MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED 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); Fatigue (1849); Hyperbilirubinemia (1903); Nausea (1970); Ulcer (2274); Decreased Appetite (4569); Insufficient Information (4580)

Event Date 01/01/2005

Event Type  Injury  

Manufacturer Narrative

Pan, m.M., gabr, a., riaz, a., mouli, s., salem, r., & lewandowski, r.J.(2021).Does significantly elevated lung shunt fraction (lsf >20 percent) promote extrahepatic progression in patients with hepatocellular carcinoma treated with radioembolization? nuclear medicine communications, 42(7), 725,731.Https://doi.Org/10.1097/mnm.0000000000001392.

Event Description

Literature: it was reported that patient complications occurred.A retrospective cohort study was conducted to examine the rate and the pattern of metastasis development, adverse events and overall survival (os) in a patient cohort with hepatocellular carcinoma (hcc) and elevated lung shunt fraction (lsf <20 percent) that underwent y90 radioembolization.Twenty three patients met inclusion criteria and were treated between 2005 and 2016.Many patients experiences intermittent minor fatigue, nausea, anorexia, and abdominal pain.One patient developed a bleeding gastric ulcer requiring hospitalization.No other complications were reported.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• MDR Report Key: 12100146
• MDR Text Key: 259395695
• Report Number: 2134265-2021-08306
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• 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: 06/03/2021
• 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): Required Intervention