MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (11.5 GBQ); MICROSPHERES RADIONUCLIDE

Model Number	2361-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ventilator Dependent (2395); Loss of consciousness (2418); Obstruction/Occlusion (2422); Ischemia Stroke (4418); Respiratory Insufficiency (4462)
Date of Event	11/11/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
D3, manufacturer zip/postal: gu9 8ql.G1, mfr site zip/post code: gu9 8ql.
Event or Problem Description
It was reported that the patient experienced a stroke and passed away.This patient was enrolled in the emerald y-90 study and treated with therasphere on (b)(6) 2024.The therasphere treatment went smoothly and exactly as planned via left radial artery approach.After treatment, the site removed the catheters and put the radial band on.During this process, the patient started breathing abnormally and became unresponsive.The patient was intubated for airway protection and taken to the medical intensive care unit (icu).Computed tomography (ct) was performed of the head and the chest/abdomen/pelvis with nothing notable.Magnetic resonance imaging (mri) and magnetic resonance angiography (mra) of the head revealed a basilar artery occlusion and large posterior circulation stroke, thus a thrombectomy was performed successfully.The patient's prognosis was poor and clinically unimproved after the thrombectomy.The patient was placed on comfort care, but ultimately the family made the decision to place on do not resuscitate / do not intubate (dnr/dni) and terminally extubated.The patient passed away (b)(6) 2024.

• Brand Name: THERASPHERE Y-90 (11.5 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 ; UK
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20864517
• Report Number: 2124215-2024-76697
• Device Sequence Number: 15601279
• Product Code: NAW
• UDI-Device Identifier: 05060116921540
• UDI-Public: 05060116921540
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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: 2361-03
• Device Catalogue Number: 2361-03
• 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: 11/12/2024
• Initial Report FDA Received Date: 12/06/2024
• 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; Death
• Patient Sex: Unknown