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 Problem Liver Damage/Dysfunction (1954)

Event Date 10/01/2021

Event Type  Injury  

Event Description

It was reported via the literature article: "safety and efficacy of transarterial radioembolization after prior transarterial chemoembolization" liver dysfunction occurred.Transarterial radioembolization (tare) is a common technique to treat patients with hepatocellular carcinoma refractory to transarterial chemoembolization (tace).Tare can cause liver toxicity.The degree of toxicity may be heightened due to previous liver injury from prior endovascular therapies.This study assessed the safety and changes in liver function after tare for multifocal hepatocellular carcinoma refractory to previous embolization.A retrospective chart review was performed between 2017 and 2019 to identify patients who underwent tace or bland embolization followed by tare for hepatocellular carcinoma.Demographic, laboratory, and imaging information was collected prior to tare and 3, 6, 9, 12, 18, and 24 months after tare.30 patients were included.Mean age was 67.5 years (53-89), 10 were females.There was a median of 2 prior lesion specific treatments for each patient.The mean prescribed y90 activity per was 2.6 gbq.One patient underwent liver transplantation and was found to have >90% necrosis of the hcc on explant pathologic analysis.

Manufacturer Narrative

Apa7 citation: srinivas, s., hsieh, l., rockwell, h., duncan, d., rose, s., minocha, j., & berman, z.(2021).Abstract no.33 safety and efficacy of transarterial radioembolization after prior transarterial chemoembolization.Journal of vascular and interventional radiology, 32(5), s15-s16.Https;//doi.Org/10.1016/j.Jvir.2021.03.449.Date of event: date is unknown, use first of the month bsc was made aware, (b)(6) 2021.Implant date: (b)(6) 2017 and (b)(6) 2019.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus prk; weydon lane; surrey, farnham GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BTG INTERNATIONAL CANADA INC.; 11 hines road; suite 200 farnham; ottawa, ontario K2K 2 X1; CA K2K 2X1
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12813770
• MDR Text Key: 280811331
• Report Number: 2134265-2021-14253
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2021

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: 10/22/2021
• Initial Date FDA Received: 11/15/2021
• 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