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); Dyspnea (1816); Encephalopathy (1833); Fatigue (1849); Hematoma (1884); Liver Damage/Dysfunction (1954); Nausea (1970); Renal Failure (2041); Sepsis (2067); Ascites (2596); Liver Failure (4492); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2007

Event Type  Death  

Manufacturer Narrative

Gordon, andrew, et.Al., safety and efficacy of segmental yttrium-90 radioembolization of hepatocellular carcinoma after transjugular intrahepatic portosystemic shunt creation, j vasc interv radiol 2021; 32:211-219.Date of event: patient treatments occurred from (b)(6) 2007 to (b)(6) 2017.

Event Description

It was reported via literature article that adverse events occurred.A single-arm retrospective study included 39 patients (16 women, 23 men) with ages 49-81 years old who were treated with y90 between august 2007 and october 2017.The most common mild grade 1/2 clinical toxicities were fatigue (51.3%), abdominal pain (12.8%), and nausea (10.3%).The incidence of any significant grade 3 clinical toxicity was 5.1% (n 1/4 2).There were no grade 4 clinical toxicities.One patient with child-pugh c disease and a meld score of 22 at baseline presented with encephalopathy, jaundice, and ascites, with development of tumor progression, liver failure, renal failure, and sepsis with multiorgan failure and death after 34 days.A second patient experienced grade 3 abdominal pain and dyspnea requiring admission for volume overload 27 days after y90 radioembolization.Vascular complications included groin hematoma and ecchymosis (n 1/4 1) requiring evaluation; the patient was uneventfully discharged after a site check in the emergency department.In conclusion, segmental y90 is safe and has high antitumor activity after transjugular intrahepatic portosystemic shunt (tips) placement.Preserved transplant eligibility suggests that y90 is a useful tool to bridge patients to liver transplantation in select patients with hepatocellular carcinoma (hcc) with existing tips.

• 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; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12049658
• MDR Text Key: 257743702
• Report Number: 2134265-2021-07863
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• 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