BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 8487476 · Received April 5, 2019

    Report

    Report Number
    3002124543-2019-00030
    Event Type
    Death
    Date Received
    April 5, 2019
    Date of Event
    July 30, 2017
    Report Date
    April 3, 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 · 1

    THE EVENTS WERE REPORTED THROUGH A RETROSPECTIVE CLINICAL TRIAL. THE EVENTS ARE CONSIDERED SERIOUS AND PROBABLY RELATED TO THE THERASPHERE ADMINISTRATION. BTG MEDICAL ASSESSMENT: SUBJECT (B)(6) IS A (B)(6) ASIAN FEMALE. HCC DIAGNOSIS DATE: (B)(6) 2016, NO PRESENCE OF PORTAL HYPERTENSION, NO CIRRHOSIS, (B)(6), NO PRIOR SOREFENIB TREATMENT BEFORE THERASPHERE; NO DISEASE SPECIFIC SURGERY, BASELINE BCLC STAGE: C, AT BASELINE PLATELET COUNT 116 KU/L, WBC 3.5 KU/L, ALBUMINE 34G/L, AST 4XULN, NORMAL BILIRUBIN, AFP 1638, TUMOR INVOLVEMENT IN THE RIGHT LOBE (85MM) WITH PORTAL VEIN THROMBOSIS GRADE 3. TREATED WITH THERASPHERE (B)(6) 2017. ACTIVITY RECORDED AT START OF TREATMENT: 2.24GBQ; LUNG SHUNT FRACTION 4%. FOLLOW-UP VISIT (B)(6) 2017: PLATELET COUNT 102 KU/L, WBC 3.7KU/L, ALBUMINE 29G/L, AST 4XULN, NORMAL BILIRUBIN, AFP 449. FOLLOW-UP VISIT (B)(6) 2017: PLATELET COUNT 279 KU/L, WBC 7.8 KU/L, ALBUMINE 21G/L, AST 3XULN, BILIRUBIN 19 MG/L, AFP 25. ON (B)(6) 2017 THE PATIENT EXPERIENCED ASCITES AND LIMB EDEMA AND WAS ADMITTED TO THE HOSPITAL. ACTION TAKEN: PARACENTESIS SPIRONOLACTONE FUROSEMIDE. PATIENT OUTCOME: RECOVERED/RESOLVED (B)(6) 2017. ON (B)(6) 2017 THE PATIENT EXPERIENCED ASCITES AND BILIRUBIN INCREASE AND WAS HOSPITALIZED. ACTION TAKEN FOR ASCITES: PARACENTESIS. PATIENT OUTCOME: RECOVERED/RESOLVED (B)(6) 2017, ACTION TAKEN FOR ELEVATED BILIRUBIN: NOT PROVIDED, LEAD TO DEATH. THE ABOVE EVENTS WERE NOT REPORTED TO BTG BY THE INVESTIGATOR IN 2017. BLOOD BILIRUBIN INCREASED; LIMB EDEMA; ACITES; DEATH - ANTICIPATED ADVERSE EVENTS LISTED IN THE IFU/RISK MANAGEMENT DOCUMENTATION. BLOOD BILIRUBIN INCREASED - POSSIBLY RELATED TO THERASPHERE AND PATIENT PRE-EXISTING CONDITION. SERIOUS. ASCITES - POSSIBLY RELATED TO THERASPHERE AND PATIENT PRE-EXISTING CONDITION. SERIOUS LIMB EDEMA - POSSIBLY RELATED TO THERASPHERE AND PATIENT PRE-EXISTING CONDITION. SERIOUS DEATH- POSSIBLY RELATED TO THERASPHERE AND PATIENT PRE-EXISTING CONDITION. SERIOUS 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. 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

    THE EVENTS WERE REPORTED THROUGH A RETROSPECTIVE CLINICAL TRIAL. SUBJECT (B)(6) IS A (B)(6) ASIAN FEMALE ENROLLED ON THE (B)(6) STUDY HCC DIAGNOSIS DATE: (B)(6) 2016, NO PRESENCE OF PORTAL HYPERTENSION, NO CIRRHOSIS, (B)(6), NO PRIOR SOREFENIB TREATMENT BEFORE THERASPHERE; NO DISEASE SPECIFIC SURGERY, BASELINE BCLC STAGE: C, AT BASELINE PLATELET COUNT 116 KU/L, WBC 3.5 KU/L, ALBUMINE 34G/L, AST 4XULN, NORMAL BILIRUBIN, AFP 1638, TUMOR INVOLVEMENT IN THE RIGHT LOBE (85MM) WITH PORTAL VEIN THROMBOSIS GRADE 3. TREATED WITH THERASPHERE (B)(6) 2017. ACTIVITY RECORDED AT START OF TREATMENT: 2.24GBQ; LUNG SHUNT FRACTION 4%. FOLLOW-UP VISIT (B)(6) 2017: PLATELET COUNT 102 KU/L, WBC 3.7KU/L, ALBUMINE 29G/L, AST 4XULN, NORMAL BILIRUBIN, AFP 449, FOLLOW-UP VISIT (B)(6) 2017: PLATELET COUNT 279 KU/L, WBC 7.8 KU/L, ALBUMINE 21G/L, AST 3XULN, BILIRUBIN 19 MG/L, AFP 25. PATIENT DIED (B)(6) 2017. ON (B)(6) 2017 THE PATIENT EXPERIENCED ASCITES AND WAS HOSPITALIZED. ACTION TAKEN: PARACENTESIS SPIRONOLACTONE FUROSEMIDE. PATIENT OUTCOME: RECOVERED/RESOLVED (B)(6) 2017. ON (B)(6) 2017 THE PATIENT ALSO EXPERIENCED LIMB EDEMA AND WAS HOSPITALIZED. ACTION TAKEN: FUROSEMIDE SPIRONOLACTONE. PATIENT OUTCOME: RECOVERED/RESOLVED (B)(6) 2017. ON (B)(6) 2017 THE PATIENT EXPERIENCED ASCITES AND WAS HOSPITALIZED. ACTION TAKEN: PARACENTESIS. PATIENT OUTCOME: RECOVERED/RESOLVED (B)(6) 2017. THE ABOVE EVENTS WERE NOT REPORTED TO BTG BY THE INVESTIGATOR IN 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280039 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW NAW BIOCOMPATIBLES UK LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| H| R