MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW

Model Number	990700.SPE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Liver Damage/Dysfunction (1954); Pleural Effusion (2010); Jaundice (2187); Radiation Sickness Syndrome (2256); Ascites (2596)
Date of Event	05/27/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Btg medical assessment: the investigator, named the event as reild, radio embolisation induced liver disease, that is a life-threatening liver damage characterised by jaundice and ascites developing 4-8 weeks after treatment, with pathologic changes consistent with vod in the most severe cases.In the edc (electronic data capture) did not document the biology and clinical data (ascites, encephalopathy, child score, bclc).Adverse event assessment: reild (radiation induced liver disease) severity: grade 4; serious event - lead to death; anticipated events; related to device.No device malfunction was reported and no corrective and preventive action (capa) plan has been unidentified.The lot number associated with the therasphere administration was not reported, therefore no investigation could be performed.If additional information becomes available, a follow up report will be submitted.No other information is available that could confirm/deny the alleged event.At this time this report is considered final.
Event or Problem Description
Auto-notification received from datatrak 12-mar-2020 for a patient enrolled on the (b)(6)study pt: (b)(6) is a (b)(6) old male patient.Weight: (b)(6) kg.Main comorbidities: arterial hypertension; alcohol intake history; tobacco intake history.Diagnosed with hcc (b)(6) 2016.2-4 lesions - right and left segments.Location of index lesion = vi.Pvt present - yes (tumoural) no extra hepatic disease.Prior anti-cancer therapy: loco regional liver treatment(s) = 2.Ablation: rfa, microwave or cryo.Event: on (b)(6) 2019, patient was administered 3.225 gbq of therasphere in the right liver.On (b)(6) 2019, patient was admitted to the hospital with hepatitis decompensation with ascites and jaundice at 1-month post-radio-embolisation.Further, ascites and pleural effusion apparition with repeated paracentesis has been reported.On (b)(6) 2019, radio-induced liver disease was reported.Seriousness criteria - led to a death on (b)(6) 2019.The investigator has listed the causality probably related to the administration procedure and to the device.Sae assessed by investigator: related to administration procedure: probably.Related to therasphere device: probably.This event is part of a clinical trial registry and was not reported to btg in 2019 the reported events are known adverse events listed in the ifu/risk management documentation.

• Brand Name: THERASPHERE
• Common Device Name: YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 9932767
• Report Number: 3002124543-2020-00007
• Device Sequence Number: 3882073
• Product Code: NAW
• UDI-Device Identifier: 05060116920345
• UDI-Public: 05060116920345
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

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
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/07/2020
• 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: 66 YR
• Patient Weight: 80