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

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

Patient Problem Alteration in Body Temperature (4568)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

This report will be updated should additional information become available.

Event Description

It was reported that a fever occurred.On (b)(6) 2021, the patient was enrolled into the (b)(6) study and the treatment with therasphere was performed on same day.1.67 gbq was administered through vial-1 and 1.51 gbq was administered through vial-2.Total dose of 3.18 gbq was administered to the patient.Post-treatment macroaggregated albumin (maa) imaging documented a strong uptake of maa on tumors, doses to perfused liver was 100 gy and dose to perfused tumor was 151 gy.On (b)(6) 2021, 50 days post therasphere administration, the patient developed fever (39.5 celsius) and was hospitalized for further evaluation and treatment on (b)(6) 2021.The patient was treated with concomitant medication and the event was considered resolved on (b)(6) 2021.Patient was discharged on the same day.This event is listed as causally related to therasphere.No further patient events were reported.No other information is known at this time.This report will be updated should additional information become available.

• 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: 11726661
• MDR Text Key: 262909637
• Report Number: 3002124543-2021-00012
• Device Sequence Number: 1
• Product Code: NAW
• 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
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• 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): Required Intervention