BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 6105693 · Received November 16, 2016

    Report

    Report Number
    3002124545-2016-00066
    Event Type
    Death
    Date Received
    November 16, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 25, 2016
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFILTRATIVE DISEASE [POST PROCEDURAL COMPLICATION]; CACHEXIA [CACHEXIA]; DECOMPENSATED STATE [HEPATIC FAILURE]; ASCITES [ASCITES]; ABDOMINAL DISCOMFORT [ABDOMINAL DISCOMFORT] ; ABDOMINAL DISTENTION [ABDOMINAL DISTENSION]; WEIGHT GAIN [WEIGHT INCREASED]. CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 25-OCT-2016: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A PHYSICIAN CONCERNING A (B)(6)-YEAR-OLD NON-(B)(6), WHITE MALE PATIENT, WEIGHING (B)(6). THE PATIENT HAD A CHILD PUGH A WITH BCLC B HCC, SINCE AN UNKNOWN DATE. THE PATIENT'S ADDITIONAL MEDICAL HISTORY INCLUDED KNEE REPLACEMENTS, HYPERTENSION, ALCOHOLIC CIRRHOSIS, ALL SINCE AN UNKNOWN DATE. THE PATIENT WAS ALSO AN ALCOHOLIC, BUT HE WAS REPORTED TO HAVE STOPPED DRINKING BEFORE THE INITIATION OF THE TREATMENT. THE PATIENT HAD DESCRIBED TRANSIENT ASCITES PREVIOUSLY BUT WAS WITHOUT ASCITES ON THE REPORTING PHYSICIAN'S IMAGING PROCEDURE OVER 3 MONTHS. THE PATIENT WAS NOT TAKING CONCOMITANT MEDICATIONS. ON (B)(6) 2016, THE PATIENT RECEIVED 5.942 GBQ OF THERASPHERE YTTRIUM-90 GLASS MICROSPHERES (LOT NUMBER 1699201, VIAL 105 AND UNKNOWN EXPIRATION DATE) ADMINISTERED TO THE RIGHT HEPATIC ARTERY AS ONE TIME DELIVERY FOR HCC. ON (B)(6) 2016, AFTER TREATMENT WITH THERASPHERE, THE PATIENT'S LABORATORY VALUES WERE: TOTAL BILIRUBIN 1.1 AND ALKALINE PHOSPHATASE 138. THE PATIENT INITIALLY DID WELL WITH Y90 TREATMENT; HOWEVER, ON AN UNSPECIFIED DATE IN (B)(6) 2016, ABOUT ONE WEEK AFTER THE TREATMENT, THE PATIENT DEVELOPED ABDOMINAL DISTENSION AND DISCOMFORT AND WAS FOUND TO HAVE MODERATE ASCITES. THE PATIENT ALSO EXPERIENCED CONCOMITANT CACHEXIA WITH WEIGHT GAIN. THE REPORTING PHYSICIAN STATED THAT THAT TIME PERIOD WAS TOO RAPID FOR RADIOEMBOLIZATION-INDUCED LIVER DISEASE (REILD), BUT THE PATIENT WAS PRESUMED TO HAVE BEEN PUSHED INTO A DECOMPENSATED STATE FROM THE MINOR TRANSIENT STRESS TO THE LIVER FROM THE PROCEDURE AND INFLAMMATION. AS SUCH, HE WAS PRESCRIBED WITH STEROIDS AND URSODIOL TO PREVENT REILD BECAUSE OF AN INFILTRATIVE DISEASE. ON (B)(6) 2016, THE PATIENT'S LABORATORY VALUES WERE: TOTAL BILIRUBIN 1.4, ALKALINE PHOSPHATASE 120 AND ALPHA 1 FOETOPROTEIN 192. ON (B)(6)2016, THE PATIENT'S TOTAL BILIRUBIN WAS 1.9 AND HIS ALKALINE PHOSPHATASE WAS 129. THE PATIENT'S DECOMPENSATED STATE DID NOT IMPROVE OVER THE FOLLOWING WEEKS, AND ON (B)(6)2016, APPROXIMATELY 1.25 MONTHS AFTER THE TREATMENT WITH THERASPHERE, THE PATIENT DIED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS NOT REPORTED. THE OUTCOME OF THE EVENTS INFILTRATIVE DISEASE, ASCITES, ABDOMINAL DISTENSION, ABDOMINAL DISCOMFORT, CACHEXIA AND WEIGHT GAIN WAS UNKNOWN. THE PHYSICIAN DID NOT ASSESS THE SERIOUSNESS OF THE EVENTS, BUT CONSIDERED THE ASCITES TO BE UNRELATED TO THE USE OF THE THERASPHERE. THE PHYSICIAN DID NOT PROVIDE AN ASSESSMENT OF THE OTHER EVENTS RELATEDNESS TO THE ADMINISTRATION OF THE THERASPHERE. THE COMPANY CONSIDERED THE EVENT HEPATIC DECOMPENSATION, INFILTRATIVE DISEASE, CACHEXIA AND ASCITES AS SERIOUS (FATAL, MEDICALLY SIGNIFICANT) AND THE EVENTS ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION AND WEIGHT INCREASED AS NON-SERIOUS. FOLLOW-UP INFORMATION WILL BE REQUESTED. COMPANY COMMENT: POST PROCEDURAL COMPLICATION, CACHEXIA, ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION AND WEIGHT INCREASED ARE CONSIDERED UNLISTED, AND THE EVENTS HEPATIC DECOMPENSATION AND ASCITES ARE CONSIDERED LISTED ACCORDING TO THERASPHERE CURRENT REFERENCE SAFETY INFORMATION. THE PHYSICIAN CONSIDERED THE EVENT ASCITES AS UNRELATED TO THE USE OF THERASPHERE, AS THE EVENT OCCURRED RIGHT BEFORE OR RIGHT AT THE TIME OF THE PROCEDURE AND THE PATIENT HAD ASSOCIATED DECOMPENSATION WITHOUT IMPROVEMENT OVER THE FOLLOWING WEEKS. IN AGREEMENT WITH THE REPORTING PHYSICIAN, THE COMPANY CONSIDERED THE EVENT OF ASCITES AS NOT RELATED TO THE PRODUCT, BUT DUE TO GENERAL CONDITION OF THE PATIENT WHO HAD PROGRESSIVE DISEASE AND INFILTRATIVE DISEASE. IN THE ABSENCE OF THE PHYSICIAN'S ASSESSMENT, THE COMPANY CONSIDERED THE EVENT OF HEPATIC DECOMPENSATION AS POSSIBLY RELATED TO THE TREATMENT AND THE EVENTS POST-PROCEDURAL COMPLICATION AND CACHEXIA NOT RELATED TO THERASPHERE, BUT DUE TO GENERAL CONDITION OF THE PATIENT WHO HAD PROGRESSIVE DISEASE AND INFILTRATIVE DISEASE. THE COMPANY CONSIDERED THE EVENTS WEIGHT INCREASED AND ABDOMINAL DISTENSION NOT RELATED TO THE TREATMENT BUT DUE TO ASCITES. THE COMPANY ALSO CONSIDERED ABDOMINAL DISCOMFORT AS PROBABLY RELATED TO DISTENSION WHICH IS ASCITES RELATED. NO EVIDENCE TO SUGGEST THERE IS MALFUNCTION OF DEVICE.

    Description of Event or Problem · 1

    SLOWLY PROGRESSED HCC. LIVER DECOMPENSATION. TRANSIENT HEPATITIS FROM RADIOEMBOLIZATION [RADIATION HEPATITIS]. CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 25-OCT-2016: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A PHYSICIAN CONCERNING A (B)(6) MALE PATIENT, WEIGHING (B)(6). THE PATIENT HAD A CHILD PUGH A WITH BCLC B HCC, SINCE AN UNKNOWN DATE. THE PATIENT'S ADDITIONAL MEDICAL HISTORY INCLUDED KNEE REPLACEMENTS, HYPERTENSION, ALCOHOLIC CIRRHOSIS, ALL SINCE AN UNKNOWN DATE. THE PATIENT WAS ALSO AN ALCOHOLIC, BUT HE WAS REPORTED TO HAVE STOPPED DRINKING BEFORE THE INITIATION OF THE TREATMENT. THE PATIENT HAD DESCRIBED TRANSIENT ASCITES PREVIOUSLY BUT WAS WITHOUT ASCITES ON THE REPORTING PHYSICIAN'S IMAGING PROCEDURE OVER 3 MONTHS. THE PATIENT WAS NOT TAKING CONCOMITANT MEDICATIONS. ON (B)(6) 2016, THE PATIENT RECEIVED 5.942 GBQ OF THERASPHERE YTTRIUM-90 GLASS MICROSPHERES (LOT NUMBER 1699201, VIAL 105 AND UNKNOWN EXPIRATION DATE) ADMINISTERED TO THE RIGHT HEPATIC ARTERY AS ONE TIME DELIVERY FOR HCC. ON (B)(6) 2016, AFTER TREATMENT WITH THERASPHERE, THE PATIENT'S LABORATORY VALUES WERE: TOTAL BILIRUBIN 1.1 AND ALKALINE PHOSPHATASE 138. THE PATIENT INITIALLY DID WELL WITH Y90 TREATMENT; HOWEVER, ON AN UNSPECIFIED DATE IN (B)(6) 2016, ABOUT ONE WEEK AFTER THE TREATMENT, THE PATIENT DEVELOPED ABDOMINAL DISTENSION AND DISCOMFORT AND WAS FOUND TO HAVE MODERATE ASCITES. THE PATIENT ALSO EXPERIENCED CONCOMITANT CACHEXIA WITH WEIGHT GAIN. THE REPORTING PHYSICIAN STATED THAT TIME PERIOD WAS TOO RAPID FOR RADIOEMBOLIZATION-INDUCED LIVER DISEASE (REILD), BUT THE PATIENT WAS PRESUMED TO HAVE BEEN PUSHED INTO A DECOMPENSATED STATE FROM THE MINOR TRANSIENT STRESS TO THE LIVER FROM THE PROCEDURE AND INFLAMMATION. AS SUCH, HE WAS PRESCRIBED WITH STEROIDS AND URSODIOL TO PREVENT REILD BECAUSE OF AN INFILTRATIVE DISEASE. ON (B)(6) 2016, THE PATIENT'S LABORATORY VALUES WERE: TOTAL BILIRUBIN 1.4, ALKALINE PHOSPHATASE 120 AND ALPHA 1 FOETOPROTEIN 192. ON (B)(6) 2016, THE PATIENT'S TOTAL BILIRUBIN WAS 1.9 AND HIS ALKALINE PHOSPHATASE WAS 129. THE PATIENT'S DECOMPENSATED STATE DID NOT IMPROVE OVER THE FOLLOWING WEEKS, AND ON (B)(6) 2016, APPROXIMATELY 1.25 MONTHS AFTER THE TREATMENT WITH THERASPHERE, THE PATIENT DIED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS NOT REPORTED. THE OUTCOME OF THE EVENTS INFILTRATIVE DISEASE, ASCITES, ABDOMINAL DISTENSION, ABDOMINAL DISCOMFORT, CACHEXIA AND WEIGHT GAIN WAS UNKNOWN. THE PHYSICIAN DID NOT ASSESS THE SERIOUSNESS OF THE EVENTS, BUT CONSIDERED THE ASCITES TO BE UNRELATED TO THE USE OF THE THERASPHERE. THE PHYSICIAN DID NOT PROVIDE AN ASSESSMENT OF THE OTHER EVENTS RELATEDNESS TO THE ADMINISTRATION OF THE THERASPHERE. THE COMPANY CONSIDERED THE EVENT HEPATIC DECOMPENSATION, INFILTRATIVE DISEASE, CACHEXIA AND ASCITES AS SERIOUS (FATAL, MEDICALLY SIGNIFICANT) AND THE EVENTS ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION AND WEIGHT INCREASED AS NON-SERIOUS. FOLLOW-UP INFORMATION WILL BE REQUESTED. FOLLOW-UP INFORMATION RECEIVED ON 15-NOV-2016: FOLLOW-UP INFORMATION FROM THE REPORTER CONFIRMED ADDITIONAL INFORMATION REGARDING THE PATIENT'S MEDICAL HISTORY, THE EVENTS AND CAUSALITY WITH THERASPHERE. THE PATIENT HAD ADDITIONAL MEDICAL HISTORY OF MILD CHRONIC INFLAMMATION OF LIVER FROM HCC AND ALCOHOLIC CIRRHOSIS. ON AN UNKNOWN DATE, AFTER THE TREATMENT WITH THERASPHERE, THE PATIENT EXPERIENCED TRANSIENT HEPATITIS FROM RADIOEMBOLIZATION AND SLOWLY PROGRESSED HCC WHICH EVOLVED TO A MULTIFOCAL, MULTICENTRIC HCC. THE SYMPTOMS OF THE DISEASE PROGRESSION (ASCITES, ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION, CACHEXIA AND WEIGHT GAIN) WERE PRESENT UNTIL THE TIME OF DEATH. ON AN UNSPECIFIED DATE, REPORTED AS LIKELY THE THIRD WEEK OF (B)(6) 2016, THE PATIENT EXPERIENCED LIVER DECOMPENSATION. THE PHYSICIAN WAS INFORMED BY THE PATIENT'S MOTHER OF HIS DEATH. THE CAUSE OF DEATH WAS UNKNOWN, HOWEVER IT WAS SUSPECTED BY THE REPORTER THAT THE PATIENT'S LIVER DECOMPENSATION THAT LED TO HIS DEATH WAS FROM THE NATURAL HISTORY OF HIS HCC AND ALCOHOLIC CIRRHOSIS. THE REPORTER DID NOT KNOW IF AN AUTOPSY WAS PERFORMED. THE PHYSICIAN CONSIDERED ASCITES, ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION, CACHEXIA AND WEIGHT GAIN ALL SYMPTOMS OF WORSENING LIVER FUNCTION, PRESUMABLY RELATED TO PROGRESSION OF HCC AND/OR CIRRHOSIS. ADDITIONALLY, THE PHYSICIAN STATED THAT THE EXACT CAUSE OF THE LIVER DECOMPENSATION WAS UNKNOWN AND THE RELATION WITH THERASPHERE WAS UNCERTAIN. THE MILD HEPATITIS FROM ANY INTRA-ARTERIAL LIVER PROCEDURE WAS NOT EXPECTED TO CAUSE HEPATIC FAILURE AND SUCH DECOMPENSATION. AS SUCH, IT WAS SUSPECTED THAT THE PATIENT'S LIVER DECOMPENSATION THAT LEAD TO HIS DEATH WAS FROM THE NATURAL HISTORY OF HIS HCC AND ALCOHOLIC CIRRHOSIS, THE SEVERITY OF WHICH WAS NOT REVEALED BY THE LABORATORY AND IMAGIOLOGICAL TESTS PERFORMED. THE COMPANY CONSIDERED THE EVENTS SLOWLY PROGRESSED HCC, LIVER DECOMPENSATION AND TRANSIENT HEPATITIS FROM RADIOEMBOLIZATION AS SERIOUS (FATAL, MEDICALLY SIGNIFICANT). THE PREVIOUSLY REPORTED EVENTS OF CACHEXIA, ASCITES, ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION AND WEIGHT GAIN WERE SUBSUMED UNDER THE EVENT OF LIVER DECOMPENSATION AS THESE ARE ALL SYMPTOMS OF LIVER DECOMPENSATION. THE PREVIOUSLY REPORTED EVENT INFILTRATIVE DISEASE WAS AMENDED TO THE EVENT SLOWLY PROGRESSED HCC AS PER REPORTED FOLLOW-UP INFORMATION. NO FURTHER INFORMATION IS EXPECTED. THIS REPORT IS FINAL. COMPANY COMMENT: DISEASE PROGRESSION IS CONSIDERED UNLISTED, WHEREAS THE EVENTS HEPATIC FAILURE AND RADIATION HEPATITIS ARE CONSIDERED LISTED ACCORDING TO THERASPHERE CURRENT REFERENCE SAFETY INFORMATION. IN AGREEMENT WITH THE PHYSICIAN'S ASSESSMENT, THE COMPANY CONSIDERED THE EVENT OF LIVER DECOMPENSATION AS UNLIKELY RELATED TO THE TREATMENT AND THE EVENT RADIATION HEPATITIS AS RELATED TO THERASPHERE. FURTHERMORE, IN AGREEMENT WITH THE PHYSICIAN'S ASSESSMENT, THE COMPANY ALSO CONSIDERED THE EVENT DISEASE PROGRESSION AS NOT RELATED TO THERASPHERE, BUT DUE TO GENERAL CONDITION OF THE PATIENT WHO HAD PROGRESSIVE DISEASE AND INFILTRATIVE DISEASE. NO EVIDENCE TO SUGGEST THERE WAS MALFUNCTION OF DEVICE. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF THERASPHERE. THE COMPANY IS CONTINUOUSLY MONITORING ALL RESPECTIVE REPORTS RECEIVED AND, BASED ON CUMULATIVE EXPERIENCE, WILL REEVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756129 THERASPHERE SINGLE USE IMPLANTABLE MEDICAL DEVICE NAW BIOCOMPATIBLES UK LTD 1699265

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death