MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (5 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	Hyperbilirubinemia (1903); Liver Damage/Dysfunction (1954); Low White Blood Cell Count (4433); Thrombosis/Thrombus (4440)
Date of Event	12/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 - age at time of event: the subject was 78 years old at the time of study enrollment.
Event or Problem Description
It was reported via clinical study that the subject experienced thrombosis requiring medication.The subject was enrolled into the study on (b)(6) 2024.Pre-treatment maa (macroaggregated albumin) imaging documented a significantly higher perfusion of maa on tumors.Lung shunt calculation was 5.8%.On (b)(6) 2024, the first treatment with therasphere was performed.Therasphere administered to the liver was multiple selective through the radial artery.Two dose vials were administered.Total administered activity dose was 2.35 gbq.Post treatment dosimetry documented between random activity distribution and avid uptake in target lesion distribution of y90 on tumors.Lung dose calculation was 7.6%.On (b)(6) 2024, the second treatment with therasphere was performed.One dose vial was administered.-pre-treatment maa imaging documented an avid uptake in target lesion, dose to perfused liver was 400 gy.Lung shunt calculation was 9.89%.Therasphere administered to the liver was multiple selective through the radial artery.Total administered activity dose was 2.21 gbq.Post treatment dosimetry documented between random activity distribution and avid uptake in target lesion distribution of y90 on tumors.Dose to perfused liver was 2635 gy and dose to total normal tissue was 39.6 gy.Lung dose calculation was 10.85%.On (b)(6) 2024, 59 days post second therasphere administration, the subject was noted with portal thrombosis.The thrombosis was managed medically with 60mg of enoxaparin sodium administered subcutaneously twice daily, starting from (b)(6) 2024 and was ongoing.On (b)(6) 2024, 61 days post second therasphere administration, the subject was noted with increased bilirubin levels.No action was taken to treat the event.
Additional Manufacturer Narrative
A2 - age at time of event: the subject was 78 years old at the time of study enrollment.
Event or Problem Description
It was reported via clinical study that the subject experienced thrombosis requiring medication.The subject was enrolled into the study on (b)(6) 2024.Pre-treatment maa (macroaggregated albumin) imaging documented a significantly higher perfusion of maa on tumors.Lung shunt calculation was 5.8%.On (b)(6) 2024, the first treatment with therasphere was performed.Therasphere administered to the liver was multiple selective through the radial artery.Two dose vials were administered.Total administered activity dose was 2.35 gbq.Post treatment dosimetry documented between random activity distribution and avid uptake in target lesion distribution of y90 on tumors.Lung dose calculation was 7.6%.On (b)(6) 2024, the second treatment with therasphere was performed.One dose vial was administered.-pre-treatment maa imaging documented an avid uptake in target lesion, dose to perfused liver was 400 gy.Lung shunt calculation was 9.89%.Therasphere administered to the liver was multiple selective through the radial artery.Total administered activity dose was 2.21 gbq.Post treatment dosimetry documented between random activity distribution and avid uptake in target lesion distribution of y90 on tumors.Dose to perfused liver was 2635 gy and dose to total normal tissue was 39.6 gy.Lung dose calculation was 10.85%.On (b)(6) 2024, 59 days post second therasphere administration, the subject was noted with portal thrombosis.The thrombosis was managed medically with 60mg of enoxaparin sodium administered subcutaneously twice daily, starting from (b)(6) 2024 and was ongoing.On (b)(6) 2024, 61 days post second therasphere administration, the subject was noted with increased bilirubin levels.No action was taken to treat the event.It was further reported that the thrombosis was within the left branch of the portal vein.On (b)(6) 2024, the subject was noted with increased levels of ldh and lymphopenia.No action was taken to treat the events.The lymphopenia was resolved on (b)(6) 2024.On (b)(6) 2024, the subject was noted with lymphopenia.No action was taken to treat the event.The event was resolved on (b)(6) 2024.On (b)(6) 2024, the subject was noted with lymphopenia.No action was taken to treat the event.On (b)(6) 2025, the subject was noted with lymphopenia.No action was taken to treat the event.

• Brand Name: THERASPHERE Y-90 (5 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: 21318090
• Report Number: 2124215-2025-02658
• Device Sequence Number: 18317011
• Product Code: NAW
• UDI-Device Identifier: 05060116920291
• UDI-Public: (01)05060116920291
• 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
• Report Date (Section B): 04/02/2025

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: 01/08/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 04/02/2025
• 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 Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White