MAUDE Adverse Event Report: BIOCOMPATIBLES LTD. Y-90 THERASPHERE (3 GBQ) CANADA COMM; MICROSPHERES RADIONUCLIDE

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

Patient Problems Abdominal Pain (1685); Encephalopathy (1833); Fatigue (1849); Fever (1858); Nausea (1970); Vomiting (2144); Ascites (2596); Constipation (3274); Decreased Appetite (4569)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Journal article: canadian journal of gastroenterology and hepatology; volume 2021, article id 9926704, 14 pages; https://doi.Org/10.1155/2021/9926704.Date of event: the date of event is not specified therefore the date of the article submission was used.

Event Description

It was reported via journal article patient complications occurred.This study aims to identify clinical and imaging prognosticators associated with the successful bridging or downstaging to liver transplantation (lt) in patients undergoing yttrium-90 radio embolization (y90-re) for hepatocellular carcinoma (hcc).The y90 therasphere was referenced in the article.Encephalopathy, ascites, fatigue, abdominal pain, nausea, vomiting, anorexia, constipation, and fever were observed post procedure.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES LTD.; chapman house, farnham bus prk; weydon lane; farnham, surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus prk; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13006697
• MDR Text Key: 282272988
• Report Number: 2134265-2021-15780
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/14/2021
• 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): Other