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

Model Number	990700.SPE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Respiratory Tract Infection (2420); Ascites (2596); Unspecified Hepatic or Biliary Problem (4493)
Date of Event	11/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical assessment from the manufacturer noted that the causality and seriousness assessment of the reported adverse events were not documented in the article.The adverse events of abdominal pain, biliary stricture, weakness, post embolisation syndrome, ascites, increased ast, increased alt., and increased bilirubin are all anticipated adverse events associated with the use of therasphere.The reported death from pneumocystis pneumonia was assessed by the manufacturer as unrelated to the study device, and administration procedure, as the bacterium pneumocystis carnii is an opportunistic infection agent that develops in patients with acquired immunodeficiency syndrome (aids).
Event or Problem Description
The article titled, 'combination of 1st and 2nd week dosing of glass yttrium-90 microspheres for superselective radioembolization' by kim et al., described the results of a single-centre, retrospective review of 53 patients treated with therasphere for hepatocellular carcinoma (hcc).The study compared 32 patients who received of one vial therasphere to 21 patients who received two vials (at the 1st and 2nd week) of therasphere.Adverse events were classified using the ctcae classification system (v5.0).The article reported 4 cases of grade 3 benign biliary stricture.Grade 3 bile duct stenosis is indicated in ctcae v5.0 as requiring significant intervention to preclude permanent damage, meeting the criteria of a serious injury.The article also reported a death 9 weeks after radioembolization, though this was related to a pneumocystitis pneumonia infection.The article summarised clinical adverse events in both groups, with the following reported adverse events as grade 3: grade 3: abscess = 1/52; benign biliary stricture = 4/52; ascites = 1/52.Grade 5: pneumocystitis pneumonia = 1/52.

• Brand Name: THERASPHERE
• Common Device Name: YTTRIUM-90 GLASS MICROSPHERES
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 10908619
• Report Number: 3002124543-2020-00022
• Device Sequence Number: 16948101
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: 990700.SPE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization