MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (3 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 Code	Vomiting (2144)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: the subject was 62 years old at the time of study enrollment.A4 - weight: 76.2 kg.D3 & g1 - manufacturer address 1: chapman house, farnham bus park.D3 & g1 - manufacturer zip/postal code: gu9 8ql.
Event or Problem Description
Rowan clinical study: it was reported that the subject experienced vomiting requiring prescription medication.On (b)(6) 2024, treatment with therasphere was performed.Therasphere was administered to the liver selective through the femoral artery.Three dose vials were administered.Total administered activity was 4.29 gbq.Post treatment dosimetry documented avid uptake in target lesion distribution of y-90 on tumors.Lung dose calculation was 8.6 gy.On (b)(6) 2024, one day post therasphere administration, the subject experienced vomiting.The event was treated with levogastrol (25mg/ daily).
Event or Problem Description
Rowan clinical study.It was reported that the subject experienced vomiting requiring prescription medication.On (b)(6) 2024, treatment with therasphere was performed.Therasphere was administered to the liver selective through the femoral artery.Three dose vials were administered.Total administered activity was 4.29 gbq.Post treatment dosimetry documented avid uptake in target lesion distribution of y-90 on tumors.Lung dose calculation was 8.6 gy.On (b)(6) 2024, one day post therasphere administration, the subject experienced vomiting.The event was treated with levogastrol (25mg/ daily).It was further reported that the vomiting resolved on (b)(6) 2024.
Additional Manufacturer Narrative
Amended fields: b5.H6 - evaluation method codes, evaluation conclusion codes.A1 - patient identifier: (b)(6).A2 - age at time of event: the subject was 62 years old at the time of study enrollment.A4 - weight: 76.2 kg.
Event or Problem Description
It was reported that the subject experienced vomiting requiring prescription medication.On (b)(6) 2024, treatment with therasphere was performed.Therasphere was administered to the liver selective through the femoral artery.Three dose vials were administered.Total administered activity was 4.29 gbq.Post treatment dosimetry documented avid uptake in target lesion distribution of y-90 on tumors.Lung dose calculation was 8.6 gy.On (b)(6) 2024, one day post therasphere administration, the subject experienced vomiting.The event was treated with levogastrol (25mg/ daily).It was further reported that the vomiting resolved on (b)(6) 2024.It was further reported that the vomiting resolved on (b)(6) 2024, previously reported to have resolved on (b)(6) 2024.
Additional Manufacturer Narrative
Amended fields: b5.A2 - age at time of event: the subject was 62 years old at the time of study enrollment.A4 - weight: 76.2 kg.

• Brand Name: THERASPHERE Y-90 (3 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: 20737959
• Report Number: 2124215-2024-72485
• Device Sequence Number: 20994881
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2025

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: 11/06/2024
• Supplement Date Received by Manufacturer: 12/05/2024; 08/21/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/16/2024; 09/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERASPHERE Y-90 (3 GBQ) CE MARK.; THERASPHERE Y-90 (3 GBQ) CE MARK.; THERASPHERE Y-90 (3 GBQ) CE MARK.; THERASPHERE Y-90 (4 GBQ) CE MARK.; THERASPHERE Y-90 (4 GBQ) CE MARK.; THERASPHERE Y-90 (4 GBQ) CE MARK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White