TheraSphere Y90 Glass Microspheres 3.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05060116921373), received between Feb 7, 2024 and Aug 13, 2025 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD NAUSEA AND PAIN, REQUIRING PRESCRIPTION MEDICATION. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 8.7 %. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER WAS SELECTIVE (<=2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY AND 5 DOSE VIALS WERE ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS 5.21 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. LUNG DOSE CALCULATION WAS 22.7. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, MONOTHERAPY WITH 1500 MG DURVALUMAB WAS ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 1 DAY POST THE THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH NAUSEA, SHOULDER PAIN, RIGHT UPPER QUADRANT ABDOMINAL PAIN, CONSTIPATION, LOW GRADE FEVER, AND FATIGUE. THE NAUSEA WAS MEDICALLY TREATED WITH ONDANSETRON ODT (ZOFRAN-ODT) AND OLANZAPINE (ZYPREXA). SHOULDER AND AB

  Patient problems: Abdominal Pain; Constipation; Fatigue; Fever; Low White Blood Cell Count; Nausea; Pain

  MAUDE report 22800251 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD NAUSEA AND PAIN, REQUIRING PRESCRIPTION MEDICATION. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 8.7 %. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER WAS SELECTIVE (<=2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY AND 5 DOSE VIALS WERE ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS 5.21 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. LUNG DOSE CALCULATION WAS 22.7. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, MONOTHERAPY WITH 1500 MG DURVALUMAB WAS ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 1 DAY POST THE THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH NAUSEA, SHOULDER PAIN, RIGHT UPPER QUADRANT ABDOMINAL PAIN, CONSTIPATION, LOW GRADE FEVER, AND FATIGUE. THE NAUSEA WAS MEDICALLY TREATED WITH ONDANSETRON ODT (ZOFRAN-ODT) AND OLANZAPINE (ZYPREXA). SHOULDER AND AB

  Patient problems: Abdominal Pain; Constipation; Fatigue; Fever; Low White Blood Cell Count; Nausea; Pain

  MAUDE report 22800248 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD NAUSEA AND PAIN, REQUIRING PRESCRIPTION MEDICATION. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 8.7 %. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER WAS SELECTIVE (<=2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY AND 5 DOSE VIALS WERE ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS 5.21 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. LUNG DOSE CALCULATION WAS 22.7. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, MONOTHERAPY WITH 1500 MG DURVALUMAB WAS ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 1 DAY POST THE THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH NAUSEA, SHOULDER PAIN, RIGHT UPPER QUADRANT ABDOMINAL PAIN, CONSTIPATION, LOW GRADE FEVER, AND FATIGUE. THE NAUSEA WAS MEDICALLY TREATED WITH ONDANSETRON ODT (ZOFRAN-ODT) AND OLANZAPINE (ZYPREXA). SHOULDER AND AB

  Patient problems: Abdominal Pain; Constipation; Fatigue; Fever; Low White Blood Cell Count; Nausea; Pain

  MAUDE report 22800246 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD NAUSEA AND PAIN, REQUIRING PRESCRIPTION MEDICATION. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 8.7 %. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER WAS SELECTIVE (<=2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY AND 5 DOSE VIALS WERE ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS 5.21 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. LUNG DOSE CALCULATION WAS 22.7. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, MONOTHERAPY WITH 1500 MG DURVALUMAB WAS ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 1 DAY POST THE THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH NAUSEA, SHOULDER PAIN, RIGHT UPPER QUADRANT ABDOMINAL PAIN, CONSTIPATION, LOW GRADE FEVER, AND FATIGUE. THE NAUSEA WAS MEDICALLY TREATED WITH ONDANSETRON ODT (ZOFRAN-ODT) AND OLANZAPINE (ZYPREXA). SHOULDER AND AB

  Patient problems: Abdominal Pain; Constipation; Fatigue; Fever; Low White Blood Cell Count; Nausea; Pain

  MAUDE report 22800245 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD NAUSEA AND PAIN, REQUIRING PRESCRIPTION MEDICATION. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 8.7 %. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER WAS SELECTIVE (<=2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY AND 5 DOSE VIALS WERE ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS 5.21 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. LUNG DOSE CALCULATION WAS 22.7. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, MONOTHERAPY WITH 1500 MG DURVALUMAB WAS ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 1 DAY POST THE THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH NAUSEA, SHOULDER PAIN, RIGHT UPPER QUADRANT ABDOMINAL PAIN, CONSTIPATION, LOW GRADE FEVER, AND FATIGUE. THE NAUSEA WAS MEDICALLY TREATED WITH ONDANSETRON ODT (ZOFRAN-ODT) AND OLANZAPINE (ZYPREXA). SHOULDER AND AB

  Patient problems: Abdominal Pain; Constipation; Fatigue; Fever; Low White Blood Cell Count; Nausea; Pain

  MAUDE report 22800242 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ABDOMINAL PAIN, REQUIRING PRESCRIPTION MEDICATION. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2024. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS, DOSE TO PERFUSED LIVER WAS 400 GY; DOSE TO TOTAL NORMAL TISSUE WAS 20 GY. LUNG SHUNT CALCULATION WAS 17%. THERASPHERE TREATMENT ADMINISTRATION WAS PERFORMED ON (B)(6) 2024. THERASPHERE ADMINISTERED TO THE LIVER WAS MULTIPLE SELECTIVE THROUGH THE FEMORAL ARTERY AND TWO DOSE VIALS WERE ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS 1.611GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. DOSE TO PERFUSED LIVER WAS 1270 GY; DOSE TO TOTAL NORMAL TISSUE WAS 57 GY. LUNG DOSE CALCULATION WAS 0. ON (B)(6) 2024, SAME DAY POST INDEX PROCEDURE, SUBJECT WAS NOTED WITH ABDOMINAL PAIN THAT RADIATES TO BACK AND DYSPEPSIA. THE PAIN WAS TREATED MEDICALLY WITH OXYCODONE (5 MG/ORAL/AS NEEDED). DYSPEPSIA WAS TREATED WITH PANTOPRAZOLE. ON (B)(6) 2024, 40 DAYS POST INDEX PROCEDURE, SUBJECT WAS DIAGNOSED WITH ELEVATED GAMMA-GLUTAMYL TRANSFERASE (GGT). NO ACTION WAS TAKEN TO TREAT THIS EVENT.

  Patient problems: Abdominal Pain; Heartburn/Indigestion; Liver Damage/Dysfunction

  MAUDE report 21884072 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ABDOMINAL PAIN, REQUIRING PRESCRIPTION MEDICATION. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2024. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS, DOSE TO PERFUSED LIVER WAS 400 GY; DOSE TO TOTAL NORMAL TISSUE WAS 20 GY. LUNG SHUNT CALCULATION WAS 17%. THERASPHERE TREATMENT ADMINISTRATION WAS PERFORMED ON (B)(6) 2024. THERASPHERE ADMINISTERED TO THE LIVER WAS MULTIPLE SELECTIVE THROUGH THE FEMORAL ARTERY AND TWO DOSE VIALS WERE ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS 1.611GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. DOSE TO PERFUSED LIVER WAS 1270 GY; DOSE TO TOTAL NORMAL TISSUE WAS 57 GY. LUNG DOSE CALCULATION WAS 0. ON (B)(6) 2024, SAME DAY POST INDEX PROCEDURE, SUBJECT WAS NOTED WITH ABDOMINAL PAIN THAT RADIATES TO BACK AND DYSPEPSIA. THE PAIN WAS TREATED MEDICALLY WITH OXYCODONE (5 MG/ORAL/AS NEEDED). DYSPEPSIA WAS TREATED WITH PANTOPRAZOLE. ON (B)(6) 2024, 40 DAYS POST INDEX PROCEDURE, SUBJECT WAS DIAGNOSED WITH ELEVATED GAMMA-GLUTAMYL TRANSFERASE (GGT). NO ACTION WAS TAKEN TO TREAT THIS EVENT.

  Patient problems: Abdominal Pain; Heartburn/Indigestion; Liver Damage/Dysfunction

  MAUDE report 21884058 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SUBJECT EXPERIENCED ASCITES POST-ADMINISTRATION THAT WAS TREATED MEDICALLY. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2024. PRE-TREATMENT MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS, DOSE TO PERFUSED LIVER WAS 1465.4 GY; DOSE TO TOTAL NORMAL TISSUE WAS 62.9 GY. LUNG SHUNT CALCULATION WAS 3 PERCENT. THERASPHERE TREATMENT ADMINISTRATION WAS PERFORMED ON (B)(6) 2024 TO MULTIPLE SELECTIVE THROUGH THE FEMORAL ARTERY USING TWO DOSE VIALS. TOTAL ADMINISTERED ACTIVITY WAS 1.65 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. DOSE TO PERFUSED LIVER WAS 1433 GY AND DOSE TO TOTAL NORMAL TISSUE WAS 62.9 GY. LUNG DOSE CALCULATION WAS 2.4. ON (B)(6) 2024, 67 DAYS POST THE THERASPHERE ADMINISTRATION SUBJECT WAS NOTED WITH ASCITES. ON (B)(6) 2024, CHILD-PUGH SCORE WAS ASSESSED AS B (FUNCTIONAL COMPROMISE, WORSENING DISEASE) 7-9 POINTS. ON (B)(6) 2024, THE SUBJECT UNDERWENT PARACENTESIS TO RELIEVE ASCITES CAUSED BY DETERIORATING LIVER FUNCTION. ANOTHER PARACENTESIS WAS PERFORMED REVEALING AN INFECTION, AND ANTIBIOTICS WERE ADMINISTERED ACCORDINGLY. ASCITES WAS MEDICALLY MANAGED

  Patient problems: Ascites; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 21552495 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SUBJECT EXPERIENCED ASCITES POST-ADMINISTRATION THAT WAS TREATED MEDICALLY. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2024. PRE-TREATMENT MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS, DOSE TO PERFUSED LIVER WAS 1465.4 GY; DOSE TO TOTAL NORMAL TISSUE WAS 62.9 GY. LUNG SHUNT CALCULATION WAS 3 PERCENT. THERASPHERE TREATMENT ADMINISTRATION WAS PERFORMED ON (B)(6) 2024 TO MULTIPLE SELECTIVE THROUGH THE FEMORAL ARTERY USING TWO DOSE VIALS. TOTAL ADMINISTERED ACTIVITY WAS 1.65 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. DOSE TO PERFUSED LIVER WAS 1433 GY AND DOSE TO TOTAL NORMAL TISSUE WAS 62.9 GY. LUNG DOSE CALCULATION WAS 2.4. ON (B)(6) 2024, 67 DAYS POST THE THERASPHERE ADMINISTRATION SUBJECT WAS NOTED WITH ASCITES. ON (B)(6) 2024, CHILD-PUGH SCORE WAS ASSESSED AS B (FUNCTIONAL COMPROMISE, WORSENING DISEASE) 7-9 POINTS. ON (B)(6) 2024, THE SUBJECT UNDERWENT PARACENTESIS TO RELIEVE ASCITES CAUSED BY DETERIORATING LIVER FUNCTION. ANOTHER PARACENTESIS WAS PERFORMED REVEALING AN INFECTION, AND ANTIBIOTICS WERE ADMINISTERED ACCORDINGLY. ASCITES WAS MEDICALLY MANAGED

  Patient problems: Ascites; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 21552490 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) TRIAL. IT WAS REPORTED THAT NAUSEA OCCURRED REQUIRING PRESCRIPTION MEDICATION. ON (B)(6)2024, THE SUBJECT RECEIVED A THIRD ADMINISTRATION OF STUDY TREATMENT, THERASPHERE. PRE-TREATMENT (MACRO AGGREGATED ALBUMIN) MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS (B)(4). THERASPHERE ADMINISTERED TO THE LIVER WAS MULTIPLE SELECTIVE, SIMILAR (=1CM) THROUGH FEMORAL ARTERY, AND (B)(4) DOSE VIALS WERE ADMINISTERED. ON (B)(6)2024, SAME DAY POST THIRD THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH NAUSEA. SUBJECT RECEIVED TREATMENT WITH ZOFRAN (4MG/AS NEEDED) AS CORRECTIVE TREATMENT FOR THE EVENT.

  Patient problems: Nausea

  MAUDE report 20518164 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ROWAN CLINICAL TRIAL. IT WAS REPORTED THAT NAUSEA OCCURRED REQUIRING PRESCRIPTION MEDICATION. ON (B)(6) 2024, THE SUBJECT RECEIVED A THIRD ADMINISTRATION OF STUDY TREATMENT, THERASPHERE. PRE-TREATMENT (MACRO AGGREGATED ALBUMIN) MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 7.7%. THERASPHERE ADMINISTERED TO THE LIVER WAS MULTIPLE SELECTIVE, SIMILAR (<=1CM) THROUGH FEMORAL ARTERY, AND 3 DOSE VIALS WERE ADMINISTERED. ON (B)(6) 2024, SAME DAY POST THIRD THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH NAUSEA. SUBJECT RECEIVED TREATMENT WITH ZOFRAN (4MG/AS NEEDED) AS CORRECTIVE TREATMENT FOR THE EVENT.

  Patient problems: Nausea

  MAUDE report 20518078 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) TRIAL. IT WAS REPORTED THAT NAUSEA OCCURRED REQUIRING PRESCRIPTION MEDICATION. ON (B)(6)2024, THE SUBJECT RECEIVED A THIRD ADMINISTRATION OF STUDY TREATMENT, THERASPHERE. PRE-TREATMENT (MACRO AGGREGATED ALBUMIN) MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS (B)(4). THERASPHERE ADMINISTERED TO THE LIVER WAS MULTIPLE SELECTIVE, SIMILAR (=1CM) THROUGH FEMORAL ARTERY, AND 3 DOSE VIALS WERE ADMINISTERED. ON (B)(6) 2024, SAME DAY POST THIRD THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH NAUSEA. SUBJECT RECEIVED TREATMENT WITH ZOFRAN (4MG/AS NEEDED) AS CORRECTIVE TREATMENT FOR THE EVENT.

  Patient problems: Nausea

  MAUDE report 20518033 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED MILD ABDOMINAL PAIN TREATED WITH MEDICATION. THE SUBJECT WAS ENROLLED INTO (B)(6) STUDY 25-OCT-2023. PRE-TREATMENT MAA IMAGING PRIOR TO 1ST THERASPHERE TREATMENT, DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. THE DOSE TO PERFUSED LIVER WAS 61.6 GY AND THE DOSE TO TOTAL NORMAL TISSUE WAS 529.3 GY. THE LUNG SHUNT CALCULATION WAS 8%. ON THE SAME DAY, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER SELECTIVE (<=2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY. 1 DOSE VIAL WAS ADMINISTERED. TOTAL ADMINISTERED ACTIVITY WAS 2.57 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. ON (B)(6) 2023, 9 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT PRESENTED WITH ABDOMINAL PAIN. SEVERITY (CTCAE V5.0 GRADE): GRADE 1 (MILD). THE ADVERSE EVENT WAS CONSIDERED AS NON-SERIOUS. THE SUBJECT WAS STARTED ON OXYCODONE FOR THE PAIN AND ZOFRAN-ODT FOR NAUSEA. NO OTHER ACTIONS WERE TAKEN TO TREAT THE EVENT. ON 14-DEC-2023, THE EVENT WAS CONSIDERED AS RESOLVED. ON (B)(6) 2023, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300

  Patient problems: Abdominal Pain; Decreased Appetite; Fatigue; Low White Blood Cell Count

  MAUDE report 18659331 ↗