOR ELEVATED BILIRUBIN UNKNOWN. OUTCOME UNKNOWN. ALSO THE PATIENT AS PORTAL HYPERTENSION AT BASELINE ASCITES, BLOOD BILIRUBIN INCREASE AND EDEMA LIMBS REQUIRING HOSPITALIZATION: SERIOUS ADVERSE EVENTS, SEVERITY 3, CAUSALITY - RELATED TO THERASPHERE, ALL ANTICIPATED ADVERSE EVENTS LISTED IN THE IFU/RISK MANAGEMENT DOCUMENTATION. NO DEVICE MALFUNCTION WAS REPORTED AND NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN HAS BEEN IDENTIFIED. THE LOT NUMBER ASSOCIATED WITH THE THERASPHERE ADMINISTRATION WAS NOT REPORTED, THEREFORE NO INVESTIGATION COULD BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME THIS REPORT IS CONSIDERED FINAL.

    Description of Event or Problem · 0

    ADDITIONAL AUTO-NOTIFICATION FROM DATATRAK RECEIVED: 02-JUN-2019 PATIENT EXPERIENCED: ASCITES ON (B)(6) 2011. REPORTED AS GRADE 3; SEVERE; DIURETIC ONLY ADMINISTERED - NO OTHER ACTION TAKEN; SERIOUS ADVERSE EVENT DUE TO PERSISTENT OR SIGNIFICANT DISABILITY OR INCAPACITY AND INITIAL OR PROLONGED HOSPITALIZATION; PROBABLY RELATED TO DEVICE. OUTCOME UNKNOWN. BLOOD BILIRUBIN INCREASED ON (B)(6) 2012. REPORTED AS GRADE 3; SEVERE; SUPPORTIVE TREATMENT (NOT SPECIFIED); SERIOUS ADVERSE EVENT DUE TO PERSISTENT OR SIGNIFICANT DISABILITY OR INCAPACITY. PROBABLY RELATED TO DEVICE. OUTCOME UNKNOWN. THE EVENTS WERE NOT REPORTED TO BTG BY THE INVESTIGATOR IN 2011.

    Additional Manufacturer Narrative · 1

    THE EVENTS WERE REPORTED THROUGH A RETROSPECTIVE CLINICAL TRIAL. THE EVENTS ARE CONSIDERED SERIOUS DUE TO HOSPITALIZATION AND RELATED TO THERASPHERE ADMINISTRATION. BTG MEDICAL ASSESSMENT: SUBJECT: (B)(6) IS A (B)(6) YEAR OLD MALE PATIENT ENROLLED IN THE (B)(6) STUDY. DIAGNOSED WITH HCC (B)(6) 2011. PRESENCE OF PORTAL HYPERTENSION (B)(6) 2011. AETIOLIGIC ASSOCIATIONS: LIVER CIRRHOSIS; NON ALCOHOLIC STEATOHEPATITITS. NO PRIOR SORAFENIB TREATMENT. BASELINE BCLC STAGE: C. NO DISEASE SPECIFIC SURGERY. PRESENCE OF PORTAL MAIN BRANCH THROMBOSIS, NO ASCITES AT BASELINE AND LOW PLATELET COUNT. BILOBAR DISEASE. TREATED WITH THERASPHERE (B)(6) 2011. ACTIVITY RECORDED AT START OF INFUSION: GBQ 5.03. RESIDUALS REMAINING IN DELIVERY SET: GBQ 0.48. TOTAL ADMINISTERED: GBQ 4.55. LUNG SHUNT FRACTION 15.7%. THERASPHERE ADMINISTERED IN THE RIGHT HEPATIC ARTERY. PATIENT EXPERIENCED: ASCITES AND EDEMA LIMBS ON AN UNKNOWN DATE IN (B)(6) 2011. TREATMENT RECEIVED FUROSEMIDE AND SPIRONOLACTONE. ASCITES AND EDEMA LIMBS REQUIRING HOSPITALIZATION: SERIOUS ADVERSE EVENTS, SEVERITY 3, CAUSALITY - RELATED TO THERASPHERE, ANTICIPATED ADVERSE EVENTS LISTED IN THE IFU/RISK MANAGEMENT DOCUMENTATION. NO DEVICE MALFUNCTION WAS REPORTED AND NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN HAS BEEN INDENTIFIED. THE LOT NUMBER ASSOCIATED WITH THE THERASPHERE ADMINISTRATION WAS NOT REPORTED, THEREFORE NO INVESTIGATION COULD BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. NO OTHER INFORMATION IS AVAILABLE THAT COULD CONFIRM/DENY THE ALLEGED EVENT. AT THIS TIME, THIS REPORT IS CONSIDERED FINAL.

    Description of Event or Problem · 1

    AUTO-NOTIFICATION RECEIVED FROM (B)(4) 08-MAY-2019. SUBJECT: (B)(6) IS A (B)(6) YEAR OLD MALE PATIENT ENROLLED IN THE (B)(6) STUDY. DIAGNOSED WITH HCC (B)(6) 2011. PRESENCE OF PORTAL HYPERTENSION (B)(6) 2011. AETIOLIGIC ASSOCIATIONS: LIVER CIRRHOSIS; NON ALCOHOLIC STEATOHEPATITITS. NO PRIOR SORAFENIB TREATMENT. BASELINE BCLC STAGE: C. NO DISEASE SPECIFIC SURGERY. PRESENCE OF PORTAL MAIN BRANCH THROMBOSIS, NO ASCITES AT BASELINE AND LOW PLATELET COUNT. BILOBAR DISEASE. TREATED WITH THERASPHERE (B)(6) 2011. ACTIVITY RECORDED AT START OF INFUSION: GBQ 5.03. RESIDUALS REMAINING IN DELIVERY SET: GBQ 0.48. TOTAL ADMINISTERED: GBQ 4.55. LUNG SHUNT FRACTION 15.7%. PATIENT EXPERIENCED: ASCITES AND EDEMA LIMBS ON AN UNKNOWN DATE IN (B)(6) 2011. TREATMENT RECEIVED FUROSEMIDE SPIRNOLACTONE. ADDITIONAL INFORMATION RECEIVED 08-MAY-2019. THE PATIENT WAS HOSPITALIZED. THE EVENTS WERE NOT REPORTED TO BTG BY THE INVESTIGATOR IN 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392555 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW NAW BIOCOMPATIBLES UK LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization