MAUDE Adverse Event Report: BIOCOMPATIBLES LTD. Y-90 THERASPHERE (3 GBQ) CANADA COMM; MICROSPHERES RADIONUCLIDE

Model Number 2361-01

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

Patient Problems Diarrhea (1811); Fatigue (1849); Hyperbilirubinemia (1903); High Blood Pressure/ Hypertension (1908); Nausea (1970); Vomiting (2144); Thrombocytopenia (4431)

Event Date 09/09/2021

Event Type  Injury  

Event Description

It was reported via journal article that patient complications occurred.A retrospective single center study was performed with 38 child-pugh a patients with advanced/metastatic hcc.In sum, 34 received sorafenib, followed after 4 weeks by 90y gms.Analysis of safety and survival outcomes was performed to assess adverse events, median progression-free survival, and overall survival.The y-90 therasphere dose vials were referenced within the study.Grade iii-iv adverse events from the combination of sorafenib and therasphere comprised fatigue, diarrhea, nausea, vomiting, hypertension, thrombocytopenia, hyperbilirubinemia, proteinuria, hyponatremia, and elevated alanine or aspartate aminotransferase.

Manufacturer Narrative

Journal article: kaseb, ahmed omar, et al."a prospective phase ii study of safety and efficacy of sorafenib followed by 90y glass microspheres for patients with advanced or metastatic hepatocellular carcinoma." journal of hepatocellular carcinoma 8 (2021): 1129.Date of event = month of article submission.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES LTD.; chapman house, farnham bus prk; weydon lane; farnham, surrey ; UK
• 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: 12994106
• MDR Text Key: 282192023
• Report Number: 2134265-2021-15137
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2361-01
• Device Catalogue Number: 2361-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• 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): Other