MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (6 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); Liver Damage/Dysfunction (1954); Nausea (1970); Constipation (3274); Decreased Appetite (4569); Insufficient Information (4580)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via study that the subject experienced nausea and abdominal pain requiring prescription medication, hospitalization, and additional intervention.The subject was enrolled in the study on (b)(6) 2024.Pre-treatment maa imaging documented a significantly higher perfusion of maa on tumors.Lung shunt calculation was 2 %.On (b)(6) 2024, the treatment with therasphere was performed.Therasphere was administered to selective through femoral artery.Two dose vials were administered, on (b)(6) 2024, the subject experienced an increase in aspartate aminotransferase and constipation.Miralax was administered to treat the constipation.On (b)(6) 2024, the subject experienced an increase in gamma-glutamyl transferase (ggt), alkaline phosphatase, and alanine aminotransferase (alt).No action was taken to treat the events.On (b)(6) 2024, the subject experienced fatigue, abdominal pain, and weight loss.Tramadol was administered to treat the abdominal pain.On (b)(6) 2024, the subject experienced intermittent nausea.Zofran was administered to treat the nausea.On (b)(6) 2025, the subject experienced anorexia and dry mouth.No action was taken to treat the events.On (b)(6) 2025, the subject experienced an increase in alanine aminotransferase.Medical or surgical intervention was performed to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function in response to the event.Additionally, the subject experienced an increase in aspartate aminotransferase and ggt.Prednisone was administered to treat the increase in aspartate aminotransferase.On (b)(6) 2025, the subject was noted with alt elevation from prednisone use that required administration of iv steroids, which led to the hospitalization of the subject on (b)(6) 2025.
Additional Manufacturer Narrative
A2 - age at time of event: the subject was 67 years old at the time of study enrollment.A4 - weight: 110.6 kg.H6 - patient code(s): e2401 insufficient information was used to capture the reported patient event of "dry mouth".
Event or Problem Description
It was reported via study that the subject experienced nausea and abdominal pain requiring prescription medication, hospitalization, and additional intervention.The subject was enrolled in the study on (b)(6) 2024.Pre-treatment maa imaging documented a significantly higher perfusion of maa on tumors.Lung shunt calculation was 2 %.On (b)(6) 2024, the treatment with therasphere was performed.Therasphere was administered to selective through femoral artery.Two dose vials were administered, on (b)(6) 2024, the subject experienced an increase in aspartate aminotransferase and constipation.Miralax was administered to treat the constipation.On (b)(6) 2024, the subject experienced an increase in gamma-glutamyl transferase (ggt), alkaline phosphatase, and alanine aminotransferase (alt).No action was taken to treat the events.On (b)(6) 2024, the subject experienced fatigue, abdominal pain, and weight loss.Tramadol was administered to treat the abdominal pain.On (b)(6) 2024, the subject experienced intermittent nausea.Zofran was administered to treat the nausea.On (b)(6) 2025, the subject experienced anorexia and dry mouth.No action was taken to treat the events.On (b)(6) 2025, the subject experienced an increase in alanine aminotransferase.Medical or surgical intervention was performed to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function in response to the event.Additionally, the subject experienced an increase in aspartate aminotransferase and ggt.Prednisone was administered to treat the increase in aspartate aminotransferase.On (b)(6) 2025, the subject was noted with alt elevation from prednisone use that required administration of iv steroids, which led to the hospitalization of the subject on (b)(6) 2025.It was further reported that the total therasphere administration dose during the index procedure was 5.512 gbq across two dose vials.Additionally, it was reported that the increased alanine aminotransferase was medically treated with cellcept.The increases in alanine aminotransferase and aspartate aminotransferase were treated with methylprednisolone.There is no longer an allegation that the dry mouth was related to either the therasphere device or procedure.On (b)(6) 2025, the subject was discharged from the hospital.
Additional Manufacturer Narrative
A2 - age at time of event: the subject was 67 years old at the time of study enrollment.A4 - weight: 110.6 kg.H6 - patient code(s): the code e2401 insufficient information was removed, as there is no longer an allegation that the event of "dry mouth" was related to the therasphere device or procedure.Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported via study that the subject experienced nausea and abdominal pain requiring prescription medication, hospitalization, and additional intervention.The subject was enrolled in the study on (b)(6) 2024.Pre-treatment maa imaging documented a significantly higher perfusion of maa on tumors.Lung shunt calculation was 2 %.On (b)(6) 2024, the treatment with therasphere was performed.Therasphere was administered to selective through femoral artery.Two dose vials were administered, on (b)(6) 2024, the subject experienced an increase in aspartate aminotransferase and constipation.Miralax was administered to treat the constipation.On (b)(6) 2024, the subject experienced an increase in gamma-glutamyl transferase (ggt), alkaline phosphatase, and alanine aminotransferase (alt).No action was taken to treat the events.On (b)(6) 2024, the subject experienced fatigue, abdominal pain, and weight loss.Tramadol was administered to treat the abdominal pain.On (b)(6) 2024, the subject experienced intermittent nausea.Zofran was administered to treat the nausea.On (b)(6) 2025, the subject experienced anorexia and dry mouth.No action was taken to treat the events.On (b)(6) 2025, the subject experienced an increase in alanine aminotransferase.Medical or surgical intervention was performed to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function in response to the event.Additionally, the subject experienced an increase in aspartate aminotransferase and ggt.Prednisone was administered to treat the increase in aspartate aminotransferase.On (b)(6) 2025, the subject was noted with alt elevation from prednisone use that required administration of iv steroids, which led to the hospitalization of the subject on (b)(6) 2025.It was further reported that the total therasphere administration dose during the index procedure was 5.512 gbq across two dose vials.Additionally, it was reported that the increased alanine aminotransferase was medically treated with cellcept.The increases in alanine aminotransferase and aspartate aminotransferase were treated with methylprednisolone.There is no longer an allegation that the dry mouth was related to either the therasphere device or procedure.On (b)(6) 2025, the subject was discharged from the hospital.It was further reported that the events of intermittent nausea and anorexia were resolved on (b)(6) 2025.Additionally, the total therasphere administration dose was updated to 6.21 gbq.
Additional Manufacturer Narrative
A2 - age at time of event: the subject was 67 years old at the time of study enrollment.A4 - weight: 110.6 kg h6 - patient code(s): the code e2401 insufficient information was removed, as there is no longer an allegation that the event of "dry mouth" was related to the therasphere device or procedure.Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported via study that the subject experienced nausea and abdominal pain requiring prescription medication, hospitalization, and additional intervention.The subject was enrolled in the study on (b)(6) 2024.Pre-treatment maa imaging documented a significantly higher perfusion of maa on tumors.Lung shunt calculation was 2 %.On (b)(6) 2024, the treatment with therasphere was performed.Therasphere was administered to selective through femoral artery.Two dose vials were administered, on (b)(6) 2024, the subject experienced an increase in aspartate aminotransferase and constipation.Miralax was administered to treat the constipation.On (b)(6) 2024, the subject experienced an increase in gamma-glutamyl transferase (ggt), alkaline phosphatase, and alanine aminotransferase (alt).No action was taken to treat the events.On (b)(6) 2024, the subject experienced fatigue, abdominal pain, and weight loss.Tramadol was administered to treat the abdominal pain.On (b)(6) 2024, the subject experienced intermittent nausea.Zofran was administered to treat the nausea.On (b)(6) 2025, the subject experienced anorexia and dry mouth.No action was taken to treat the events.On (b)(6) 2025, the subject experienced an increase in alanine aminotransferase.Medical or surgical intervention was performed to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function in response to the event.Additionally, the subject experienced an increase in aspartate aminotransferase and ggt.Prednisone was administered to treat the increase in aspartate aminotransferase.On (b)(6) 2025, the subject was noted with alt elevation from prednisone use that required administration of iv steroids, which led to the hospitalization of the subject on (b)(6) 2025.It was further reported that the total therasphere administration dose during the index procedure was 5.512 gbq across two dose vials.Additionally, it was reported that the increased alanine aminotransferase was medically treated with cellcept.The increases in alanine aminotransferase and aspartate aminotransferase were treated with methylprednisolone.There is no longer an allegation that the dry mouth was related to either the therasphere device or procedure.On (b)(6) 2025, the subject was discharged from the hospital.It was further reported that the events of intermittent nausea and anorexia were resolved on (b)(6) 2025.Additionally, the total therasphere administration dose was updated to 6.21 gbq.It was further reported that the onset date for the increase in ggt was (b)(6) 2024, previously reported to be (b)(6) 2024.Furthermore, the increases in alanine aminotransferase and aspartate aminotransferase noted on (b)(6) 2025 were no longer suspected to have been related to the therasphere device or procedure.
Additional Manufacturer Narrative
Amended fields: b5 - describe event or problem.A2 - age at time of event: the subject was 67 years old at the time of study enrollment.A4 - weight: 110.6 kg.Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.

• Brand Name: THERASPHERE Y-90 (6 GBQ) US
• 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: 21463343
• Report Number: 2124215-2025-11137
• Device Sequence Number: 8750230
• Product Code: NAW
• UDI-Device Identifier: 05060116921434
• UDI-Public: (01)05060116921434
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2025

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: 01/28/2025
• Supplement Date Received by Manufacturer: 03/14/2025; 05/13/2025; 08/22/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/10/2025; 06/10/2025; 09/18/2025
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 110 KG