MAUDE Adverse Event Report: CHAPMAN HOUSE, FARNHAM BUS PARK 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 01/01/2004

Event Type  Injury  

Manufacturer Narrative

Gabr, ahmed, et.Al, liver transplantation following yttrium-90 radioembolization: 15 year experience in 207 patient cohort, hepatology, 2021, vol.73, no.3, pg.998-1010.Date of event: the article states that patient treatments occurred from 2004 to 2018.

Event Description

It was reported via literature article that toxicities occurred.A 207 patient cohort of patients undergoing liver transplant following y90 treatment between 2004 and 2018 were followed.Seven patients exhibited grade 3 albumin toxicities; all but 1 was pre-existing before y90.Twenty-seven patients exhibited grade 3 bilirubin toxicities; all but 9 were pre-existing before y90.In conclusion: y90 is an effective treatment for hcc in the setting of bridging/downstaging to liver transplantation.Patients who achieved extensive or complete necrosis had better recurrence-free survival, supporting the practice of neoadjuvant treatment before liver transplant.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): CHAPMAN HOUSE, FARNHAM BUS PARK; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• MDR Report Key: 12059432
• MDR Text Key: 258141861
• Report Number: 2134265-2021-07859
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 06/24/2021

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: 06/03/2021
• Initial Date FDA Received: 06/24/2021
• 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