BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 8706647 · Received June 18, 2019

    Report

    Report Number
    3002124543-2019-00043
    Event Type
    Death
    Date Received
    June 18, 2019
    Date of Event
    November 13, 2015
    Report Date
    July 5, 2019
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENTS WERE REPORTED THROUGH A RETROSPECTIVE CLINICAL TRIAL. THE EVENTS ARE CONSIDERED SERIOUS DUE TO HOSPITALIZATION AND RELATED TO THERASPHERE ADMINISTRATION. UPDATED BTG MEDICAL ASSESSMENT: (B)(6) 2019. SUBJECT (B)(4) IS A 53-YEAR-OLD, WHITE MALE PATIENT ENROLLED ON THE TARGET STUDY. DIAGNOSED WITH HCC ON (B)(6) 2015. PRESENCE OF PORTAL HYPERTENSION WITH ESOPHAGEAL VARICES GRADE 2 ETIOLOGIC ASSOCIATIONS: LIVER CIRRHOSIS. HEPATITIS B. HEPATITIS C. ALCOHOL ADDICTION. NO PRIOR SORAFENIB TREATMENT BEFORE THERASPHERE® NO DISEASE SPECIFIC SURGERY. MEDICAL HISTORY OF PULMONARY SARCOIDOSIS, AND COPD,START DATE UNKNOWN LONG SMOKING HISTORY. AFP (B)(4). NO LIVER LESION IS DOCUMENTED IN THE PATIENT ELECTRONIC FILE. THERASPHERE TREATMENT DATE: (B)(6) 2015. NO CONCOMITANT MEDICATION. LEFT LOBE TREATED. ACTIVITY ADMINISTERED: 2.0 GBQ - 0.036 (RESIDUE) = 1.964 GBQ; TRUE LOBAR ACTIVITY = 1.964 GBQ * ( 1- 0.07) = 1.83 GBQ. LUNG SHUNT FRACTION: 7%. ACTIVITY TO LUNG 0.13 GBQ. DOSE TO LUNG=6.7 GY. (B)(6) 2015 PATIENT EXPERIENCED ASCITES (GRADE 1) - NON-SERIOUS ADVERSE EVENT. FIRST FU OCCURRED ON THE (B)(6) OF 2015. ECOG =3. BILIRUBIN= 4 MG/ML. ALBUMIN 25G/L. AFP (B)(4). CONCLUSION = HEPATIC DECOMPENSATION, REPORTED AS SERIOUS ADVERSE EVENT - PERSISTENT OR SIGNIFICANT DISABILITY/INCAPACITY RESULTING IN DEATH ((B)(6) 2016). ALSO ELEVATION OF AFP COULD BE RELATED TO DISEASE PROGRESSION. ADDITIONAL INFORMATION RECEIVED (B)(6) 2019 AS FOLLOWS: DOSE WITHIN IFU DOSE: WE DELIVERED 47 GY TO LIVER, WELL BELOW THE LIMIT OF 150 GY. LOBAR DOSE WAS HIGH SINCE THE INJECTED VOLUME FRACTION WAS SMALL, AND THE TREATMENT SAFE, AND INTENTIONALLY CURATIVE. DATE UNKNOWN: DYSPNOEA (GRADE 3) SERIOUS - LED TO INITIAL OR PROLONGED HOSPITALIZATION (ADMISSION AND DISCHARGE DATES NOT REPORTED); START DATE UNKNOWN. THE PATIENT HAS CHRONIC RESPIRATORY DISEASE (SARCOIDOSIS AND COPD AND HEAVY SMOKER) THAT MAY HAVE DECOMPENSATED, FAVOURED BY THE HEPATIC DECOMPENSATION. REGARDING THE TS ACTIVITY ADMINISTERED AND LUNG SHUNT, THE OCCURRENCE OF A RADIATION INDUCED PNEUMONITIS IS NOT POSSIBLE (DELAY AND LUNG DOSE). THE PATIENT DID NOT ACTUALLY EXPERIENCED REILD. HE EXPERIENCED LIVER DECOMPENSATION AT MONTH 1.5, CONCOMITANT WITH ALPHAFE TO PROTEIN JUMP FROM 15365 I.U./ ML TO 17571 I.U./ ML. LIVER DECOMPENSATION IS CLEARLY IMPUTABLE TO TUMOUR PROGRESSION, AND IT IS NOT TREATMENT RELATED. THEREFORE IT IS NOT RADIO EMBOLIZATION INDUCED. ASCITES: GRADE 1; NON-SERIOUS; RELATED TO DEVICE; EXPECTED. DYSPNOEA: GRADE 3; SERIOUS; NOT RELATED TO DEVICE; EXPECTED. HEPATIC DECOMPENSATION: GRADE 4; SERIOUS; RELATED TO DISEASE PROGRESSION; EXPECTED. DEATH: GRADE 5; SERIOUS; RELATED TO DISEASE PROGRESSION; EXPECTED. ALL EVENTS ARE ANTICIPATED ADVERSE EVENTS LISTED IN THE RISK MANAGEMENT DOCUMENTATION/IFU. 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. 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 · 0

    ADDITIONAL INFORMATION RECEIVED (B)(6) 2019 AS FOLLOWS: INVESTIGATOR REPORTED ACTIVITY ADMINISTERED: 2.0 GBQ - 0.036 (RESIDUE) = 1.964 GBQ; LSF = 7%; TRUE LOBAR ACTIVITY = 1.964 GBQ * ( 1- 0.07) = 1.83 GBQ DOSE WITHIN IFU DOSE: WE DELIVERED 47 GY TO LIVER, WELL BELOW THE LIMIT OF 150 GY. LOBAR DOSE WAS HIGH SINCE THE INJECTED VOLUME FRACTION WAS SMALL, AND THE TREATMENT SAFE, AND INTENTIONALLY CURATIVE. RCA OF DEATH: THE PATIENT DID NOT ACTUALLY EXPERIENCED REILD. HE EXPERIENCED LIVER DECOMPENSATION AT MONTH 1.5, CONCOMITANT WITH ALPHAFE TO PROTEIN JUMP FROM 15365 I.U./ ML TO 17571 I.U./ ML. LIVER DECOMPENSATION IS CLEARLY IMPUTABLE TO TUMOUR PROGRESSION, AND IT IS NOT TREATMENT RELATED. THEREFORE IT IS NOT RADIO EMBOLIZATION INDUCED.

    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: ON (B)(6) 2015 PATIENT EXPERIENCED ASCITES (GRADE 1) - NON-SERIOUS ADVERSE EVENT DATE UNKNOWN: DYSPNOEA (GRADE 3) SERIOUS - LED TO INITIAL OR PROLONGED HOSPITALIZATION (ADMISSION AND DISCHARGE DATES NOT REPORTED); START DATE UNKNOWN. ON (B)(6) 2015: HEPATIC DECOMPENSATION, REPORTED AS SERIOUS ADVERSE EVENT - PERSISTENT OR SIGNIFICANT DISABILITY/INCAPACITY RESULTING IN DEATH ((B)(6) 2016). THE PATIENT HAS CHRONIC RESPIRATORY DISEASE (SARCOIDOSIS AND COPD AND HEAVY SMOKER) THAT MAY HAVE DECOMPENSATED, FAVOURED BY THE HEPATIC DECOMPENSATION. REGARDING THE TS ACTIVITY ADMINISTERED AND LUNG SHUNT, THE OCCURRENCE OF A RADIATION INDUCED PNEUMONITIS IS NOT POSSIBLE (DELAY AND LUNG DOSE). ALSO THE DISEASE HAS PROGRESSED FROM BASELINE, THAT MIGHT HAS FAVOURED THE HEPATIC DECOMPENSATION. ALL EVENTS ARE ANTICIPATED ADVERSE EVENTS LISTED IN THE RISK MANAGEMENT DOCUMENTATION/IFU. 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. 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)(6) 27-MAY-2019 SUBJECT (B)(6) IS A (B)(6)-YEAR-OLD, WHITE MALE PATIENT ENROLLED ON THE (B)(6) STUDY. DIAGNOSED WITH HCC ON (B)(6) 2015 PRESENCE OF PORTAL HYPERTENSION WITH ESOPHAGEAL VARICES GRADE 2. ETIOLOGIC ASSOCIATIONS: LIVER CIRRHOSIS, (B)(6), ALCOHOL ADDITION, NO PRIOR SORAFENIB TREATMENT BEFORE THERASPHERE®; NO DISEASE SPECIFIC SURGERY; MEDICAL HISTORY OF PULMONARY SARCOIDOSIS, AND COPD, START DATE UNKNOWN; LONG SMOKING HISTORY; AFP 15365, TARGET LESION: LIVER LEFT LOBE, LONGEST DIAMETER 60MM, ASSESSMENT DATE (B)(6) 2015 BY CB SCAN, UNILOBAR DISEASE, NO PVT PRESENT, NO ASCITES PRESENT, NO SPLENOMEGALY. THERASPHERE TREATMENT DATE: (B)(6) 2015. NO CONCOMITANT MEDICATION. LEFT LOBE TREATED. ACTIVITY ADMINISTERED= 1. 93 GBQ. LUNG SHUNT FRACTION: 7%. FIRST FOLLOW UP OCCURRED ON THE (B)(6) OF 2015. ECOG =3, BILIRUBIN= 4 MG/ML, ALBUMIN 25G/L, AFP 17571. ON (B)(6) 2015 PATIENT EXPERIENCED ASCITES (GRADE 1) - NON-SERIOUS ADVERSE EVENT DATE UNKNOWN: DYSPNOEA (GRADE 3) SERIOUS - LED TO INITIAL OR PROLONGED HOSPITALIZATION (ADMISSION AND DISCHARGE DATES NOT REPORTED); ON (B)(6) 2015: HEPATIC DECOMPENSATION (GRADE 5), REPORTED AS SERIOUS ADVERSE EVENT - PERSISTENT OR SIGNIFICANT DISABILITY/INCAPACITY RESULTING IN DEATH ((B)(6) 2016). THE EVENTS WERE NOT REPORTED TO BTG BY THE INVESTIGATOR IN 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503153 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW NAW BIOCOMPATIBLES UK LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death| H