MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (4 GBQ); 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); Hyperbilirubinemia (1903); Liver Damage/Dysfunction (1954)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced radioembolization-induced liver disease that was treated with medication.The subject was enrolled into a clinical study on (b)(6) 2025.Pre-treatment maa imaging documented a significantly higher perfusion of maa on tumors, dose to perfused liver 143 gy and dose to total normal tissue was currently unavailable.Lung shunt calculation was 0 percent.On (b)(6) 2025, the treatment with therasphere was performed to the liver was lobar (2 segments in the perfused volume) through femoral artery and 1 dose vial was administered; total administered activity dose was reported as 1.613 gbq.Post treatment dosimetry documented between avid uptake in target lesion and avid uptake in all lesion?s distribution of y90 on tumors.The dose to perfused liver normal tissue was 361 gy and dose to liver normal tissue was 26 gy.Lung dose calculation was 0.On (b)(6) 2025, combination therapy with 1500 mg durvalumab followed by 300 mg of tremelimumab were administered intravenously.On (b)(6) 2025, 39 days post the therasphere administration subject noted with radioembolization-induced liver disease (reild) and was treated medically with prednisolone (60 mg /oral daily).
Additional Manufacturer Narrative
D3, manufacturer zip/postal: gu9 8ql.G1, mfr site zip/post code: gu9 8ql.The lot number was not provided from the clinical study, thus unable to provide the complete unique identifier (udi) # and other product specific information.
Event or Problem Description
It was reported that the patient experienced radioembolization-induced liver disease that was treated with medication.The subject was enrolled into a clinical study on (b)(6) 2025.Pre-treatment maa imaging documented a significantly higher perfusion of maa on tumors, dose to perfused liver 143 gy and dose to total normal tissue was currently unavailable.Lung shunt calculation was 0 percent.On (b)(6) 2025, the treatment with therasphere was performed to the liver was lobar (2 segments in the perfused volume) through femoral artery and 1 dose vial was administered; total administered activity dose was reported as 1.613 gbq.Post treatment dosimetry documented between avid uptake in target lesion and avid uptake in all lesion distribution of y90 on tumors.The dose to perfused liver normal tissue was 361 gy and dose to liver normal tissue was 26 gy.Lung dose calculation was 0.On (b)(6) 2025, combination therapy with 1500 mg durvalumab followed by 300 mg of tremelimumab were administered intravenously.On (b)(6) 2025, 39 days post the therasphere administration subject noted with radioembolization-induced liver disease (reild) and was treated medically with prednisolone (60 mg /oral daily).Additional information was reported two new additional adverse events; anemia on (b)(6) 2025 and an increase in albumin on (b)(6) 2025.No actions taken were taken to treat either new event; however, it was noted that the subject was still taking prednisolone (20 mg/oral daily) for the event of reild.
Additional Manufacturer Narrative
D3, manufacturer zip/postal: (b)(6).G1, mfr site zip/post code: (b)(6).The lot number was not provided from the clinical study, thus unable to provide the complete unique identifier (udi) # and other product specific information.
Event or Problem Description
It was reported that the patient experienced radioembolization-induced liver disease that was treated with medication.The subject was enrolled into a clinical study on (b)(6) 2025.Pre-treatment maa imaging documented a significantly higher perfusion of maa on tumors, dose to perfused liver 143 gy and dose to total normal tissue was currently unavailable.Lung shunt calculation was 0 percent.On (b)(6) 2025, the treatment with therasphere was performed to the liver was lobar (2 segments in the perfused volume) through femoral artery and 1 dose vial was administered; total administered activity dose was reported as 1.613 gbq.Post treatment dosimetry documented between avid uptake in target lesion and avid uptake in all lesion distribution of y90 on tumors.The dose to perfused liver normal tissue was 361 gy and dose to liver normal tissue was 26 gy.Lung dose calculation was 0.On (b)(6) 2025, combination therapy with 1500 mg durvalumab followed by 300 mg of tremelimumab were administered intravenously.On (b)(6) 2025, 39 days post the therasphere administration subject noted with radioembolization-induced liver disease (reild) and was treated medically with prednisolone (60 mg /oral daily).Additional information was reported two new additional adverse events; anemia on (b)(6) 2025 and an increase in albumin on (b)(6) 2025.No actions taken were taken to treat either new event; however, it was noted that the subject was still taking prednisolone (20 mg/oral daily) for the event of reild.Additional information was again reported that clarified that the event on 10-mar-25 was a decrease in albumin (not increase).It also reported on (b)(6) 2025 there was an increase in bilirubin.No actions were taken.
Additional Manufacturer Narrative
D3, manufacturer zip/postal: (b)(6), g1, mfr site zip/post code: (b)(6).The lot number was not provided from the clinical study, thus unable to provide the complete unique identifier (udi) # and other product specific information.

• Brand Name: THERASPHERE Y-90 (4 GBQ)
• 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: 21713288
• Report Number: 2124215-2025-19057
• Device Sequence Number: 21320218
• Product Code: NAW
• UDI-Device Identifier: 05060116920352
• UDI-Public: (01)05060116920352
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2025

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: 02/28/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 06/04/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/02/2025; 07/01/2025
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 77 KG