MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES

Model Number OTT-FP-13.700

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

Patient Problem Pleural Effusion (2010)

Event Date 01/29/2021

Event Type  Death  

Manufacturer Narrative

The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The device remains implanted and will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that a patient death occurred.The patient had metastatic esophageal cancer which had been largely stable for several months, with dominant disease in his liver, which had showed progression.The patient was treated with therasphere on (b)(6) 2021.A moderate right pleural effusion was noted on the post procedure computed tomography (ct).The patient was discharged, however, the patient was admitted on (b)(6) 2021 for shortness of breath, which was assessed as the physician as almost certainly not a side effect of the treatment.The patient had documented pulmonary metastatic disease prior to the treatment and an effusion on the day of treatment, which could not have developed instantly.The effusion caused his shortness of breath, which provoked his presentation to the hospital.A thoracentesis and additional diagnostic imaging was performed.The patient entered hospice care and expired on (b)(6) 2021.The cause of death is progression of disease.

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house; farnham bus park; weydon lane, farnham, GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BTG INTERNATIONAL CANADA INC.; 11 hines road; suite 200; ottawa, ontario K2K 2 X1; CA K2K 2X1
• Manufacturer Contact: sandra bausback-aballo ; chapman house; farnham bus park; weydon lane, farnham, GU9 8-QL ; UK GU9 8QL
• MDR Report Key: 11582387
• MDR Text Key: 242731892
• Report Number: 3002124543-2021-00008
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: OTT-FP-13.700
• Device Lot Number: 2199022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death