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 Code	Pain (1994)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: age at time of event: year of birth 1949.E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).D3: manufacturer zip/postal code: (b)(6).G1: mfr site zip/post code: (b)(6).
Event or Problem Description
It was reported that the patient had severe back pain requiring hospitalization.The patient was enrolled in an investigator-initiated study of immunotherapy with durvalumab or durvalumab and tremelimumab, both combined with y-90 sirt therapy.The patients have advanced stage intrahepatic biliary tract cancer (btc) and receive y-90 sirt therapy as standard of care.This patient underwent sirt with therasphere administration on (b)(6) 2025.On (b)(6) 2025, durvalumab and tremelimumab were given.The patient was admitted to the hospital on (b)(6) 2025.The patient had severe back pain with limitation in activities of daily living.There was clinical worsening since therasphere administration and immunotherapy with lumbar pain.The patient was discharged from the hospital on (b)(6) 2025.

• 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 prk; weydon lane; farnham, surrey ; UK
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21643454
• Report Number: 2124215-2025-16391
• Device Sequence Number: 18035885
• Product Code: NAW
• UDI-Device Identifier: 05060116920307
• UDI-Public: 05060116920307
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 03/19/2025

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
• Device Lot Number: 2599022
• 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: 02/20/2025
• Initial Report FDA Received Date: 03/19/2025
• 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: Hospitalization
• Patient Sex: Female
• Patient Weight: 69 KG