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	Pain (1994); Radiation Sickness Syndrome (2256); Liver Failure (4492)
Date of Event	10/25/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Medical assessment from the manufacturer noted that all patients presenting with grade 3 adverse events received sequential bilobar treatment, and commented on the infrequent rate of reported grade 3 adverse events (3 out of 32 patients).Reild, pain and worsening liver function are all anticipated adverse events associated with the use of therasphere.The medical assessment concurred with the reporter's assessment of the radioembolization-induced liver disease (reild) that resulted in the patients death.The medical assessment noted that the event was likely caused from a combination of receiving therasphere to the whole liver, along with any chemotherapy the patient had received prior to therasphere treatment.
Event or Problem Description
The meeting abstract titled: "yttrium-90 glass microsphere transarterial radioembolization for patients with unresectable liver-dominant breast cancer metastasis " by rishi et al.Described the results of a single-centre, retrospective review of 32 breast cancer patients treated with therasphere for liver-metastases.Adverse events were classified using the ctcae classification system (v5.0).The article reported pain (2 patients) and worsening liver-function (1 patient).One additional patient died from radioembolization-induced liver disease within 30 days of therasphere treatment.

• 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: 10908797
• Report Number: 3002124543-2020-00023
• Device Sequence Number: 14257195
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: health professional,literatur
• 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