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

Model Number	3GBQ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ascites (2596)
Date of Event	05/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The events were reported through a retrospective clinical trial.The events are considered serious due to hospitalization and related to therasphere administration.Btg medical assessment: occurrence of ascites around 2 months after therasphere administration for a multifocal hcc of the right liver.On the (b)(6) 2016 imaging, before therasphere administration, the patient had small amount of ascites that did not require treatment on the (b)(6) 2016 ct ascites important was discovered, without any other sign of liver failure (no encephalopathy, no decrease of albumin, no increase in bilirubin), no disease progression documented.It is not known if patient has other factor for hepatic decompensation (alcohol or else).He had paracentesis on (b)(6) 2016 and (b)(6) 2016, as well as a thoracentesis on (b)(6) 2017.The patient was transplanted on (b)(6) 2017.Adverse event: ascites; severity grade 3; serious adverse event; related to device; anticipated.Ascites is an anticipated adverse event listed in the ifu/risk management documentation.The events were not reported to btg in 2016.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 datatrak 28-jun-2019.Subject (b)(6) enrolled on the (b)(6) study is a (b)(6) male patient diagnosed with hcc on (b)(6) 2015; unilobar disease (right liver lobe).Portal hypertension - not present.Etiologic associations: liver cirrhosis, (b)(6), no prior sorafenib treatment before therasphere treatment, baseline bclc stage: b, no previous hcc surgery, baseline albumin not documented, bilirubine 2.5 mg/dl.Therasphere treatment: (b)(6) 2016.Activity recorded as start of infusion: 2.923 gbq.Residuals remains in delivery set: 0.01 gbq.Lung shunt fraction 5.1%.On (b)(6) 2016 patient presented with ascites (grade 3).It was reported the patient is receive paracentesis to remove fluid.Patient was hospitalized (unknown admission/discharge dates).Outcome: recovering/resolving.Additional information received 08-jul-2019: reporter confirmed: patient did develop ascites after the y90.He had a small amount not warranting treatment seen on the (b)(6) 2016 ct.He had a lot of ascites on the (b)(6) 2016 ct, and had a 5600 ml paracentesis on (b)(6) 2016 (that appears to have been his first para).His total bilirubin on (b)(6) was, surprisingly, down to 1.7 on that date.It was 2.3 on (b)(6) 2016, i.E., before treatment.He had paras on (b)(6) 2016 and (b)(6) 2016, as well as a thoracentesis on (b)(6) 2017.He had his transplant on (b)(6) 2017.The reporting physician stated that "although he had hcv cirrhosis, and people with cirrhosis get ascites- i'd call it probably related because it happened 5 months after y90, which is a reasonable time course.Ascites is an anticipated adverse event listed in the ifu/risk management documentation.The events were not reported to btg in 2016.

• 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: 8784528
• Report Number: 3002124543-2019-00052
• Device Sequence Number: 13962672
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2019

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: 3GBQ
• 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: 06/28/2019
• Initial Report FDA Received Date: 07/12/2019
• 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; Required Intervention
• Patient Age: 65 YR