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 Code	Ascites (2596)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was enrolled in the investigator initiated study, immuwhy.It was reported that the patient had ascites requiring hospitalization post therasphere procedure.Immuwhy is a phase ii 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 are scheduled to receive y-90 sirt therapy as standard of care.This patient underwent sirt with therasphere administration on (b)(6) 2023.On (b)(6) durvalumab and tremelimumab were given.On (b)(6) 2023, the patient had ascites and was hospitalized.The patient was symptomatic with medical intervention indicated; the drainage was changed.The patient was discharged on (b)(6) 2023, and the event was considered resolved.
Additional Manufacturer Narrative
A2: date of birth: 1944.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.

• 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: 18320684
• Report Number: 2124215-2023-68150
• Device Sequence Number: 18022522
• 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
• Report Date (Section B): 12/13/2023

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: 2399355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 12/13/2023
• 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; Hospitalization
• Patient Sex: Female
• Patient Weight: 63 KG