Medical assessment concurred with the assessment that the ascites, hyperbilirubinemia, rectal bleeding and encephalopathy were all related to the therasphere procedure.Encephalopathy, hyperbilirubinemia, ascites, bleeding and death are potential adverse events that are listed in the ifu.
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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 procedure.
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