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

Model Number 990700.SPE

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

Patient Problems Pain (1994); Radiation Sickness Syndrome (2256); Liver Failure (4492)

Event Date 10/25/2020

Event Type  Death  

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 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
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK; chapman house; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: sandra bausback-aballo ; 300 four falls corporate cente; 300 conshohocken state road; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 10908797
• MDR Text Key: 218484549
• Report Number: 3002124543-2020-00023
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 990700.SPE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death; Hospitalization