TheraSphere Y90 Glass Microspheres 6.5 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060116920390), received between Dec 28, 2018 and Mar 29, 2024 — classified as 2 deaths, 1 injury.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROACTIF CLINICAL STUDY IT WAS REPORTED THAT THE SUBJECT EXPERIENCED EDEMATO-ASCITIC DECOMPENSATION 114 DAYS POST INDEX PROCEDURE. THE SUBJECT WAS HOSPITALIZED, AND INTERVENTION WAS PERFORMED AS A RESULT. PRIOR TO THE INDEX PROCEDURE, ADVANCED MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT DOSIMETRY DOCUMENTED, DOSE TO TOTAL PERFUSED LIVER WAS 614 GY AND DOSE TO TOTAL PERFUSED TUMOR WAS 800 GY. ON (B)(6) 2023, THE SUBJECT WAS ENROLLED INTO THE PROACTIF CLINICAL STUDY AND THE TREATMENT WITH THERASPHERE Y-90 GLASS MICROSPHERES WAS PERFORMED ON THE SAME DAY. THE TYPE OF THERASPHERE INFUSION WAS SELECTIVE. 3.143 GBQ OF THERASPHERE WAS ADMINISTERED TO THE LEFT MEDIAN SECTOR (SEGMENT IV). POST TREATMENT DOSIMETRY DOCUMENTED THE UPTAKE OF THE DELIVERED DOSE TO PERFUSED LIVER WAS 603 GY. UPTAKE OF THE DELIVERED DOSE TO PERFUSED TUMOR WAS 758 GY. ON 22-NOV-2023, THE SUBJECT PRESENTED FOR A FOLLOW-UP VISIT. DURING THIS TIME, ECOG SCORE WAS 1. ON 15-DEC-2023, 114 DAYS POST INDEX PROCEDURE, THE SUBJECT'S HEALTH CONDITION DETERIORATED. ON THE SAME DAY, THE SUBJECT WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION. DURING THIS TIME, THE SUBJECT WAS NOTED WIT

  Patient problems: Ascites

  MAUDE report 19005376 ↗
• DeathMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS FOLLOW-UP TO USADE REPORTS ORIGINALLY SUBMITTED IN 2014 (MANUFACTURE REPORT NUMBER: 3002124545-2014-00012). 2 THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THIS FATAL EVENT. REFER TO MDR 3002124543-2019-00032 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. (B)(4). SUBJECT: (B)(6). LAST SAE REPORT: 15 APR 2019. SAE: RILD (RADIO-EMBOLIZATION INDUCED LIVER DISEASE) (RADIATION HEPATITIS). THIS REPORT CONCERNS SUBJECT (B)(6), A FEMALE SUBJECT WHO WAS BORN IN (B)(6) ENROLLED IN STUDY (B)(6) ENTITLED "(B)(6)". ON (B)(6) 2014, THE SUBJECT RECEIVED FIRST CYCLE OF SECOND-LINE CHEMOTHERAPY, FOLFIRI REGIMEN (IRINOTECAN, FOLINIC ACID AND FLUOROURACIL). ON (B)(6) 2014, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 2 VIALS OF THERASPHERE®. THE RIGHT HEPATIC LOBE WAS TREATED AT A DOSE OF 118 GY (LOT NO 4990036/18, EXPIRY DATE: 07 MAR 2014) AND AT A DOSE OF 136 GY IN THE LEFT HEPATIC LOBE (LOT NO 4990031, EXPIRY DATE: 07 MAR 2014). ON (B)(6) 2014, THE SUBJECT RECEIVED MOST RECENT CYCLE (FIFTH) PRIOR TO THE EVENT OF SECOND-LINE CHEMOTHERAPY, FOLFIRI REGIMEN (IRINOTECAN 295.2 MG INTRAVENOUS (IV), FOLINIC ACID 35 MG IV AND FLUOROURACI

  Patient problems: Death; Hepatitis; Liver Damage/Dysfunction

  MAUDE report 8572964 ↗
• DeathDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A FOLLOW-UP REPORT TO UPDATE SUBJECT WEIGHT, CAUSE OF DEATH, STUDY DEVICE HEPATIC SEGMENTS TREATED, STUDY TREATMENT INFORMATION, PRINCIPAL INVESTIGATOR'S STATEMENT REGARDING CAUSALITY AND THE COMPANY ASSESSMENT. 2 THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THE DEATH OF THE PATIENT. REFER TO MFR# 3002124543-2018-00054 FOR ANOTHER DEVICE ASSOCIATED WITH THIS EVENT. MFR # 3002124543-2018-00053. INTERNAL MCN: (B)(4). SUBJECT NUMBER: (B)(6). LAST SAE REPORT: 08 JAN 2019. SAE: DEATH. ON (B)(6) 2017, SEGMENT IV OF THE RIGHT HEPATIC LOBE WAS TREATED WITH THE STUDY DEVICE THERASPHERE®. ON (B)(6) 2017, SEGMENTS II AND III WERE TREATED WITH THE STUDY DEVICE THERASPHERE®. THE INVESTIGATOR CONFIRMED THAT THE CAUSE OF DEATH WAS UNKNOWN. TREATMENT WITH STUDY DRUG SORAFENIB WAS STARTED ON (B)(6) 2017 WITH A DOSE OF 200 MG, BID, AND ON (B)(6) 2018 SORAFENIB WAS DISCONTINUED DUE TO UNKNOWN REASONS. THE INVESTIGATOR STATED THAT WHILE IT WAS EXTREMELY UNLIKELY THAT THERE WAS A RELATIONSHIP BETWEEN THE SUBJECT'S DEATH AND THE STUDY DEVICE, PROCEDURE OR SORAFENIB TREATMENT, WITHOUT ACCOMPANYING INFORMATION FROM THE SUBJECT'S CARE PROVI

  Patient problems: Death; No Code Available

  MAUDE report 8202102 ↗