MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (8 GBQ) US; MICROSPHERES RADIONUCLIDE

Model Number	2361-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Rowan clinical study.It was reported that the subject experienced pain requiring diagnostic intervention and medication.The subject was enrolled into the rowan study on (b)(6) 2024.Pre-treatment imaging documented avid uptake in target lesion; dose to perfused liver was 663.2 gy.Dose to total normal tissue was 43.2 gy.Lung shunt calculation was 6.0 %.On (b)(6) 2024, treatment with therasphere was performed.Therasphere was administered to the liver through the femoral artery.Three dose vials were administered.Total administered activity dose was 7.23 gbq.Post treatment dosimetry documented avid uptake in target lesion distribution of y90 on tumors.Dose to perfused liver was 884 gy and dose to total normal tissue was 57.4 gy.Lung dose calculation was 21.7 gy.On the same day, post therasphere administration, the subject began to experience pain in the right hip to the lower extremity.After the procedure, the pi ordered a check of blood flow and started the patient on asa 325 mg.The subject was referred for an arterial evaluation.The event was treated through administration of oxycodone.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: the subject was 77 years old at the time of study enrollment.A4 - weight: 109.9 kg d3 & g1 - manufacturer address 1: chapman house, farnham bus park d3 & g1 - manufacturer zip/postal code: gu9 8ql.

• Brand Name: THERASPHERE Y-90 (8 GBQ) US
• 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: 20483700
• Report Number: 2124215-2024-65094
• Device Sequence Number: 14356335
• Product Code: NAW
• UDI-Device Identifier: 05060116921472
• UDI-Public: 05060116921472
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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: 09/23/2024
• Initial Report FDA Received Date: 10/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: THERASPHERE Y-90 (11 GBQ) US; THERASPHERE Y-90 (18.5 GBQ) US
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White