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	Abdominal Pain (1685); Fatigue (1849); Fever (1858); Nausea (1970); Pain (1994); Constipation (3274); Low White Blood Cell Count (4433)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D3: manufacturer zip/postal code: gu9 8ql.G1: mfr site zip/post code: gu9 8ql.Based on the nature of the product, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient had nausea and pain, requiring prescription medication.The subject was enrolled into a clinical study on (b)(6) 2025.Pre-treatment macroaggregated albumin (maa) imaging documented a significantly higher perfusion of maa on tumors.Lung shunt calculation was 8.7 %.On (b)(6) 2025, the treatment with therasphere was performed.Therasphere was administered to the liver was selective (<=2 segments in the perfused volume) through femoral artery and 5 dose vials were administered; total administered activity dose was 5.21 gbq.Post treatment dosimetry documented avid uptake in target lesion distribution of y90 on tumors.Lung dose calculation was 22.7.On (b)(6) 2025, combination therapy with 1500 mg durvalumab followed by 300 mg of tremelimumab were administered intravenously.On (b)(6) 2025, monotherapy with 1500 mg durvalumab was administered intravenously.On (b)(6) 2025, 1 day post the therasphere administration, the subject was noted with nausea, shoulder pain, right upper quadrant abdominal pain, constipation, low grade fever, and fatigue.The nausea was medically treated with ondansetron odt (zofran-odt) and olanzapine (zyprexa).Shoulder and abdominal pain were treated with oxycodone.Constipation was medically treated with senna and miralax.No actions were taken to treat the events low grade fever and fatigue.On (b)(6) 2025, 13 days post the therasphere administration and on the same day of combination therapy, subject was noted with decreased absolute lymphocyte count (alc).No action was taken to treat the event; however, the subject was kept under monitoring.
Event or Problem Description
It was reported that the patient had nausea and pain, requiring prescription medication.The subject was enrolled into a clinical study on (b)(6) 2025.Pre-treatment macroaggregated albumin (maa) imaging documented a significantly higher perfusion of maa on tumors.Lung shunt calculation was 8.7 %.On (b)(6) 2025, the treatment with therasphere was performed.Therasphere was administered to the liver was selective (<=2 segments in the perfused volume) through femoral artery and 5 dose vials were administered; total administered activity dose was 5.21 gbq.Post treatment dosimetry documented avid uptake in target lesion distribution of y90 on tumors.Lung dose calculation was 22.7.On (b)(6) 2025, combination therapy with 1500 mg durvalumab followed by 300 mg of tremelimumab were administered intravenously.On (b)(6) 2025, monotherapy with 1500 mg durvalumab was administered intravenously.On (b)(6) 2025, 1 day post the therasphere administration, the subject was noted with nausea, shoulder pain, right upper quadrant abdominal pain, constipation, low grade fever, and fatigue.The nausea was medically treated with ondansetron odt (zofran-odt) and olanzapine (zyprexa).Shoulder and abdominal pain were treated with oxycodone.Constipation was medically treated with senna and miralax.No actions were taken to treat the events low grade fever and fatigue.On (b)(6) 2025, 13 days post the therasphere administration and on the same day of combination therapy, subject was noted with decreased absolute lymphocyte count (alc).No action was taken to treat the event; however, the subject was kept under monitoring.
Additional Manufacturer Narrative
D3: manufacturer zip/postal code: (b)(6).G1: mfr site zip/post code: (b)(6).Based on the nature of the product, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.

• 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: 22800246
• Report Number: 2124215-2025-55991
• Device Sequence Number: 8789438
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 07/21/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/05/2025
• 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: 77 YR
• Patient Sex: Male