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 Problem Inflammation (1932)

Event Type  Injury  

Event Description

A patient was admitted with pneumonitis after treatment with therasphere on the (b)(6)2020.The patient was treated with 2 therasphere vials, with an absorbed dose of 131gy to the target volume.The absorbed dose to the lungs was 10.9gy.The reporting physician was not made aware of the date of admission and was solely informed of the patient's hospitalisation.The date range of the pneumonitis presentation and hospitalisation can range from the day of therasphere treatment (b)(6) to the date the reporter and manufacturer became aware (b)(6).The relationship between the pneumonitis and the therasphere treatment was not stated, but is assumed possibly related as the event occured 9 or less days from therasphere treatment.

Manufacturer Narrative

Medical assessment notes that the patient presented with pneumonitis with an unknown delay after therasphere administration.The whole liver was treated, with an acceptable lung shunt and a small lung dose of 10.8gy.Medical assessment notes that it is unlikely that the pneumonitis is related to radiation treatment with the administered dose.Pneumonitis is listed as a potential adverse event in the therasphere labelling, and is an expected harm associated with therasphere use.

Event Description

A patient was admitted with pneumonitis after treatment with therasphere on the (b)(6) 2020.The patient was treated with 2 therasphere vials, with an absorbed dose of 131gy to the target volume.The absorbed dose to the lungs was 10.9gy.The reporting physician was not made aware of the date of admission and was solely informed of the patient's hospitalisation.The date range of the pneumonitis presentation and hospitalisation can range from the day of therasphere treatment ((b)(6)) to the date the reporter and manufacturer became aware ((b)(6)).The relationship between the pneumonitis and the therasphere treatment was not stated, but is assumed possibly related as the event occured 9 or less days from therasphere treatment.Additional information received on 18-nov-2020: the pneumonitis was resolved at an unknown date, and the patient is doing well.No additional information is available.

Manufacturer Narrative

The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The device remains implanted and will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• 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
• MDR Report Key: 10730924
• MDR Text Key: 213035616
• Report Number: 3002124543-2020-00021
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• Combination Product (y/n): N
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2021

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
• Device Model Number: 990700.SPE
• Device Lot Number: 2099433
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 11/18/2020; 11/18/2020
• Supplement Dates FDA Received: 11/18/2020; 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization