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

Model Number	990700.SPE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Cognitive Changes (2551)
Date of Event	07/26/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3002124543-2020-00018
• Device Sequence Number: 17035147
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/18/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR