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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/19/2023
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 esophageal varices hemorrhage after selective internal radiation therapy (sirt).Immuwhy is a phase ii study of immunotherapy with durvalumab and tremelimumab 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 5gbq therasphere administration on (b)(6) 2023.On (b)(6) 2023, 1500 mg of durvalumab and 3000 mg of tremelimumab were given.On (b)(6) 2023, the patient had esophageal varices hemorrhage and was hospitalized.A blood transfusion was performed.
Additional Manufacturer Narrative
D3: manufacturer address 1: chapman house, farnham bus park.D3; manufacturer state: on.D3: manufacturer zip/postal code: gu9 8ql.G1: mfr site address 1: chapman house, farnham bus park.G1: mfr site state: on.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 esophageal varices hemorrhage after selective internal radiation therapy (sirt).Immuwhy is a phase ii study of immunotherapy with durvalumab and tremelimumab 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 5gbq therasphere administration on (b)(6) 2023.On (b)(6) 2023, 1500 mg of durvalumab and 3000 mg of tremelimumab were given.On (b)(6) 2023, the patient had esophageal varices hemorrhage and was hospitalized.A blood transfusion was performed.
Additional Manufacturer Narrative
D4: lot number: based on the facility and the procedure date, the most likely batch numbers are either 2399349 or 2399355.D3: manufacturer address 1: chapman house, farnham bus park.D3; manufacturer state: on.D3: manufacturer zip/postal code: gu9 8ql.G1: mfr site address 1: chapman house, farnham bus park.G1: mfr site state: on.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 esophageal varices hemorrhage after selective internal radiation therapy (sirt).Immuwhy is a phase ii study of immunotherapy with durvalumab and tremelimumab 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 5gbq therasphere administration on (b)(6) 2023.On(b)(6) 2023, 1500 mg of durvalumab and 3000 mg of tremelimumab were given.On (b)(6) 2023, the patient had esophageal varices hemorrhage and was hospitalized.A blood transfusion was performed.It was further reported that the patient was discharged on (b)(6) 2023, and the event was considered resolved.
Additional Manufacturer Narrative
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.
Event or Problem Description
The patient was enrolled in the investigator initiated study, (b)(6).It was reported that the patient had esophageal varices hemorrhage after selective internal radiation therapy (sirt).Immuwhy is a phase ii study of immunotherapy with durvalumab and tremelimumab 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 5gbq therasphere administration on 02 august 2023.On (b)(6) 2023, 1500 mg of durvalumab and 3000 mg of tremelimumab were given.On (b)(6) 2023, the patient had esophageal varices hemorrhage and was hospitalized.A blood transfusion was performed.
Additional Manufacturer Narrative
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: 17660432
• Report Number: 2124215-2023-46327
• Device Sequence Number: 17914162
• 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,Followup,Followup
• Report Date (Section B): 12/11/2023

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: 08/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023; 10/31/2023; 11/29/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/18/2023; 11/29/2023; 12/11/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 75 KG