MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (5 GBQ); MICROSPHERES RADIONUCLIDE

Model Number	2361-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombocytopenia (4431)
Date of Event	02/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was enrolled in the immuwhy clinical study.It was reported the patient had prolonged hospitalization due to low platelet counts.On (b)(6) 2021, the patient was treated with therasphere 103 gy along with study medication durvalumab and tremelimumab.On (b)(6) 2021, the patient was diagnosed with thrombocytopenia/low platelet counts (grade 4) and hospitalization was prolonged for further observation.On (b)(6) 2021, the symptoms were resolving, and the patient was discharged from the hospital.
Additional Manufacturer Narrative
A2 age at time of event: year of birth 1938.E1 initial reporter address 1: (b)(6).D3, g1 manufacturer zip/postal code: gu9 8ql.
Event or Problem Description
The patient was enrolled in the immuwhy clinical study with patient identifier (b)(6).It was reported the patient had prolonged hospitalization due to low platelet counts.On (b)(6) 2021, the patient was treated with therasphere 103 gy along with study medication durvalumab and tremelimumab.On (b)(6) 2021, the patient was diagnosed with thrombocytopenia/low platelet counts (grade 4) and hospitalization was prolonged for further observation.On (b)(6) 2021, the symptoms were resolving, and the patient was discharged from the hospital.
Additional Manufacturer Narrative
A2 age at time of event: year of birth (b)(6).E1 initial reporter address 1: (b)(6).D3, g1 manufacturer zip/postal code: gu9 8ql.

• Brand Name: THERASPHERE Y-90 (5 GBQ)
• 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 GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18575937
• Report Number: 2124215-2024-03154
• Device Sequence Number: 18368423
• Product Code: NAW
• UDI-Device Identifier: 05060116920291
• UDI-Public: 05060116920291
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2361-02
• Device Catalogue Number: 2361-02
• Device Lot Number: 2199043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 03/21/2024
• 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
• Patient Sex: Female
• Patient Weight: 57 KG