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U.S. Department of Health and Human Services

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

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BIOCOMPATIBLES UK LTD THERASPHERE YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW Back to Search Results
Model Number 990700.SPE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Liver Damage/Dysfunction (1954); Pleural Effusion (2010); Jaundice (2187); Radiation Sickness Syndrome (2256); Ascites (2596)
Event Date 05/27/2019
Event Type  Death  
Manufacturer Narrative
Btg medical assessment: the investigator, named the event as reild, radio embolisation induced liver disease, that is a life-threatening liver damage characterised by jaundice and ascites developing 4-8 weeks after treatment, with pathologic changes consistent with vod in the most severe cases. In the edc (electronic data capture) did not document the biology and clinical data (ascites, encephalopathy, child score, bclc). Adverse event assessment: reild (radiation induced liver disease) severity: grade 4; serious event - lead to death; anticipated events; related to device. No device malfunction was reported and no corrective and preventive action (capa) plan has been unidentified. The lot number associated with the therasphere administration was not reported, therefore no investigation could be performed. If additional information becomes available, a follow up report will be submitted. No other information is available that could confirm/deny the alleged event. At this time this report is considered final.
 
Event Description
Auto-notification received from datatrak 12-mar-2020 for a patient enrolled on the (b)(6)study pt: (b)(6) is a (b)(6) old male patient. Weight: (b)(6) kg. Main comorbidities: arterial hypertension; alcohol intake history; tobacco intake history. Diagnosed with hcc (b)(6) 2016. 2-4 lesions - right and left segments. Location of index lesion
=
vi. Pvt present - yes (tumoural) no extra hepatic disease. Prior anti-cancer therapy: loco regional liver treatment(s)
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2. Ablation: rfa, microwave or cryo. Event: on (b)(6) 2019, patient was administered 3. 225 gbq of therasphere in the right liver. On (b)(6) 2019, patient was admitted to the hospital with hepatitis decompensation with ascites and jaundice at 1-month post-radio-embolisation. Further, ascites and pleural effusion apparition with repeated paracentesis has been reported. On (b)(6) 2019, radio-induced liver disease was reported. Seriousness criteria - led to a death on (b)(6) 2019. The investigator has listed the causality probably related to the administration procedure and to the device. Sae assessed by investigator: related to administration procedure: probably. Related to therasphere device: probably. This event is part of a clinical trial registry and was not reported to btg in 2019 the reported events are known adverse events listed in the ifu/risk management documentation.
 
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Brand NameTHERASPHERE
Type of DeviceYTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW
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 Key9932767
MDR Text Key187044044
Report Number3002124543-2020-00007
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
H980006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number990700.SPE
Device Catalogue NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2020
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 Treatment Data
Date Received: 04/07/2020 Patient Sequence Number: 1
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