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

Model Number 3GBQ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ascites (2596)

Event Date 05/11/2016

Event Type  Injury  

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 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
• Type of Device: 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
• Manufacturer (Section G): BIOCOMPATIBLES UK; chapman house; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: sandra bausback-aballo ; 300 four falls corporate cente; 300 conshohocken state road; west conshohocken,, PA 19428-2998 ; 6103311537
• MDR Report Key: 8784528
• MDR Text Key: 150848415
• Report Number: 3002124543-2019-00052
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 3GBQ
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR