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

Model Number 990700.SPE

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

Patient Problems Abdominal Pain (1685); Cognitive Changes (2551)

Event Date 07/26/2020

Event Type  Injury  

Event Description

Patient (b)(6) with a hcc tumour in segment viii of the right liver was enrolled in the (b)(6) registry study on (b)(6) 2020.The patient received therasphere administration on the same day to the right liver.The perfused liver volume and absorbed dose has not been reported.On (b)(6) 2020 (45 days post therasphere administration), the patient presented with fever (38.2 c), abdominal pain and cognitive disturbance.The patient was hospitalized for further evaluation and treatment, and was treated with antibiotics and surgical intervention.The patient also presented in (b)(6) 2020 with anorexia (grade 3), which was also assessed to be related to therasphere procedure, but no action was taken to resolve the anorexia.The physician assessed the abdominal pain and cognitive disturbance as a grade 2 serious adverse event (as defined in the ctcae v5.0 adverse event reporting guideline, and as probably related to the therasphere administration procedure.

Manufacturer Narrative

Medical assessment documented that the abdominal pain, fever, confusion were serious adverse events that led to hospital admission, whereas the reported anorexia did not result in hospitalisation.The medical assessment believes that all four reported adverse events are grade 3 (as described in the ctcae v5.0).The medical assessment concurs that all reported adverse events are related to the therasphere device.Anoreia, abdominal pain, fever and confusion are all listed as potential adverse events in the product labelling, and are therefore known risks associated with the use of therasphere.

Event Description

Patient (b)(6) with a hcc tumour in segment viii of the right liver was enrolled in the proactif registry study on (b)(6) 2020.The patient received therasphere administration on the same day to the right liver.The perfused liver volume and absorbed dose has not been reported.On (b)(6) 2020 (45 days post therasphere administration), the patient presented with fever (38.2 c), abdominal pain and cognitive disturbance.The patient was hospitalized for further evaluation and treatment, and was treated with antibiotics and surgical intervention.The patient also presented in (b)(6) 2020 with anorexia (grade 3), which was also assessed to be related to therasphere procedure, but no action was taken to resolve the anorexia.The physician assessed the abdominal pain and cognitive disturbance as a grade 2 serious adverse event (as defined in the ctcae v5.0 adverse event reporting guideline, and as probably related to the therasphere administration procedure.

• Brand Name: THERASPHERE
• Type of Device: 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: 10659499
• MDR Text Key: 216395785
• Report Number: 3002124543-2020-00018
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• Combination Product (y/n): N
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 990700.SPE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR