MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES

Model Number UNKNOWN

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

Patient Problem Liver Damage/Dysfunction (1954)

Event Type  Injury  

Manufacturer Narrative

The use of therasphere for the treatment of metastatic neuroendocrine tumor (mnet) is considered off-label use.Hepatic decompensation is an anticipated adverse event listed in the product labeling but considered serious and therfore reportable.The two patient deaths reported (at 4.7 years and 3.8 years after the first 90y treatment) and the tumor progression reported in 18 patients is not related to the therasphere treatment.All other device related adverse events reported in the literature are non serious.There was no device failure or malfunction reported, long term morphological liver modification (cirrhosis like imaging) can occur following therasphere treatment, and, consequently, hepatic decompensation and failure could occur.The risk is higher in cases of high tumor load and bilobar treatment.

Event Description

On (b)(6) 2017, the article titled 'long-term hepatotoxicity of yttrium-90 radioembolization as treatment of metastatic neuroendocrine tumor to the liver' authored by the department of radiology at (b)(6) in (b)(6) was reviewed for safety data.The purpose of this study was to determine long-term hepatotoxicity of yttrium-90 (90y) radioembolization in patients treated for metastatic neuroendocrine tumor (mnet) and evaluate if imaging and laboratory findings of cirrhosis-like morphology are associated with clinical symptoms.This is a retrospective review from 2003 to 2016 that was performed for patients with mnet treated with 90y glass microspheres (therasphere).Fifty-four patients were included, with > 2 year follow-up and were stratified into unilobar (n=15) vs whole-liver (n=39) treatment.Preradioembolization imaging and laboratory findings were compared with most recent follow-up for indications of worsening portal hypertension and decline in hepatic function.Among patients who underwent unilobar radioembolization, imaging follow-up at a mean of 4.1 years (range, 2.0-15.2 y) revealed cirrhosis-like morphology in 26.7% (4 of 15), ascites in 13.3% (2 of 15), varices in 6.7% (1 of 15), and a 21.9% increase in splenic volume.The respective incidences in patients treated with whole-liver 90y radioembolization were cirrhosis-like morphology in 56.4% (22 of 39), ascites in 41.0% (16 of 39), varices in 15.4% (6 of 39), and a 64.7% increase in splenic volume.Patients treated with whole-liver radioembolization exhibited significantly decreased platelet counts (p =.023) and lower albumin levels (p =.0002).Eight patients (20.5%) treated with whole-liver radioembolization who exhibited cirrhosis-like morphology showed clinical signs of hepatic decompensation; only 2 of 39 patients (5.1%) had no other causes of hepatotoxicity.A single case of hepatic decompensation in the unilobular treatment arm occurred with a patient that had severe tumor progression.

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: sandra bausback ; 300 barr harbor dr.; five tower bridge - suite 810; west conshohocken,, PA 19428-2998 ; 6103311537
• MDR Report Key: 7142339
• MDR Text Key: 95722813
• Report Number: 3002124543-2017-00054
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other