MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (9 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	Liver Damage/Dysfunction (1954); Ascites (2596)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D3: manufacturer zip/postal code: gu9 8ql.G1: mfr site zip/post code: gu9 8ql.The vial lot number was not provided by the study.
Event or Problem Description
It was reported via clinical study that the patient had ascites, requiring intervention.Prior to treatment, advanced, multicompartment dosimetry was performed to assess treatment dose.Vascular access was obtained through the femoral artery.99mtc-macroaggregated albumin (maa) infusion was performed during the pre-treatment angiography.Catheter position for the 99mtc-maa infusion was right hepatic artery (irrespective of origin) (segments v/vi/vii/viii).Single photon emission computed tomography (spect / ct) was performed as a post 99mtc-maa 3d imaging which revealed significantly higher overall perfusion in tumour versus normal liver and intermediate distribution (99mtc-maa distribution in 50 - < 98% of the tumour volume).On (b)(6) 2023, the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.Type of therasphere infusion was right liver.The catheter was positioned at right hepatic artery (irrespective of origin) (segments v/vi/vii/viii).4.756 gbq was administered to the right liver through vial 1.On (b)(6) 2023, 108 days post index procedure, the subjected was diagnosed with ascites.This event resulted in a permanent impairment of a body structure or a body function of the subject.Surgery or interventional radiology procedure was performed to treat the event.On (b)(6) 2024, during the follow up visit, ecog score was assessed to be 2.Encephalopathy was assessed as 0 and ascites score was assessed as 3 (severe clinical or imaging); clinically symptomatic, paracentesis needed and diuretic treatment.Child-pugh score assessed as b8.
Additional Manufacturer Narrative
B3: date of event was updated due to additional information received.D3: manufacturer zip/postal code: (b)(6).G1: mfr site zip/post code: (b)(6).The vial lot number was not provided by the study.
Event or Problem Description
It was reported via clinical study that the patient had ascites, requiring intervention.Prior to treatment, advanced, multicompartment dosimetry was performed to assess treatment dose.Vascular access was obtained through the femoral artery.99mtc-macroaggregated albumin (maa) infusion was performed during the pre-treatment angiography.Catheter position for the 99mtc-maa infusion was right hepatic artery (irrespective of origin) (segments v/vi/vii/viii).Single photon emission computed tomography (spect / ct) was performed as a post 99mtc-maa 3d imaging which revealed significantly higher overall perfusion in tumour versus normal liver and intermediate distribution (99mtc-maa distribution in 50 - < 98% of the tumour volume).On (b)(6) 2023, the subject was enrolled into a clinical study and the treatment with therasphere was performed on the same day.Type of therasphere infusion was right liver.The catheter was positioned at right hepatic artery (irrespective of origin) (segments v/vi/vii/viii).4.756 gbq was administered to the right liver through vial 1.On (b)(6) 2023, 108 days post index procedure, the subjected was diagnosed with ascites.This event resulted in a permanent impairment of a body structure or a body function of the subject.Surgery or interventional radiology procedure was performed to treat the event.On (b)(6) 2024, during the follow up visit, ecog score was assessed to be 2.Encephalopathy was assessed as 0 and ascites score was assessed as 3 (severe clinical or imaging); clinically symptomatic, paracentesis needed and diuretic treatment.Child-pugh score assessed as b8.It was further reported that on (b)(6) 2023, 106 days post index procedure, the subject presented to the hospital due to oedemato-ascitic decompensation.On the same day, the subject was admitted to the hospital due to serious deterioration of health and was diagnosed with ascites.Diuretic treatment and dose adjustments were performed with recurrent ascites puncture (approximately every 10 days).On (b)(6) 2023, the subject was discharged from the hospital.

• Brand Name: THERASPHERE Y-90 (9 GBQ) CE MARK
• 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 ; UK
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21472727
• Report Number: 2124215-2025-11811
• Device Sequence Number: 14325587
• Product Code: NAW
• UDI-Device Identifier: 05060116920437
• UDI-Public: (01)05060116920437
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 06/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 88 KG