TheraSphere Y90 Glass Microspheres 3 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05060116920284), received between Sep 18, 2017 and Aug 28, 2025 — classified as 5 deaths, 14 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEPATIC DYSFUNCTION POST THERASPHERE ADMINISTRATION. A THERASPHERE Y-90 (3.0 GBQ) DOSE VIAL AND A THERASPHERE Y-90 (3.5 GBQ) WAS SELECTED FOR USE IN THE RADIOEMBOLIZATION PROCEDURE. THE PATIENT WAS BEING TREATED FOR HEPATOCELLULAR CARCINOMA (HCC). THIS WAS A BILOBAR TREATMENT. THE WAS NOTED TO BE MULTIFOCAL WITH A TOTAL TUMOR VOLUME OF 29.3ML. THERE WAS NOTHING UNUSUAL OBSERVED DURING DEVICE PREPARATION OR THE THERASPHERE PROCEDURE. FOLLOWING THERASPHERE ADMINISTRATION, LIVER FUNCTION TESTS (LFTS) REVEALED THAT THE PATIENT WAS EXPERIENCING HEPATIC DYSFUNCTION. AS A RESULT, THE PATIENT WAS ADMINISTERED REILD PROPHYLAXIS (PREDNISOLONE 10 MG/D, UDC 500 MG BID, LWH). THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 22917389 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ROWAN CLINICAL STUDY. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED VOMITING REQUIRING PRESCRIPTION MEDICATION. ON (B)(6) 2024 TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER SELECTIVE THROUGH THE FEMORAL ARTERY. THREE DOSE VIALS WERE ADMINISTERED. TOTAL ADMINISTERED ACTIVITY WAS 4.29 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y-90 ON TUMORS. LUNG DOSE CALCULATION WAS 8.6 GY. ON (B)(6) 2024 ONE DAY POST THERASPHERE ADMINISTRATION, THE SUBJECT EXPERIENCED VOMITING. THE EVENT WAS TREATED WITH LEVOGASTROL (25MG/ DAILY). IT WAS FURTHER REPORTED THAT THE VOMITING RESOLVED ON (B)(6) 2024.

  Patient problems: Vomiting

  MAUDE report 20738763 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ROWAN CLINICAL STUDY. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED VOMITING REQUIRING PRESCRIPTION MEDICATION. ON (B)(6) 2024, TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER SELECTIVE THROUGH THE FEMORAL ARTERY. THREE DOSE VIALS WERE ADMINISTERED. TOTAL ADMINISTERED ACTIVITY WAS 4.29 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y-90 ON TUMORS. LUNG DOSE CALCULATION WAS 8.6 GY. ON (B)(6) 2024, ONE DAY POST THERASPHERE ADMINISTRATION, THE SUBJECT EXPERIENCED VOMITING. THE EVENT WAS TREATED WITH LEVOGASTROL (25MG/ DAILY). IT WAS FURTHER REPORTED THAT THE VOMITING RESOLVED ON (B)(6) 2024.

  Patient problems: Vomiting

  MAUDE report 20737959 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROACTIF (B)(4). IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AS A RESULT OF INTENSE FATIGUE. STANDARD, SINGLE COMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT MAA DOSIMETRY DOCUMENTED, DOSE TO TOTAL PERFUSED LIVER WAS 119.8 GY AND DOSE TO TOTAL PERFUSED TUMOR WAS 409.8 GY. ON (B)(6) 2020, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION FOR VIAL 1 WAS RIGHT LIVER. THE CATHETER WAS POSITIONED IN THE RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII): 2.677 GBQ OF THERASPHERE WAS ADMINISTERED TO THE RIGHT LIVER THROUGH VIAL 1. POST TREATMENT DOSIMETRY RESULTS WERE NOT DETERMINED. ON (B)(6)2020, 13 DAYS POST INDEX PROCEDURE THE SUBJECT EXPERIENCED INTENSE FATIGUE. ON THE SAME DAY, THE SUBJECT WAS ADMITTED IN THE HOSPITAL FOR THE FURTHER TREATMENT AND EVALUATION. ON (B)(6)2020, DURING HOSPITALIZATION, ECOG SCORE WAS ASSESSED AS 1. ENCEPHALOPATHY AND ASCITES SCORE WERE ASSESSED AS 0. CONCOMITANT MEDICATION WAS ADMINISTRATED TO TREAT THE EVENT. ON (B)(6)2020, THE EVENT WAS CONSIDERED RESOLVED AND ON THE SAME DAY SUBJECT WAS DISCHARGED FROM TH

  Patient problems: Fatigue; Muscle Weakness/Atrophy

  MAUDE report 17882486 ↗
• DeathNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MEETING ABSTRACT TITLED: "YTTRIUM-90 GLASS MICROSPHERE TRANSARTERIAL RADIOEMBOLIZATION FOR PATIENTS WITH UNRESECTABLE LIVER-DOMINANT BREAST CANCER METASTASIS " BY RISHI ET AL. DESCRIBED THE RESULTS OF A SINGLE-CENTRE, RETROSPECTIVE REVIEW OF 32 BREAST CANCER PATIENTS TREATED WITH THERASPHERE FOR LIVER-METASTASES. ADVERSE EVENTS WERE CLASSIFIED USING THE CTCAE CLASSIFICATION SYSTEM (V5.0). THE ARTICLE REPORTED PAIN (2 PATIENTS) AND WORSENING LIVER-FUNCTION (1 PATIENT). ONE ADDITIONAL PATIENT DIED FROM RADIOEMBOLIZATION-INDUCED LIVER DISEASE WITHIN 30 DAYS OF THERASPHERE TREATMENT.

  Patient problems: Liver Failure; Pain; Radiation Sickness Syndrome

  MAUDE report 10908797 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE TITLED, 'COMBINATION OF 1ST AND 2ND WEEK DOSING OF GLASS YTTRIUM-90 MICROSPHERES FOR SUPERSELECTIVE RADIOEMBOLIZATION' BY KIM ET AL., DESCRIBED THE RESULTS OF A SINGLE-CENTRE, RETROSPECTIVE REVIEW OF 53 PATIENTS TREATED WITH THERASPHERE FOR HEPATOCELLULAR CARCINOMA (HCC). THE STUDY COMPARED 32 PATIENTS WHO RECEIVED OF ONE VIAL THERASPHERE TO 21 PATIENTS WHO RECEIVED TWO VIALS (AT THE 1ST AND 2ND WEEK) OF THERASPHERE. ADVERSE EVENTS WERE CLASSIFIED USING THE CTCAE CLASSIFICATION SYSTEM (V5.0). THE ARTICLE REPORTED 4 CASES OF GRADE 3 BENIGN BILIARY STRICTURE. GRADE 3 BILE DUCT STENOSIS IS INDICATED IN CTCAE V5.0 AS REQUIRING SIGNIFICANT INTERVENTION TO PRECLUDE PERMANENT DAMAGE, MEETING THE CRITERIA OF A SERIOUS INJURY. THE ARTICLE ALSO REPORTED A DEATH 9 WEEKS AFTER RADIOEMBOLIZATION, THOUGH THIS WAS RELATED TO A PNEUMOCYSTITIS PNEUMONIA INFECTION. THE ARTICLE SUMMARISED CLINICAL ADVERSE EVENTS IN BOTH GROUPS, WITH THE FOLLOWING REPORTED ADVERSE EVENTS AS GRADE 3: GRADE 3: ABSCESS = 1/52; BENIGN BILIARY STRICTURE = 4/52; ASCITES = 1/52. GRADE 5: PNEUMOCYSTITIS PNEUMONIA = 1/52.

  Patient problems: Abscess; Ascites; Respiratory Tract Infection; Unspecified Hepatic or Biliary Problem

  MAUDE report 10908619 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS ADMITTED WITH PNEUMONITIS AFTER TREATMENT WITH THERASPHERE ON THE (B)(6)2020. THE PATIENT WAS TREATED WITH 2 THERASPHERE VIALS, WITH AN ABSORBED DOSE OF 131GY TO THE TARGET VOLUME. THE ABSORBED DOSE TO THE LUNGS WAS 10.9GY. THE REPORTING PHYSICIAN WAS NOT MADE AWARE OF THE DATE OF ADMISSION AND WAS SOLELY INFORMED OF THE PATIENT'S HOSPITALISATION. THE DATE RANGE OF THE PNEUMONITIS PRESENTATION AND HOSPITALISATION CAN RANGE FROM THE DAY OF THERASPHERE TREATMENT (B)(6) TO THE DATE THE REPORTER AND MANUFACTURER BECAME AWARE (B)(6). THE RELATIONSHIP BETWEEN THE PNEUMONITIS AND THE THERASPHERE TREATMENT WAS NOT STATED, BUT IS ASSUMED POSSIBLY RELATED AS THE EVENT OCCURED 9 OR LESS DAYS FROM THERASPHERE TREATMENT.

  Patient problems: Inflammation

  MAUDE report 10730924 ↗
• DeathOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT (B)(6) WITH A SOLITARY NODULE IN THE LEFT LIVER RECEIVED THERASPHERE ON (B)(6) 2019. THE ABSORBED DOSE TO THE LIVER WAS 122GY. THE PATIENT PRESENTED WITH DARK RECTAL BLEEDING (GRADE 4) ON THE (B)(6) 2020 AND WAS HOSPITALIZED ON (B)(6) 2020. THE PATIENT DEVELOPED AN ENCEPHALOPATHIC COMA SECONDARY TO THE DIGESTIVE HEMORRHAGE, WHICH WAS EXACERBATED BY HYPOVOLEMIA OCCURING DURING DIURETIC TREATMENT. THIS WAS ATTRIBUTED TO THE ECTOPIC VARICOUS VEINS OF THE SMALL INTESTINE. THE PATIENT EMERGED FROM THE COMA ON (B)(6) 2020 WITH NO FURTHER RECURRENCE OF BLEEDING, AND THE EVENT RESOLVED ON (B)(6) 2020. THIS EVENT WAS ASSESSED AS PROBABLY RELATED TO THE THERASPHERE PROCEDURE. THE PATIENT RECEIVED TREATMENT FOR RECTAL BLEEDING, AND AGAIN PRESENTED WITH HEPATIC ENCEPHALOPATHY ON (B)(6) 2020, ALONG WITH ASCITES (GRADE 4) AND HYPERBILIRUBINEMIA (GRADE 4). PROFUSE ASCITIC DECOMPENSATION WAS ALSO OBSERVED, WITH ALL ADVERSE EVENTS ATTRIBUTED TO THE EVOLUTION OF THE HEPATIC DISEASE. THE SUBJECT DID NOT RECOVER FROM THE COMA AND DIED ON THE (B)(6) 2020. THE PHYSICIAN REPORTED THAT THE ENCEPHALOPATHY, RECTAL BLEEDING, ASCITES AND HYPERBILIRUBINEMIA WERE PROBABLY RELATED TO THE THERASPHERE PROC

  Patient problems: Ascites; Encephalopathy; Hemorrhage/Blood Loss/Bleeding; Hyperbilirubinemia

  MAUDE report 10659524 ↗
• DeathOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT: (B)(6), WITH AN INFILTRATIVE HCC TUMOUR IN THE RIGHT AND LEFT LIVER, WAS ENROLLED IN THE (B)(6) ON (B)(6) 2020. THE PATIENT WAS TREATED USING A SELECTIVE APPROACH WITH 2 VIALS. THE DELIVERED DOSE TO THE PERFUSED, AND WHOLE LIVER IS CURRENTLY UNDETERMINED. ON (B)(6) 2020, THE SUBJECT DEVELOPED EDEMATOUS ASCITES DECOMPENSATION, ASSESSED AS GRADE 3 ACCORDING TO THE CTCAE V5.0. THE RESOLUTION OF THE ADVERSE EVENT IS CURRENTLY UNKNOWN. THE ADVERSE EVENT WAS ASSESSED BY THE PHYSICIAN AS DEFINITELY RELATED TO THE PROCEDURE. THE EVENT WAS INITIALLY REPORTED AS AN ADVERSE EVENT, BUT NOT A SERIOUS ADVERSE EVENT, BUT REQUIRED A SURGICAL PROCEDURE, AND CONCOMITANT MEDICATION TO RESOLVE.

  Patient problems: Ascites; Liver Damage/Dysfunction; Swelling/ Edema

  MAUDE report 10659504 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT (B)(6) WITH A HCC TUMOUR IN SEGMENT VIII OF THE RIGHT LIVER WAS ENROLLED IN THE PROACTIF REGISTRY STUDY ON (B)(6) 2020. THE PATIENT RECEIVED THERASPHERE ADMINISTRATION ON THE SAME DAY TO THE RIGHT LIVER. THE PERFUSED LIVER VOLUME AND ABSORBED DOSE HAS NOT BEEN REPORTED. ON (B)(6) 2020 (45 DAYS POST THERASPHERE ADMINISTRATION), THE PATIENT PRESENTED WITH FEVER (38.2 C), ABDOMINAL PAIN AND COGNITIVE DISTURBANCE. THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT, AND WAS TREATED WITH ANTIBIOTICS AND SURGICAL INTERVENTION. THE PATIENT ALSO PRESENTED IN (B)(6) 2020 WITH ANOREXIA (GRADE 3), WHICH WAS ALSO ASSESSED TO BE RELATED TO THERASPHERE PROCEDURE, BUT NO ACTION WAS TAKEN TO RESOLVE THE ANOREXIA. THE PHYSICIAN ASSESSED THE ABDOMINAL PAIN AND COGNITIVE DISTURBANCE AS A GRADE 2 SERIOUS ADVERSE EVENT (AS DEFINED IN THE CTCAE V5.0 ADVERSE EVENT REPORTING GUIDELINE, AND AS PROBABLY RELATED TO THE THERASPHERE ADMINISTRATION PROCEDURE.

  Patient problems: Abdominal Pain; Cognitive Changes

  MAUDE report 10659499 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS (B)(6) YEAR OLD MALE PATIENT WITH HCC EXPERIENCED ENCEPHALOPATHY AND DIGESTIVE HEMORRHAGE FOLLOWING TREATMENT WITH THERASPHERE. THE EVENT LED TO HOSPITALIZATION. THE PATIENT SUBJECT (B)(6) PARTICIPATED IN A RETROSPECTIVE STUDY OF THERASPHERE TREATMENT FOR HCC, THE TARGET TRIAL. THE PATIENT HAD A HISTORY OF CIRRHOSIS DUE TO ALCOHOL ABUSE AND CHRONIC BRONCHITIS AND INCREASED GGT LEVELS. THE PATIENT WAS DIAGNOSED WITH HCC RIGHT LOBE DISEASE IN (B)(6) 2014. BEFORE THERASPHERE TREATMENT, THE PATIENT HAD AN ECOG SCORE OF 0, LIVER FUNCTION WAS CHILD-PUGH CLASS B7 AND HCC STAGING WAS BCLC C. THE PATIENT HAD PORTAL HYPERTENSION WITH SPLENOMEGALY NOTED AT BASELINE. THE PATIENT HAD NO DISEASE RELATED SURGERY AND WAS NOT TREATED WITH SORAFENIB BEFORE THERASPHERE TREATMENT. ALBUMIN, PLATELET COUNT AND HEMOGLOBIN VALUES WERE LOWER THAN NORMAL. GGT, ALP, AAT, AFP AND CREATININE WERE ELEVATED AT BASELINE. ALBUMIN (26 G/L) WAS BELOW THE LOWER REFERENCE RANGE. LABS COLLECTED AT BASELINE ALTHOUGH OUTSIDE OF THE GIVEN REFERENCE RANGES WERE NOT CONTRAINDICATIONS TO THE PROTOCOL. THE PATIENT WAS ADMINISTERED THERASPHERE ON (B)(6) 2015. ACTIVITY WAS 2.79 GBQ AND LUNG SHUNTING WAS 5.2%. THE TOTAL VOL

  Patient problems: Encephalopathy; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9872169 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: 24-AUG-2019. AS A FOLLOW-UP ON THE CASE: DR. MAHVASH RETURNED FROM HIS LEAVE AND WE RECEIVED FINAL INFORMATION ON PATIENT (B)(6). "REGARDING PT (B)(6): FATIGUE WAS DETERMINED TO BE UNRELATED TO THERASPHERE. IT WAS ATTRIBUTED TO CONCOMITANT COMBINATION OF DISEASE AND OTHER COMPLICATIONS.

  Patient problems: Abdominal Pain; Death; Fatigue; No Code Available; Pneumonia; Sepsis

  MAUDE report 8891885 ↗
• InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AUTO-NOTIFICATION RECEIVED FROM DATATRAK 28-JUN-2019. SUBJECT (B)(6) ENROLLED ON THE (B)(6) STUDY IS A (B)(6) MALE PATIENT DIAGNOSED WITH HCC ON (B)(6) 2015; UNILOBAR DISEASE (RIGHT LIVER LOBE). PORTAL HYPERTENSION - NOT PRESENT. ETIOLOGIC ASSOCIATIONS: LIVER CIRRHOSIS, (B)(6), NO PRIOR SORAFENIB TREATMENT BEFORE THERASPHERE TREATMENT, BASELINE BCLC STAGE: B, NO PREVIOUS HCC SURGERY, BASELINE ALBUMIN NOT DOCUMENTED, BILIRUBINE 2.5 MG/DL. THERASPHERE TREATMENT: (B)(6) 2016. ACTIVITY RECORDED AS START OF INFUSION: 2.923 GBQ. RESIDUALS REMAINS IN DELIVERY SET: 0.01 GBQ. LUNG SHUNT FRACTION 5.1%. ON (B)(6) 2016 PATIENT PRESENTED WITH ASCITES (GRADE 3). IT WAS REPORTED THE PATIENT IS RECEIVE PARACENTESIS TO REMOVE FLUID. PATIENT WAS HOSPITALIZED (UNKNOWN ADMISSION/DISCHARGE DATES). OUTCOME: RECOVERING/RESOLVING. ADDITIONAL INFORMATION RECEIVED 08-JUL-2019: REPORTER CONFIRMED: PATIENT DID DEVELOP ASCITES AFTER THE Y90. HE HAD A SMALL AMOUNT NOT WARRANTING TREATMENT SEEN ON THE (B)(6) 2016 CT. HE HAD A LOT OF ASCITES ON THE (B)(6) 2016 CT, AND HAD A 5600 ML PARACENTESIS ON (B)(6) 2016 (THAT APPEARS TO HAVE BEEN HIS FIRST PARA). HIS TOTAL BILIRUBIN ON (B)(6) WAS, SURPRISINGLY, DOWN TO 1.7

  Patient problems: Ascites

  MAUDE report 8784528 ↗
• InjuryJun 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). SUBJECT: (B)(6). LAST SAE REPORT: 21 MAY 2019. SAE: HEPATIC FAILURE (HEPATIC FAILURE). THIS REPORT CONCERNS SUBJECT (B)(6), A FEMALE SUBJECT BORN IN (B)(6), WHO WAS ENROLLED IN STUDY TS-102 ENTITLED "A PHASE III CLINICAL TRIAL EVALUATING THERASPHERE® IN SUBJECTS WITH METASTATIC COLORECTAL CARCINOMA OF THE LIVER WHO HAVE FAILED FIRST LINE CHEMOTHERAPY". ON (B)(6) 2018, THE SUBJECT WAS RANDOMIZED TO RECEIVE TREATMENT WITH THERASPHERE® FOR METASTATIC COLORECTAL CARCINOMA AND SECOND-LINE CHEMOTHERAPY. ON (B)(6) 2018, THE SUBJECT RECEIVED FIRST CYCLE OF SECOND-LINE CHEMOTHERAPY, FOLFOX REGIMEN (OXALIPLATIN 154.77 MG INTRAVENOUS (IV), FOLINIC ACID 364.16 MG IV WHICH COMPLETED ON (B)(6) 2018 AND FLUOROURACIL 3641.6 MG IV WHICH COMPLETED ON 01 NOV 2018). ON (B)(6) 2018, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 2 VIALS OF THERASPHERE®. THE RIGHT HEPATIC LOBE WAS TREATED WITH 1 VIAL (LOT NO 1899525, EXPIRY DATE: 30 NOV 2018) AT A DOSE OF 113.56 GY. ONE VIAL WAS ADMINISTERED IN THE LEFT HEPATIC LOBE (LOT NO 1899525, EXPIRY DATE: 30 NOV 2018) AT A DOSE OF 113.56 GY. ON (B)(6) 2019, THE SUBJECT RECEIVED MOST RECENT CYCLE (NINTH) OF SECOND-LINE CHEMOTHERAPY, FOLFOX REGIMEN (OXALIPLATIN

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 8662456 ↗
• DeathMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: 23-JUN-2019. ADMINISTERED ACTIVITY: 3.01GBQ, TOTAL PERFUSED VOLUME: 1107.3MM3 TREATMENT WAS ADMINISTERED THROUGH THE RIGHT HEPATIC ARTERY TO THE RIGHT LOBE OF THE LIVER. ADDITIONAL INFORMATION RECEIVED: 28-JUN-2019. PHYSICIAN REPORTED: I REVIEWED THE ORIGINAL ACTIVITY CALCULATION SHEETS, AND THE SEGMENT 2/4 ARTERY AND THE SEGMENT 3 ARTERY WERE PRESCRIBED 117 GY EACH. PART OF SEG 4 WAS FED BY COLLATERAL FLOW FROM THE RIGHT LOBE, SO IT IS POSSIBLE THAT THE 2/4 VOLUME OF DISTRIBUTION WAS SMALLER THAN ANTICIPATED AND THE ABSORBED DOSE WAS HIGHER. I WILL NEED TO CHECK THE SEGMENTATION BY THE DR TO SEE WHETHER IT DIFFERS FROM THE ORIGINAL SEGMENTATION USED FOR ACTIVITY CALCULATION.

  Patient problems: Death; Liver Damage/Dysfunction; Patient Problem/Medical Problem; Renal Failure; Sepsis; Unspecified Infection

  MAUDE report 8648764 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  2 THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT; IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THIS SERIOUS ADVERSE EVENT. REFER TO MDR 3002124543-2019-00001 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. (B)(4). SUBJECT: (B)(6). LAST SAE REPORT: 24 JAN 2019. SAE: THROMBOCYTOPENIA. THIS REPORT CONCERNS SUBJECT (B)(6), A FEMALE SUBJECT BORN IN (B)(6), WHO WAS ENROLLED IN STUDY (B)(6) ENTITLED "(B)(6)". ON (B)(6) 2018, THE SUBJECT WAS RANDOMIZED TO RECEIVE TREATMENT WITH THERASPHERE® FOR METASTATIC COLORECTAL CARCINOMA AND SECOND-LINE CHEMOTHERAPY. ON (B)(6) 2018, THE SUBJECT RECEIVED THE FIRST CYCLE OF SECOND-LINE CHEMOTHERAPY, FOLFOX REGIMEN (OXALIPLATIN 151.3 MG, FOLINIC ACID 178 MG AND FLUOROURACIL 1780 MG WHICH COMPLETED ON (B)(6) 2018). ON (B)(6) 2018, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 2 VIALS OF THERASPHERE®. THE RIGHT HEPATIC LOBE WAS TREATED WITH 1 VIAL (DOSE: 114 GY, ACTIVITY OF 7 GBQ, LOT NO 1899441, EXPIRY DATE: 12 OCT 2018). ONE VIAL WAS ADMINISTERED IN THE LEFT HEPATIC LOBE (DOSE: 117 GY, VIAL ACTIVITY OF 3 GBQ/LOT NO 1899441, EXPIRY DATE: 12 OCT 2018). ON (B)(6) 2018, THE SUBJECT RECEIVED THE MOST RECENT CYCLE (FOURTH) OF SECOND-LINE CHEMOTHERAPY,

  Patient problems: No Code Available

  MAUDE report 8304060 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  2 THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THIS SERIOUS ADVERSE EVENT. REFER TO MDR 3002124543-2019-00001 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. MFR REPORT NUMBER: 3002124543-2019-00002. (B)(4). LAST SAE REPORT: 24 JAN 2019. SAE: THROMBOCYTOPENIA. THIS REPORT CONCERNS SUBJECT (B)(6), A FEMALE SUBJECT BORN IN (B)(6), WHO WAS ENROLLED IN STUDY (B)(6) IN SUBJECTS WITH METASTATIC COLORECTAL CARCINOMA OF THE LIVER WHO HAVE FAILED FIRST LINE CHEMOTHERAPY". ON (B)(6) 2018, THE SUBJECT WAS RANDOMIZED TO RECEIVE TREATMENT WITH THERASPHERE® FOR METASTATIC COLORECTAL CARCINOMA AND SECOND-LINE CHEMOTHERAPY. ON (B)(6) 2018, THE SUBJECT RECEIVED THE FIRST CYCLE OF SECOND-LINE CHEMOTHERAPY, FOLFOX REGIMEN (OXALIPLATIN 151.3 MG, FOLINIC ACID 178 MG AND FLUOROURACIL 1780 MG WHICH COMPLETED ON (B)(6) 2018). ON (B)(6) 2018, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 2 VIALS OF THERASPHERE®. THE RIGHT HEPATIC LOBE WAS TREATED WITH 1 VIAL (DOSE: 114 GY, ACTIVITY OF 7 GBQ, LOT NO 1899441, EXPIRY DATE: 12 OCT 2018). ONE VIAL WAS ADMINISTERED IN THE LEFT HEPATIC LOBE (DOSE: 117 GY, VIAL ACTIVITY OF 3 GBQ/LOT NO 1899441, EXPIRY DATE: 1

  Patient problems: No Code Available

  MAUDE report 8304012 ↗
• InjurySep 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SENT TO UPDATE SAES VERBATIM TERMS, SAES EXPECTEDNESS AND SAES ASSESSMENTS. THIS CASE IS NO LONGER CONSIDERED AS USADE. MFR # 3002124543-2017-00042. INTERNAL MCN: (B)(4). SUBJECT NUMBER: (B)(4). LAST SIGNIFICANT SAE REPORT: 16 NOV 2017. SAE: RADIATION PNEUMONITIS (RADIATION PNEUMONITIS); DEHYDRATION (DEHYDRATION). THE REPORTER HAS UPDATED SAE TERMS TO RADIATION PNEUMONITIS AND DEHYDRATION WHICH ARE BOTH EXPECTED EVENTS AS PER INVESTIGATORS BROCHURE. ON 12 JUL 2017, THE SUBJECT RECOVERED WITH SEQUELAE FROM THEN EVENTS OF RADIATION PNEUMONITIS AND DEHYDRATION. ACTION TAKEN WITH SUBJECT PARTICIPATION IN THE STUDY HAS NOT BEEN REPORTED. THE INVESTIGATOR ASSESSED THE EVENT OF RADIATION PNEUMONITIS AS GRADE-3 (SEVERE) IN INTENSITY, SERIOUS DUE TO HOSPITALIZATION AND AS POSSIBLY RELATED STUDY DEVICE, STUDY PROCEDURE AND STUDY TREATMENT (SECOND-LINE CHEMOTHERAPY). THE INVESTIGATOR ASSESSED THE EVENT OF DEHYDRATION AS GRADE-3 (SEVERE) IN INTENSITY, SERIOUS DUE TO HOSPITALIZATION AND RELATED TO DISEASE UNDER STUDY. THE EVENT WAS NOT RELATED STUDY DEVICE, STUDY PROCEDURE AND STUDY TREATMENT (SECOND-LINE CHEMOTHERAPY). THE COMPANY AGREED WITH THE INVESTIGATOR'S A

  Patient problems: Dehydration; Hypoxia; Radiation Exposure, Unintended; Respiratory Failure

  MAUDE report 6885690 ↗
• DeathSep 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). (B)(6). LAST SIGNIFICANT SAE REPORT: (B)(6) 2017. SAE: RADIOEMBOLIZATION INDUCED LIVER DISEASE (REILD) (RADIATION HEPATITIS). THIS REPORT CONCERNS SUBJECT (B)(6), A FEMALE (B)(6), WHO WAS ENROLLED IN STUDY (B)(6) ENTITLED "A PHASE III CLINICAL TRIAL EVALUATING THERASPHERE® IN SUBJECTS WITH METASTATIC COLORECTAL CARCINOMA OF THE LIVER WHO HAVE FAILED FIRST LINE CHEMOTHERAPY". THE SUBJECT RECEIVED THERASPHERE® 125.9 GY TO THE LEFT LOBE AND 131.7 GY TO THE RIGHT LOBE ON (B)(6) 2016. THE SUBJECT STARTED TREATMENT WITH SECOND-LINE CHEMOTHERAPY FOR METASTATIC COLORECTAL CARCINOMA ON (B)(6) 2016; FOLFIRI REGIMEN (IRINOTECAN 240 MG IV, FOLINIC ACID 350 MG IV AND FLUOROURACIL 4450 MG IV). THE SUBJECT TOOK THE FOURTH CYCLE OF SECOND-LINE CHEMOTHERAPY ON (B)(6) 2016. THE SUBJECT HAD NO RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE NOT REPORTED AT THE TIME OF THIS REPORT. ON (B)(6) 2016, (B)(6) 2017, THE SUBJECT'S ALT RESULT WAS 15 IU/L (NORMAL 5 - 45), 18 IU/L (NORMAL 5 - 45), 27 IU/L (NORMAL 5 - 45), 33 IU/L (NORMAL 5 - 45), 44 IU/L (NORMAL 5 - 45) AND 59 IU/L (NORMAL 10 - 49) RESPECTIVELY. ON (B)(6) 2017, HER CT THORAX AND ABDOMEN REVEALED PARTIAL DISEASE RESPONSE, CHANGE

  Patient problems: Death; Liver Damage/Dysfunction

  MAUDE report 6871919 ↗