MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (8 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	Fatigue (1849); Nausea (1970); Pain (1994)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Rowan clinical study.It was reported that the patient experienced nausea requiring a prescription medication.The subject was enrolled into rowan study on (b)(6) 2024.Pre-treatment macroaggregated albumin (maa) imaging [prior to 1st therasphere treatment] details of perfusion of maa on tumors was not available, dose to perfused liver was 275.8 gy, and dose to total normal tissue was 32.9 gy.Lung shunt calculation was 1.8%.On (b)(6) 2024, the treatment with therasphere was performed.Therasphere administered to the liver was selective (<=2 segments in the perfused volume), and 1 dose vial was administered; total administered activity dose is 2.88 gbq.Post treatment dosimetry documented avid uptake in target lesion distribution of y90 on tumors.Dose to perfused liver was 413 gy; dose to total normal tissue was 37.5 gy.Lung dose calculation was 2.6%.On (b)(6) 2024, combination therapy with 1500 mg durvalumab followed by 300 mg of tremelimumab were administered intravenously.On (b)(6) 2024, 14 days post the therasphere administration, the subject presented with pain, nausea, and fatigue.The subject was treated with zofran for nausea.No other actions were taken to treat fatigue or pain.
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).D3: manufacturer address 1: chapman house, farnham bus park.D3: manufacturer zip/postal code: gu9 8ql.G1: mfr site address 1: chapman house, farnham bus park.G1: mfr site zip/post code: gu9 8ql.
Additional Manufacturer Narrative
A1: patient identifier:(b)(6).(b)(4).
Event or Problem Description
Rowan clinical study.It was reported that the patient experienced nausea requiring a prescription medication.The subject was enrolled into rowan study on (b)(6) 2024.Pre-treatment macroaggregated albumin (maa) imaging [prior to 1st therasphere treatment] details of perfusion of maa on tumors was not available, dose to perfused liver was 275.8 gy, and dose to total normal tissue was 32.9 gy.Lung shunt calculation was 1.8%.On (b)(6) 2024 the treatment with therasphere was performed.Therasphere administered to the liver was selective (<=2 segments in the perfused volume), and 1 dose vial was administered; total administered activity dose is 2.88 gbq.Post treatment dosimetry documented avid uptake in target lesion distribution of y90 on tumors.Dose to perfused liver was 413 gy; dose to total normal tissue was 37.5 gy.Lung dose calculation was 2.6%.On (b)(6) 2024, combination therapy with 1500 mg durvalumab followed by 300 mg of tremelimumab were administered intravenously.On (b)(6) 2024, 14 days post the therasphere administration, the subject presented with pain, nausea, and fatigue.The subject was treated with zofran for nausea.No other actions were taken to treat fatigue or pain.

• Brand Name: THERASPHERE Y-90 (8 GBQ) US
• Common Device Name: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; weydon lane; farnham, surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; weydon lane; farnham, surrey ; UK
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19037693
• Report Number: 2124215-2024-20265
• Device Sequence Number: 20581072
• Product Code: NAW
• UDI-Device Identifier: 05060116921472
• UDI-Public: 05060116921472
• 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): 04/26/2024

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
• Device Lot Number: 2499072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Race: White