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 Hemorrhage/Bleeding (1888); Inflammation (1932); Liver Damage/Dysfunction (1954); Renal Failure (2041)

Event Date 09/14/2018

Event Type  Death  

Manufacturer Narrative

Exact date of implant is unknown.Implant date is estimated to the first day of the month of implant.Zhang, j.-w., yu, z.-y., li, h.-b., yi, s.-h., liu, w., yang, y., & wang, g.-y.(2021).Severe bile duct complication after yttrium-90 radioembolization therapy in a patient with recurrent hepatocellular carcinoma after liver transplantation: a case report.Liver research, 5(1), 33,35.Https://doi.Org/10.1016/j.Livres.2020.10.002.

Event Description

It was reported via journal article that a death occurred.Case report: patient with hepatocellular carcinoma (hcc) was treated with therasphere y90 microspheres.Approximately, four weeks post procedure, the patients liver function gradually deteriorated for which he was hospitalized.High body temperature and abdominal distention were also noted.At this time, patient was diagnosed with ischemic-type biliary lesion induced by radioembolization.Patient was treated with liver protection therapy, choleretic therapy, biliary microcirculation improvement treatment, and nutritional support.Symptoms did not improve and renal function declined.Alpha fetoprotein levels increased and computed tomography and magnetic resonance imaging showed worsening of hepatic lesions and ischemic cholangitis.Approximately 12 weeks later, the patient continued to decline and developed a severe upper gastrointestinal hemorrhage and passed away two days later.The cause of death on the death certificate was severe gastrointestinal bleeding cause by liver failure, bile duct injure, liver malignancy recurrence after liver transplantation , lung metastases, and thoracolumbar metastases.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house; farnham bus park; farnham, surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus park; farnham, surrey ; UK
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12061308
• MDR Text Key: 258154392
• Report Number: 2134265-2021-08012
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Death
• Patient Age: 37 YR