MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (11 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); Nausea (1970); Constipation (3274)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D3: manufacturer zip/postal code: gu9 8ql.G1: mfr site zip/post code: gu9 8ql.
Event or Problem Description
It was reported that the patient had abdominal pain requiring prescription medication.The subject was enrolled into the rowan clinical study on (b)(6) 2024.Pre-treatment macroaggregated albumin (maa) imaging documented a significantly higher perfusion of maa on tumors, dose to perfused liver, and dose to total.Lung shunt calculation was 7.02 %.On (b)(6) 2024, therasphere was administered.On (b)(6) 2024, combination therapy with 1500 mg durvalumab followed by 300 mg of tremelimumab were administered intravenously.On (b)(6) 2024, the subject was noted with fatigue and constipation.On (b)(6) 2024, the subject was noted with nausea.No actions were taken to treat the events of fatigue and nausea.The event of constipation was treated medically with 8.6 mg senna twice daily/oral from (b)(6) 2024.On (b)(6) 2024, the subject was noted with fatigue; no action was taken to treat the event.On (b)(6) 2024, the subject was noted with right upper quadrant abdominal pain, which was treated medically with 5 mg oxycodone as needed/oral from (b)(6) 2024.
Event or Problem Description
It was reported that the patient had abdominal pain requiring prescription medication.The subject was enrolled into a clinical study on (b)(6)2024.Pre-treatment macroaggregated albumin (maa) imaging documented a significantly higher perfusion of maa on tumors, dose to perfused liver, and dose to total.Lung shunt calculation was 7.02 %.On (b)(6)2024, therasphere was administered.On (b)(6)2024, combination therapy with 1500 mg durvalumab followed by 300 mg of tremelimumab were administered intravenously.On (b)(6)2024, the subject was noted with fatigue and constipation.On (b)(6)2024, the subject was noted with nausea.No actions were taken to treat the events of fatigue and nausea.The event of constipation was treated medically with 8.6 mg senna twice daily/oral from (b)(6)2024, the subject was noted with fatigue; no action was taken to treat the event.On (b)(6)2024, the subject was noted with right upper quadrant abdominal pain, which was treated medically with 5 mg oxycodone as needed/oral from (b)(6)2024.It was further reported that the event of constipation was not related to the therasphere device and not related to the therasphere procedure.
Additional Manufacturer Narrative
The vial lot number was not provided by the clinical study.D3: manufacturer zip/postal code: (b)(6).G1: mfr site zip/post code: (b)(6).

• Brand Name: THERASPHERE Y-90 (11 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: 21212223
• Report Number: 2124215-2025-02948
• Device Sequence Number: 15493085
• Product Code: NAW
• UDI-Device Identifier: 05060116921533
• UDI-Public: 05060116921533
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: 12/27/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/06/2025
• 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: 91 KG
• Patient Race: White