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U.S. Department of Health and Human Services

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

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BIOCOMPATIBLES UK LTD THERASPHERE YTTRIUM-90 GLASS MICROSPHERES 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); Ascites (2596); Swelling/ Edema (4577)
Event Date 08/24/2020
Event Type  Death  
Manufacturer Narrative
Medical assessment from the manufacturer concurred with the reported causal relationship between the device, and the adverse event. Ascites, edema, and hepatic decompensation are listed as potential adverse events within the ifu. The tumours and portal vein thrombosis exhibited strong 99tc-maa during the pre-treatment work-up. Post treatment dosimetry was not performed by the treating physician. The clinical deterioration of the patient's condition was documented by grade 2 hyperbilirubinemia and grade 3 ascites. The patient required paracentesis and diuretic treatment.
 
Event Description
Patient: (b)(6), with an infiltrative hcc tumour in the right and left liver, was enrolled in the (b)(6) on (b)(6) 2020. The patient was treated using a selective approach with 2 vials. The delivered dose to the perfused, and whole liver is currently undetermined. On (b)(6) 2020, the subject developed edematous ascites decompensation, assessed as grade 3 according to the ctcae v5. 0. The resolution of the adverse event is currently unknown. The adverse event was assessed by the physician as definitely related to the procedure. The event was initially reported as an adverse event, but not a serious adverse event, but required a surgical procedure, and concomitant medication to resolve.
 
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Brand NameTHERASPHERE
Type of DeviceYTTRIUM-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 Key10659504
MDR Text Key214754953
Report Number3002124543-2020-00019
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,Followup,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number990700.SPE
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 Received10/21/2020
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: 10/09/2020 Patient Sequence Number: 1
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