TheraSphere Y90 Glass Microspheres 11.5 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060116920475), received between Jun 23, 2017 and Jun 23, 2017 — classified as 1 death.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJun 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). SUBJECT (B)(6). LAST SAE REPORT: (B)(6) 2017. SAE: HEPATIC DECOMPENSATION (HEPATIC FAILURE). THIS REPORT CONCERNS SUBJECT (B)(6), A (B)(6) MALE WHO WAS ENROLLED IN STUDY (B)(6) ENTITLED "A PHASE III CLINICAL TRIAL OF INTRA-ARTERIAL THERASPHERE® IN THE TREATMENT OF PATIENTS WITH UNRESPECTABLE HEPATOCELLULAR CARCINOMA (HCC). ON (B)(6) 2016, THE SUBJECT RECEIVED TREATMENT WITH STUDY DEVICE THERASPHERE® TOTAL 117 GY FOR HEPATOCELLULAR CARCINOMA IN THE RIGHT LOBE. ON (B)(6) 2016, THE SUBJECT RECEIVED TREATMENT WITH STUDY DEVICE THERASPHERE® TOTAL 114 GY FOR HEPATOCELLULAR CARCINOMA IN THE LEFT LOBE. ON (B)(6) 2016, THE SUBJECT COMMENCED TREATMENT WITH STANDARD OF CARE THERAPY (SORAFENIB), THE DOSAGE OF WHICH WAS NOT REPORTED AT THE TIME OF REPORTING THIS EVENT. ON (B)(6) 2016, STANDARD OF CARE THERAPY (SORAFENIB) HAS BEEN DISCONTINUED DUE TO LIVER FUNCTION DETERIORATION AND RADIATION HEPATITIS. RELEVANT MEDICAL HISTORY INCLUDED GOUT, DEPRESSION, OESOPHAGEAL VARICES, THROMBOCYTOPENIA, PORTAL HYPERTENSION, FIBROMYALGIA, SERO NEGATIVE ARTHRITIS AND FIRST DEGREE ARTERIO-VENTRICULAR BLOCK. CONCOMITANT MEDICATIONS INCLUDED LANSOPRAZOLE, NAPROXEN, TRAMADOL, FLUOXETINE, AND ALLOPURINOL.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 6663506 ↗