MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (9.5 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	Fever (1858)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Proactif clinical study.It was reported that the patient developed a persistent fever requiring hospitalization.Advanced, multicompartment dosimetry was performed to assess the treatment dose.Per-treatment tc-maa (technetium macroaggregated albumin) uptake by the perfused liver was 160 gy and perfused tumor was 190 gy.On 08-march-2023, the subject was enrolled into the proactif study and treatment with therasphere was performed on the same day.The therasphere infusion site was selective.The catheter was positioned in the accessory right hepatic artery (segments vi/vii): 3.2 gbq of therasphere was administered to the selective liver through vial 1.Post treatment dosimetry documented a strong uptake of the delivered dose to perfused liver, which was 151 gy and to the perfused tumor was 164 gy.On (b)(6) 2023, 2 days post index procedure, the subject developed persistent fever.On (b)(6) 2023, the subject was admitted to the hospital for further evaluation and treatment.Fever developed post chemotherapy and radioembolization.The subject was treated with concomitant medication.A ct scan revealed no sign of perforation and surinfection (secondary infection); blood culture was sterile.On (b)(6) 2023, the event was considered to be resolved.Hence, a decision was made to stop chemotherapy and no gemzar medication was administered.On (b)(6) 2023, the subject was noted to be feverless.On (b)(6) 2023, the subject was discharged from the hospital.
Additional Manufacturer Narrative
A2: date of birth: born in 1958.D3: manufacturer address 1: chapman house, farnham bus park.G1: mfr site address 1: chapman house, farnham bus park.G1: mfr site zip/post code: gu9 8ql.
Additional Manufacturer Narrative
Updated: b5 describe event or problem; d4 model number, lot number, catalog number, unique, identifier (udi) #; d6 implant date; h6 evaluation method codes, evaluation result codes, evaluation conclusion codes.A2: date of birth: born in 1958.D3: manufacturer address 1: chapman house, farnham bus park, g1: mfr site address 1: chapman house, farnham bus park, g1: mfr site zip/post code: gu9 8ql.
Event or Problem Description
Proactif clinical study.It was reported that the patient developed a persistent fever requiring hospitalization.Advanced, multicompartment dosimetry was performed to assess the treatment dose.Per-treatment tc-maa (technetium macroaggregated albumin) uptake by the perfused liver was 160 gy and perfused tumor was 190 gy.On (b)(6) 2023, the subject was enrolled into the proactif study and treatment with therasphere was performed on the same day.The therasphere infusion site was selective.The catheter was positioned in the accessory right hepatic artery (segments vi/vii): 3.2 gbq of therasphere was administered to the selective liver through vial 1.Post treatment dosimetry documented a strong uptake of the delivered dose to perfused liver, which was 151 gy and to the perfused tumor was 164 gy.On (b)(6) 2023, 1 day post index procedure, the subject developed persistent fever.On (b)(6) 2023, the subject was admitted to the hospital for further evaluation and treatment.Fever developed post chemotherapy and radioembolization.The subject was treated with concomitant medication.A ct scan revealed no sign of perforation and surinfection (secondary infection); blood culture was sterile.On (b)(6) 2023, the event was considered to be resolved.Hence, a decision was made to stop chemotherapy and no gemzar medication was administered.On (b)(6) 2023, the subject was noted to be feverless.On (b)(6)2023, the subject was discharged from the hospital.

• Brand Name: THERASPHERE Y-90 (9.5 GBQ) CE MARK
• Common Device Name: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• 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: 16817439
• Report Number: 2124215-2023-17208
• Device Sequence Number: 16626780
• Product Code: NAW
• UDI-Device Identifier: 05060116920444
• UDI-Public: 05060116920444
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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: 2399103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/21/2024
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 80 KG