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

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

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Event date is unknown.Implant date is unknown.

Event Description

It was reported via journal article that patient complications occurred.The study consisted of patients with hepatocellular carcinoma (hcc) patients with cholangiocarcinoma or combined hepatocarcinoma-cholangiocarcinoma were excluded.The inclusion started at august 2006 and finished at may 2016.The follow-up ended in november 2020.Patients underwent pretreatment assessment, including clinical history, physical examination, and laboratory and baseline imaging studies.The decision to treat patients with y90 as part of this study was made by consensus at weekly multidisciplinary hcc conference composed of staff from hepatology, medical oncology, hepatobiliary and transplant surgery, and diagnostic and interventional radiology.The procedure was conducted according to experts recommendation revised elsewhere.Patients were discharged from the hospital 24 hours after the procedure unless unexpected complications.Three patients experimented treated-related complications: actinic cholecystitis (n=1), transient liver decompensation (n=1) and celiac trunk dissection (n=1).No treatment-related deaths were registered.

• 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
• MDR Report Key: 11627052
• MDR Text Key: 260982509
• Report Number: 3002124543-2021-00009
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention