MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES

Model Number	990700.SPE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Encephalopathy (1833); Hemorrhage/Blood Loss/Bleeding (1888); Hyperbilirubinemia (1903); Ascites (2596)
Date of Event	08/01/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: THERASPHERE
• Common Device Name: YTTRIUM-90 GLASS MICROSPHERES
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 10659524
• Report Number: 3002124543-2020-00020
• Device Sequence Number: 3564416
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 990700.SPE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention
• Patient Age: 48 YR