MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (7 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	Pulmonary Embolism (1498); Abdominal Pain (1685); Pain (1994)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event estimated using date therasphere was administered.Event date is most likely between 03-oct-2024 (date of administration) and (b)(6) 2024 (date of first medication given in response to the event).D3: manufacturer zip/postal code: (b)(6), g1: mfr site zip/post code: (b)(6).
Event or Problem Description
It was reported via clinical study that the patient had epigastric pain and a non-obstructive pulmonary embolism, requiring prescription medication.The subject was enrolled in the clinical study on (b)(6) 2024.Pre-treatment macroaggregated albumin (maa) imaging documented avid uptake in all lesions.Thermosphere treatment administration was performed on (b)(6) 2024.On (b)(6) 2024, combination therapy with 1500 mg durvalumab followed by 300 mg of tremelimumab were administered intravenously.On (b)(6) 2024, monotherapy of 1500 mg durvalumab was administered intravenously.On (b)(6) 2024, monotherapy of 1500 mg durvalumab was administered intravenously.The subject had epigastric pain and a non-obstructive pulmonary embolism.The adverse events were treated with the following medication: acupan (20mg/ four times per day, starting (b)(6) 2024), innohep 4 000ui/0.55(1 injection/ daily, (b)(6) 2024), and eliquis (5 mg/ twice daily, starting (b)(6) 2024).
Event or Problem Description
It was reported via clinical study that the patient had epigastric pain and a non-obstructive pulmonary embolism, requiring prescription medication.The subject was enrolled in the clinical study on (b)(6) 2024.Pre-treatment macroaggregated albumin (maa) imaging documented avid uptake in all lesions.Therasphere treatment administration was performed on (b)(6) 2024.On (b)(6) 2024, combination therapy with 1500 mg durvalumab followed by 300 mg of tremelimumab were administered intravenously.On (b)(6) 2024, monotherapy of 1500 mg durvalumab was administered intravenously.On (b)(6) 2024, monotherapy of 1500 mg durvalumab was administered intravenously.The subject had epigastric pain and a non-obstructive pulmonary embolism.The adverse events were treated with the following medication: acupan (20mg/ four times per day, starting (b)(6) 2024), innohep 4 000ui/0.55 (1 injection/ daily, (b)(6) 2024), and eliquis (5 mg/ twice daily, starting (b)(6) 2024).It was further reported that the event of "non-obstructive pulmonary embolism" was a data entry error.On (b)(6) 2024, one dose vial of therasphere was administered to the liver; total administered activity dose was reported as 2.718 gbq.On the same day as therasphere administration, the subject was noted with right hypochondrium pain, which was treated with acupan (20 mg /orally/four times per day, (b)(6) 2024 through (b)(6) 2024) and efferalgan (paracetamol) (1000 mg/ orally/ as needed, (b)(6) 2024 through (b)(6) 2024).
Additional Manufacturer Narrative
D3: manufacturer zip/postal code: gu9 8ql.G1: mfr site zip/post code: gu9 8ql.

• Brand Name: THERASPHERE Y-90 (7 GBQ) CE MARK
• 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 park; weydon lane; farnham, surrey ; UK
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21369254
• Report Number: 2124215-2025-07547
• Device Sequence Number: 15562154
• Product Code: NAW
• UDI-Device Identifier: 05060116920307
• UDI-Public: 05060116920307
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/24/2025

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: 01/17/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/24/2025
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 64 KG