MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (3 GBQ) US; MICROSPHERES RADIONUCLIDE

Model Number	2361-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Ascites (2596); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subject experienced ascites post-administration that was treated medically.The subject was enrolled into a clinical study on (b)(6) 2024.Pre-treatment maa imaging documented a significantly higher perfusion of maa on tumors, dose to perfused liver was 1465.4 gy; dose to total normal tissue was 62.9 gy.Lung shunt calculation was 3 percent.Therasphere treatment administration was performed on (b)(6) 2024 to multiple selective through the femoral artery using two dose vials.Total administered activity was 1.65 gbq.Post treatment dosimetry documented avid uptake in target lesion distribution of y90 on tumors.Dose to perfused liver was 1433 gy and dose to total normal tissue was 62.9 gy.Lung dose calculation was 2.4.On (b)(6) 2024, 67 days post the therasphere administration subject was noted with ascites.On (b)(6) 2024, child-pugh score was assessed as b (functional compromise, worsening disease) 7-9 points.On (b)(6) 2024, the subject underwent paracentesis to relieve ascites caused by deteriorating liver function.Another paracentesis was performed revealing an infection, and antibiotics were administered accordingly.Ascites was medically managed with spironolactone 50 mg/ daily.No action was taken with regards to the study medication tremelimumab for the event, while durvalumab was interrupted on (b)(6) 2024 in response to the ascites.On (b)(6) 2024, ascites was treated medically with lasix 20 mg/ daily orally.On (b)(6) 2025, ascites was treated with paracentesis and amiloride 5 mg/daily orally.On (b)(6) 2025, ct scan findings showed lr-tr nonviable with no progression of disease.
Additional Manufacturer Narrative
D3, manufacturer zip/postal: (b)(4).G1, mfr site zip/post code: (b)(4).The vial lot number was not provided by the study.
Event or Problem Description
It was reported that this subject experienced ascites post-administration that was treated medically.The subject was enrolled into a clinical study on (b)(6) 2024.Pre-treatment maa imaging documented a significantly higher perfusion of maa on tumors, dose to perfused liver was 1465.4 gy; dose to total normal tissue was 62.9 gy.Lung shunt calculation was 3 percent.Therasphere treatment administration was performed on (b)(6) 2024 to multiple selective through the femoral artery using two dose vials.Total administered activity was 1.65 gbq.Post treatment dosimetry documented avid uptake in target lesion distribution of y90 on tumors.Dose to perfused liver was 1433 gy and dose to total normal tissue was 62.9 gy.Lung dose calculation was 2.4.On (b)(6) 2024, 67 days post the therasphere administration subject was noted with ascites.On (b)(6) 2024, child-pugh score was assessed as b (functional compromise, worsening disease) 7-9 points.On (b)(6) 2024, the subject underwent paracentesis to relieve ascites caused by deteriorating liver function.Another paracentesis was performed revealing an infection, and antibiotics were administered accordingly.Ascites was medically managed with spironolactone 50 mg/ daily.No action was taken with regards to the study medication tremelimumab for the event, while durvalumab was interrupted on (b)(6) 2024 in response to the ascites.On (b)(6) 2024, ascites was treated medically with lasix 20 mg/ daily orally.On (b)(6) 2025, ascites was treated with paracentesis and amiloride 5 mg/daily orally.On (b)(6) 2025, ct scan findings showed lr-tr nonviable with no progression of disease.It was further reported that the adverse event of ascites was not related to the therasphere device or procedure.
Additional Manufacturer Narrative
D3, manufacturer zip/postal: (b)(6).G1, mfr site zip/post code: (b)(6).The vial lot number was not provided by the study.

• Brand Name: THERASPHERE Y-90 (3 GBQ) US
• Common Device Name: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house, farnham bus prk; weydon lane, farnham; surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus prk; weydon lane, farnham; surrey ; UK
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21552490
• Report Number: 2124215-2025-11427
• Device Sequence Number: 15497713
• Product Code: NAW
• UDI-Device Identifier: 05060116921373
• UDI-Public: (01)05060116921373
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: 2361-03
• Device Catalogue Number: 2361-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Race: White