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

Model Number	5.2 GBQ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis (1971); Weakness (2145)
Date of Event	01/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Btg medical assessment: subject number: (b)(6).Adverse event: surinfection of hepatic necrosis.Start date: (b)(6) 2017.Relationship to study treatment: related.Serious adverse event? yes.Outcome: recovered/resolved.End date (b)(6) 2017.Pt (b)(6) is a (b)(6) year-old male diagnosed with hcc (b)(6) 2016.No presence of portal hypertension.Etiologic associations: liver cirrhosis.Alcohol.No prior sorafenib treatment before therasphere treatment.Baseline bclc stage: b.No ascites.Unilobar disease.Target lesion: liver, right lobe.Therasphere treatment: (b)(6) 2017.Activity recorded at start of infusion 5.2 gbq, no residuals remaining in delivery set.Lung shunt fraction 3%.Total perfused liver 71.2%.Events: asthenia - start unknown - (b)(6) 2017; toxicity grade 2 patient presented with surinfection of hepatic necrosis on (b)(6) 2017.Toxicity grade 4.Action taken: scan (b)(6) 2017 / endoscopy (b)(6) 2017 (gastritis diagnosed) / echography (b)(6) 2017 (normal) / cbeu un-j (b)(6) 2017 (negative).Asthena (weakness) and surinfection of hepatic necrosis (hepatic decompensation/infection) are anticipated adverse events listed in the study protocol/risk management documentation.The events were not reported to btg in 2017.Assessment: asthenia: severity 2; related to device; anticipated; non-serious surinfection of hepatic necrosis: severity 4; related to device; anticipated; serious.No device malfunction was reported and no corrective and preventive action (capa) plan has been identified.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 (b)(6) 02-oct-2019 for a patient enrolled on clinical trial (b)(6), target subject number: (b)(6).Subject number: (b)(6).Adverse event: surinfection of hepatic necrosis.Start date: (b)(6) 2017.Relationship to study treatment: related.Serious adverse event? yes.Outcome: recovered/resolved.End date: (b)(6) 2017.Pt (b)(6) is a (b)(6) year-old male diagnosed with hcc (b)(6) 2016.No presence of portal hypertension.Etiologic associations: liver cirrhosis.Alcohol no prior sorafenib treatment before therasphere treatment.Baseline bclc stage: b.No ascites.Unilobar disease.Target lesion: liver, right lobe.Therasphere treatment: (b)(6) 2017.Activity recorded at start of infusion 5.2 gbq, no residuals remaining in delivery set lung shunt fraction 3%.Total perfused liver 71.2%.Events: asthenia - start unknown - (b)(6) 2017; toxicity grade 2.Patient presented with surinfection of hepatic necrosis on (b)(6) 2017.Toxicity grade 4.Action taken: scan 23 (b)(6) 2017 / endoscopy (b)(6) 2017 (gastritis diagnosed) / echography (b)(6) 2017 (normal) / cbeu (b)(6) 2017 (negative).The events were not reported to btg in 2017.Asthena (weakness) and surinfection of hepatic necrosis (hepatic decompensation/infection) are anticipated adverse events listed in the risk management documentation/study protocol.No reported device malfunction.

• 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: 9151149
• Report Number: 3002124543-2019-00059
• Device Sequence Number: 16924892
• Product Code: NAW
• UDI-Device Identifier: 05060116920291
• UDI-Public: 05060116920291
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

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: 5.2 GBQ
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/03/2019
• 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: Hospitalization
• Patient Age: 56 YR