MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (14 GBQ) CE MARK; MICROSPHERES RADIONUCLIDE

Model Number	2361-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Liver Damage/Dysfunction (1954); Low White Blood Cell Count (4433); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 subject experienced anemia requiring medication as a result of the therasphere device or procedure.The subject was enrolled into the study on (b)(6) 2024.Pre-treatment macroaggregated albumin (maa) imaging documented a significantly higher perfusion of maa on tumors.Dose to perfused liver was 258 gy, and lung shunt calculation was 0%.On (b)(6) 2025, the treatment with therasphere was performed.Therasphere was administered to the liver through the femoral artery via two dose vials.Total administered activity dose was 8.245 gbq.Post-treatment dosimetry documented avid uptake in all lesions of y-90 on tumors.Dose to perfused liver was 258 gy and dose to total normal tissue was 82 gy.Lung dose calculation was 0.On (b)(6) 2025, five days following therasphere administration, the subject was noted with anemia, lymphopenia, and aspartate aminotransferase (asat) increase.The anemia was medically treated with speciafoldine (5 mg/oral/daily).No action was taken to treat the lymphopenia and increased asat levels.On (b)(6) 2025, the lymphopenia and increased asat levels were resolved.On (b)(6) 2025, the anemia was resolved.
Event or Problem Description
It was reported that the subject experienced anemia requiring medication as a result of the thermosphere device or procedure.The subject was enrolled into the study on (b)(6) 2024.Pre-treatment macroaggregated albumin (maa) imaging documented a significantly higher perfusion of maa on tumors.Dose to perfused liver was 258 gy, and lung shunt calculation was 0%.On (b)(6) 2025, the treatment with thermosphere was performed.Thermosphere was administered to the liver through the femoral artery via two dose vials.Total administered activity dose was 8.245 gbq.Post-treatment dosimetry documented avid uptake in all lesions of y-90 on tumors.Dose to perfused liver was 258 gy and dose to total normal tissue was 82 gy.Lung dose calculation was 0.On (b)(6) 2025, five days following therasphere administration, the subject was noted with anemia, lymphopenia, and aspartate aminotransferase (asat) increase.The anemia was medically treated with speciafoldine (5 mg/oral/daily).No action was taken to treat the lymphopenia and increased asat levels.On (b)(6) 2025, the lymphopenia and increased asat levels were resolved.On (b)(6) 2025, the anemia was resolved.
Additional Manufacturer Narrative
Updated fields: b5 - describe event or problem.H6 - patient codes, impact codes, evaluation conclusion codes.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.
Additional Manufacturer Narrative
Updated fields: b5: describe event or problem.H6: patient codes, impact codes, evaluation conclusion codes.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 subject experienced anemia requiring medication as a result of the therasphere device or procedure.The subject was enrolled into the study on (b)(6) 2024.Pre-treatment macroaggregated albumin (maa) imaging documented a significantly higher perfusion of maa on tumors.Dose to perfused liver was 258 gy, and lung shunt calculation was 0%.On (b)(6) 2025, the treatment with therasphere was performed.Therasphere was administered to the liver through the femoral artery via two dose vials.Total administered activity dose was 8.245 gbq.Post-treatment dosimetry documented avid uptake in all lesions of y-90 on tumors.Dose to perfused liver was 258 gy and dose to total normal tissue was 82 gy.Lung dose calculation was 0.On (b)(6) 2025, five days following therasphere administration, the subject was noted with anemia, lymphopenia, and aspartate aminotransferase (asat) increase.The anemia was medically treated with speciafoldine (5 mg/oral/daily).No action was taken to treat the lymphopenia and increased asat levels.On (b)(6) 2025, the lymphopenia and increased asat levels were resolved.On (b)(6) 2025, the anemia was resolved.It was further reported that the adverse events of anemia, lymphopenia, asat increase, and amylase increase were not alleged to have been related to the therasphere device or procedure.

• Brand Name: THERASPHERE Y-90 (14 GBQ) CE MARK
• Common Device Name: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house, farnham bus prk; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house, farnham bus prk; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22387089
• Report Number: 2124215-2025-43635
• Device Sequence Number: 18333104
• Product Code: NAW
• UDI-Device Identifier: 05060116920529
• UDI-Public: (01)05060116920529
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2025

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: 2361-02
• Device Catalogue Number: 2361-02
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 07/31/2025; 09/16/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/27/2025; 10/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: THERASPHERE Y-90 (7.5 GBQ) CE MARK.; THERASPHERE Y-90 (7.5 GBQ) CE MARK.; THERASPHERE Y-90 (7.5 GBQ) CE MARK.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown