MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (10.5 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	Pleural Effusion (2010); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was enrolled in the investigator-initiated study, immuwhy.It was reported that the patient had pleural effusion.Immuwhy is a phase ii study of immunotherapy with durvalumab, or durvalumab and tremelimumab both, combined with y-90 selective internal radiation therapy (sirt) in patients with advanced stage intrahepatic biliary tract cancer (btc) and are scheduled to receive y-90 sirt therapy as standard of care.This patient underwent sirt with therasphere administration on (b)(6) 2023.The patient received durvalumab on (b)(6) 2023 and a third cycle was administered on (b)(6) 2023.On (b)(6) 2024, the patient had pleural effusion and was hospitalized.A pleural puncture was performed.The patient will be transferred to another hospital for further treatment and surgery.
Additional Manufacturer Narrative
A2: age at time of event: year of birth 1944.D3: manufacturer address 1: chapman house, farnham bus park.D3: manufacturer zip/postal code: gu9 8ql.E1: initial reporter phone number: (b)(6).G1: mfr site address 1: chapman house, farnham bus park.G1: mfr site zip/post code: gu9 8ql.
Event or Problem Description
The patient was enrolled in the investigator-initiated study, immuwhy.It was reported that the patient had pleural effusion.Immuwhy is a phase ii study of immunotherapy with durvalumab, or durvalumab and tremelimumab both, combined with y-90 sirt therapy in patients with advanced stage intrahepatic biliary tract cancer (btc) and are scheduled to receive y-90 sirt therapy as standard of care.This patient received durvalumab and underwent sirt with therasphere administration on (b)(6) 2023.On (b)(6) 2024 the patient had pleural effusion and was hospitalized.A pleural puncture was performed.The patient will be transferred to another hospital for further treatment and surgery.It was further reported that the pleural effusion was resolved with sequelae on (b)(6) 2024; however, the event of pleural effusion was assessed as unrelated to the therasphere device and unrelated to the procedure per the investigator.
Additional Manufacturer Narrative
A2: age at time of event: year of birth 1944.(b)(4).

• Brand Name: THERASPHERE Y-90 (10.5 GBQ) CE MARK
• 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: 18591404
• Report Number: 2124215-2024-03138
• Device Sequence Number: 6726556
• Product Code: NAW
• UDI-Device Identifier: 05060116920451
• UDI-Public: 05060116920451
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/28/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2361-02
• Device Catalogue Number: 2361-02
• Device Lot Number: 2399355
• 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: 01/10/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/28/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 60 KG