MAUDE Adverse Event Report: BIOCOMPATIBLES LTD. 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); Diarrhea (1811)

Event Date 11/01/2020

Event Type  Injury  

Event Description

It was reported via journal article that patient complications occurred.A single center retrospective review of patients who underwent lobar tare prior to major hepatectomy for primary or metastatic liver cancer between 2007 and 2018 was conducted.The y-90 therasphere was referenced in the article.Grade iii diarrhea and grade iii abdominal pain after tare were reported.

Manufacturer Narrative

Journal article: ahmed a, stauffer ja, legout jd, burns j, croome k, paz-fumagalli r, frey g, toskich b.The use of neoadjuvant lobar radioembolization prior to major hepatic resection for malignancy results in a low rate of post hepatectomy liver failure.J gastrointest oncol 2021;12(2): 7 51- 761.Doi: 10.21037/jgo-20-507.Date of event: the date of event is not specified therefore the date of the article submission was used.

• 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 LTD.; chapman house, farnham bus prk; farnham, surrey; UK
• Manufacturer Contact: johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13006552
• MDR Text Key: 282273174
• Report Number: 2134265-2021-15764
• 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: 12/14/2021

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
• 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