MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED Y-90 THERASPHERE (3 GBQ); MICROSPHERES RADIONUCLIDE

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

Patient Problems Hyperbilirubinemia (1903); Unspecified Infection (1930); Stenosis (2263)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Ness j., et al (2021) abstract no.525 yttrium-90 radioembolization of segment iv hepatocellular carcinoma: assessment of biliary complications in a region dense with biliary structures.Journal of vascular and interventional radiology (jvir) 32(5), pp.S140-s141.Date of event was approximated using month of article submission.

Event Description

It was reported via literature article that biliary complications occurred, which included: biloma, cholecystitis, biliary strictures, and hyperbilirubinemia.A single-institution retrospective analysis of patients with segment iv hepatocellular carcinoma (hcc) treated with yttrium-90 microspheres from 2013 to 2019 was performed.Inclusion criteria included: diagnosis of hcc to segment iv, at least one follow-up computed tomography or magnetic resonance examination within 90 days of treatment, and serum total bilirubin before and within 90 days post treatment.Exclusion criteria included liver transplantation.Thirty patients met criteria with an average length of follow-up imaging at 46 days.Biliary complications included, but were not limited to: biloma, cholecystitis, biliary strictures, and grade 3 or 4 biliary toxicity by national cancer institute criteria.Of 30 patients, one patient was found to have multifocal biliary strictures requiring two biliary stents on endoscopic retrograde cholangiopancreatography five months post procedure.Two patients demonstrated grade 3/4 bilirubin toxicity.The average treatment dosage was 135 gray with a range of 95 to 341 gray.Compared to the biliary complication rate described in the literature for hcc with 2.1% for biliary findings on imaging and 6.8% for grade 3/4 bilirubin toxicity, this study showed comparable rates of 3.3% and 6.7%, respectively.Yttrium-90 radioembolization of segment iv hcc demonstrated no significant difference in biliary complication rates compared to nonsegment specific biliary complication rates reported in the literature.

• Brand Name: Y-90 THERASPHERE (3 GBQ)
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus prk; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus prk; 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: 12804802
• MDR Text Key: 280703315
• Report Number: 2134265-2021-14264
• 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: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2021

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
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/12/2021
• 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