BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 5731932 · Received June 17, 2016

    Report

    Report Number
    3002124545-2016-00046
    Event Type
    Death
    Date Received
    June 17, 2016
    Date of Event
    May 28, 2013
    Report Date
    June 8, 2016
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DETERIORATION LIVER FUNCTION [HEPATIC FUNCTION ABNORMAL]. POSSIBLY ALSO TUMOR PROGRESSION [NEOPLASM PROGRESSION]. CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 08-JUN-2016: THIS LITERATURE CASE REPORT WAS PUBLISHED IN 2016 IN THE HPB (THE OFFICIAL JOURNAL OF THE INTERNATIONAL HEPATO PANCREATO BILIARY ASSOCIATION) ELECTRONIC POSTER ABSTRACTS BY LIEFHOOGHE ET AL. WITH THE TITLE "OUTCOMES OF THERASPHERE RADIOEMBOLIZATION FOR COLORECTAL METASTASES AND HEPATOCELLULAR CANCER: A SINGLE CENTER EXPERIENCE." AND IT CONCERNED A (B)(6) MALE PATIENT. PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON(B)(6) 2013, THE PATIENT UNDERWENT RADIOEMBOLIZATION WITH THERASPHERE (YTTRIUM 90) (LOT/BATCH NUMBER AND EXPIRATION DATE UNKNOWN), FOR MULTIFOCAL HEPATOCELLULAR CARCINOMA (HCC). THE PATIENT RECEIVED 106 GY IN THE RIGHT LIVER LOBE AND 109 GY IN THE LEFT LIVER LOBE. ON (B)(6) 2013, 69 DAYS AFTER THE TREATMENT WITH THERASPHERE, THE PATIENT DEVELOPED DETERIORATION LIVER FUNCTION. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ASCITES AROUND LIVER AND POSSIBLY ALSO TUMOR PROGRESSION. ON (B)(6) 2013 THE EVENT DETERIORATION LIVER FUNCTION STOPPED. THE PATIENT DID NOT RECOVER FROM THE EVENT DETERIORATION LIVER FUNCTION. THE OUTCOME FOR ASCITES AROUND LIVER AND POSSIBLY TUMOR PROGRESSION WAS NOT REPORTED. THE REPORTER ASSESSED THE EVENT DETERIORATION LIVER FUNCTION TO BE LIFE THREATENING AND RELATED TO THE USE OF THERASPHERE. THE REPORTER DID NOT PROVIDE A SERIOUSNESS OR CAUSALITY ASSESSMENT FOR THE EVENTS ASCITES AROUND LIVER AND POSSIBLY TUMOR PROGRESSION. THE COMPANY ASSESSED THE EVENTS DETERIORATION LIVER FUNCTION, POSSIBLY TUMOR PROGRESSION AND ASCITES AROUND LIVER AS SERIOUS (LIFE THREATENING, MEDICALLY SIGNIFICANT). ADDITIONAL FOLLOW UP INFORMATION HAS BEEN SOUGHT. NEXT REPORT WILL BE SENT IN 30 DAYS. FOLLOW-UP INFORMATION RECEIVED ON 06-JUL-2016: THE PATIENT'S MEDICAL HISTORY INCLUDED CIRRHOSIS CHILD A, VARICES GRADE I, MULTIFOCAL HEPATOCELLULAR CARCINOMA, CLAVICULA FRACTURE (2008), TIBIA FRACTURE (2008), PELVIS LEFT FRACTURE (2008) AND COMMOTIO CEREBRI (2008). THE PATIENT RECEIVED NO CONCOMITANT MEDICATION. THE REPORTER CONSIDERED THE EVENT ASCITES AROUND LIVER A SYMPTOM OF THE LIVER FUNCTION DETERIORATION. THE PATIENT HAD NO ASCITES BEFORE AND SIGNIFICANT ASCITES 2 MONTHS AFTER THE PROCEDURE. ON AN UNKNOWN DATE THE OUTCOME OF ASCITES AROUND LIVER WAS NOT RESOLVED. THE OUTCOME OF THE EVENTS TUMOR PROGRESSION AND DETERIORATION LIVER FUNCTION WAS FATAL. ON (B)(6) 2013 THE PATIENT DIED OF LIVER FAILURE. THE REPORTER CONSIDERED TUMOR PROGRESSION AS NOT RELATED TO THE USE OF THERASPHERE. THE COMPANY ASSESSED THE EVENTS DETERIORATION LIVER FUNCTION AND POSSIBLY TUMOR PROGRESSION AS SERIOUS (FATAL, LIFE THREATENING, MEDICALLY SIGNIFICANT). NO DEVICE FAILURE HAS BEEN IDENTIFIED AS A RESULT OF THESE ADVERSE EVENTS. IT HAS BEEN ASSESSED THAT NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME AND THE REPORT IS CONSIDERED FINAL. CASE COMMENT: HEPATIC FUNCTION ABNORMAL AND NEOPLASM PROGRESSION ARE CONSIDERED UNLISTED AS PER THE CURRENT THERASPHERE INSTRUCTIONS FOR USE. THE REPORTER ASSESSED THE EVENT DETERIORATION LIVER FUNCTION AS RELATED AND THE EVENT POSSIBLY TUMOR PROGRESSION AS NOT RELATED TO THE USE OF THERASPHERE. IN AGREEMENT WITH THE REPORTER, THE COMPANY CONSIDERED THE EVENT DETERIORATION LIVER FUNCTION AS RELATED AND THE EVENT POSSIBLY TUMOR PROGRESSION AS NOT RELATED TO THERASPHERE. 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 RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS. THIS CASE IS LINKED WITH CASE (B)(4).

    Description of Event or Problem · 1

    DETERIORATION LIVER FUNCTION [HEPATIC FUNCTION ABNORMAL]. POSSIBLY ALSO TUMOR PROGRESSION [NEOPLASM PROGRESSION]. ASCITES AROUND LIVER [ASCITES] . CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 08-JUN-2016: THIS LITERATURE CASE REPORT WAS PUBLISHED IN 2016 IN THE HPB (THE OFFICIAL JOURNAL OF THE INTERNATIONAL HEPATO PANCREATO BILIARY ASSOCIATION) ELECTRONIC POSTER ABSTRACTS BY LIEFHOOGHE ET AL. WITH THE TITLE "OUTCOMES OF THERASPHERE RADIOEMBOLIZATION FOR COLORECTAL METASTASES AND HEPATOCELLULAR CANCER: A SINGLE CENTER EXPERIENCE." AND IT CONCERNED A (B)(6) MALE PATIENT. PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2013, THE PATIENT UNDERWENT RADIOEMBOLIZATION WITH THERASPHERE (YTTRIUM 90) (LOT/BATCH NUMBER AND EXPIRATION DATE UNKNOWN), FOR MULTIFOCAL HEPATOCELLULAR CARCINOMA (HCC). THE PATIENT RECEIVED 106 GY IN THE RIGHT LIVER LOBE AND 109 GY IN THE LEFT LIVER LOBE. ON (B)(6) 2013, 69 DAYS AFTER THE TREATMENT WITH THERASPHERE, THE PATIENT DEVELOPED DETERIORATION LIVER FUNCTION. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ASCITES AROUND LIVER AND POSSIBLY ALSO TUMOR PROGRESSION. ON (B)(6) 2013 THE EVENT DETERIORATION LIVER FUNCTION STOPPED. THE PATIENT DID NOT RECOVER FROM THE EVENT DETERIORATION LIVER FUNCTION. THE OUTCOME FOR ASCITES AROUND LIVER AND POSSIBLY TUMOR PROGRESSION WAS NOT REPORTED. THE REPORTER ASSESSED THE EVENT DETERIORATION LIVER FUNCTION TO BE LIFE THREATENING AND RELATED TO THE USE OF THERASPHERE. THE REPORTER DID NOT PROVIDE A SERIOUSNESS OR CAUSALITY ASSESSMENT FOR THE EVENTS ASCITES AROUND LIVER AND POSSIBLY TUMOR PROGRESSION. THE COMPANY ASSESSED THE EVENTS DETERIORATION LIVER FUNCTION, POSSIBLY TUMOR PROGRESSION AND ASCITES AROUND LIVER AS SERIOUS (LIFE THREATENING, MEDICALLY SIGNIFICANT). ADDITIONAL FOLLOW UP INFORMATION HAS BEEN SOUGHT. NEXT REPORT WILL BE SENT IN 30 DAYS. CASE COMMENT: HEPATIC FUNCTION ABNORMAL AND NEOPLASM PROGRESSION ARE CONSIDERED UNLISTED AS PER THE CURRENT THERASPHERE INSTRUCTIONS FOR USE. ASCITES IS CONSIDERED LISTED AS PER THE CURRENT THERASPHERE INSTRUCTIONS FOR USE. THE REPORTER ASSESSED THE EVENT DETERIORATION LIVER FUNCTION AS RELATED TO THE TREATMENT BUT DID NOT ASSESS THE EVENTS ASCITES AROUND LIVER AND POSSIBLY TUMOR PROGRESSION. ALTHOUGH LIMITED INFORMATION WAS PROVIDED BY THE REPORTER, THE COMPANY CONSIDERED ALL EVENTS EXPERIENCED BY THE PATIENT AS POSSIBLE RELATED TO THE THERASPHERE, SINCE ITS ROLE CANNOT BE RULED OUT. 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 RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS. THIS CASE IS LINKED WITH (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387468 THERASPHERE SINGLE USE IMPLANTABLE MEDICAL DEVICE NAW BIOCOMPATIBLES UK LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| L| O