MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW, PRODUCT

Model Number 2.2 GBQ

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

Patient Problem Abdominal Pain (1685)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

Company medical assessment comments: the reported adverse events are known inherent risks associated with sirt listed in the ifu/risk management documentation.No device malfunction was reported or identified.No batch review was possible for this case as the batch number has not been provided and the product was not returned for evaluation (device remains implanted in the patient).No corrective/preventative action has been identified.Should we receive any information to enable further investigations, a follow-up report will be submitted.At this time this report is considered final.

Event Description

Auto-notification received from datatrak for subject enrolled on (b)(6) study: unique patient id: (b)(6); (b)(6) year old, male patient, weight: (b)(6).Diagnosed with hcc: (b)(6) 2020 etiology of underlying liver disease: alcohol, (b)(6).Multifocal 5-10 lesions; right liver (segments v-vi-vii-viii) and section i presence of pvt - cruoric no prior anti-cancer treatment.Pre-treatment biology ecog: 0.Bclc: c.Ascites and child pugh not documented.Therasphere treatment: (b)(6) 2020 via femoral artery.Total dose administered 2.2 gbq.Volume of total perfused liver normal tissue (cm^3): 638.Patient presented with abdominal pain and was urgently admitted to hospital (b)(6) 2020.The hospitalised real ct scan did not show mesenteric ischemia, secondary tumour necrosis and extension of the portal thrombosis of the right hepatic vein.Stable biology with cytolysis radiologist advice: monitoring for 48 hours.Medical intervention: analgesic pain associated with secondary tumor necrosis and extension of the portal thrombosis of the right hepatic vein discharged on (b)(6) 2020.

Event Description

This mdr documents the medical assessment of the reported adverse event of abdominal pain.Further follow-up is not anticipated for this event.

Manufacturer Narrative

The medical assessment concurred that the abdominal pain as related to the device, noting that the adverse event occurred three days post-procedure.Information gathered within the clinical trial electronic data capture (edc) determined that the patient received therasphere on (b)(6) 2020.The volume of total perfused liver was 915cm3, and volume of total perfused liver normal tissue was 630cm3.The pre-treatment and post-treatment volume, absorbed dose to perfused dosimetry was concordant, with strong uptake of both 99tc-maa and y90 observed in both pre-treatment and post-treatment imaging, respectively.Pre-treatment maa dosimetry: the planned dose to the perfused liver was 120gy, with an estimated 179gy to the perfused tumour.Post-treatment dosimetry: the delivered dose to the perfused liver was 120gy, and 213gy delivered to the perfused tumour.

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW, PRODUCT
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 10187811
• MDR Text Key: 202860640
• Report Number: 3002124543-2020-00017
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2.2 GBQ
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 60