MAUDE Adverse Event Report: BWXT Y-90 THERASPHERE (10 GBQ) EUROPE; MICROSPHERES RADIONUCLIDE

Model Number 2361-02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Inflammation (1932)

Event Date 02/15/2022

Event Type  Injury  

Event Description

It was reported that this patient was hospitalized and treated for inflammation of the lung.Y-90 therasphere therapy was selected to treat cancer in the right lobe of the liver of this patient.The tc-99m macroaggregated albumin (maa) screening performed prior to the therasphere treatment indicated the patient had a lung shunt fraction of 13.7%.Four vials were ordered for this patient; 10gbq, 10.5gbq and two 20gbq.In the second week, y-90 therasphere 10.5gbq vial was used to treat the tumor with the target volume of 243.1cc.The other three vials were used to treat the tumor with the target volume of 1128.7cc.Approximately two months after treatment, the patient was admitted to the hospital with symptoms of shortness of breath.An magnetic resonance imaging (mri) was performed that showed inflammation of the lung, and the patient was treated with a high dose of steroids for two weeks.The patient was discharged from the hospital and continued to improve.

Manufacturer Narrative

(manufacturer state)= (b)(6).

• Brand Name: Y-90 THERASPHERE (10 GBQ) EUROPE
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BWXT; 447 march road; kanata K2K 1 X8; CA K2K 1X8
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus prk; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13774465
• MDR Text Key: 287254360
• Report Number: 2134265-2022-02867
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 78 KG