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

Model Number 3.78GBQ

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

Patient Problems Fever (1858); Liver Damage/Dysfunction (1954); Ascites (2596)

Event Date 05/08/2020

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 i considered final.

Event Description

Autonotification received from (b)(6) 26-may-2020 as follows: site number : (b)(6), unique patient id : (b)(6), diagnostic term to describe primary sae: ascitis, seriousness criteria (saecrit): led to a serious deterioration in health, start date: (b)(6) 2020, severity (ctcae v5.0 grade): grade 2, causality related to administration procedure: not related, causality related to therasphere device: definitely.(b)(6) male patient.Obese patient with a bmi of 35.4, (b)(6) kg.Diagnoses with hcc (b)(6) 2020, etiology of underlying liver disease: alcohol, dysmetabolic.Tumour characteristics: multifocal, 2-4 lesions 4 mm diameter index lesion in, right liver segment viii, presence of pvt (tumoural), tumor burden 10%, no ehd.No prior anti-cancer treatments received.Main comorbidities: hyperglycemia, diabetes, coronary arterial disease, alcohol intake history, tobacco intake history, renal disease.Therasphere treatment - (b)(6) 2020 3.78 gbq administered to right liver via femoral artery.It was noted: significantly higher overall perfusion in tumour versus normal liver.Complete distribution (y90 distribution in 99-100% the all/near all the tumour volume).Event: on the (b)(6) 2020 the patient was admitted to the hospital for the occurrence of ascites, oedema, worsening of renal function, and hypoxemia, child b9.Action taken: concomitant medication.Oxygen, ascites removal.Discharged: (b)(6) 2020.Intervention: evacuation of the peritoneal fluid.

• 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
• Manufacturer (Section G): BIOCOMPATIBLES UK; chapman house; weydon lane; farnham, surrey ; UK
• Manufacturer Contact: sandra bausback-aballo ; 300 four falls corporate cntr; 300 conshohocken state road; west conshohocken, pa ; 3311537
• MDR Report Key: 10187867
• MDR Text Key: 201166581
• Report Number: 3002124543-2020-00016
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2020

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: 3.78GBQ
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 106