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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 Abscess (1690); Respiratory Tract Infection (2420); Ascites (2596); Unspecified Hepatic or Biliary Problem (4493)
Event Date 11/01/2015
Event Type  Injury  
Manufacturer Narrative
Medical assessment from the manufacturer noted that the causality and seriousness assessment of the reported adverse events were not documented in the article. The adverse events of abdominal pain, biliary stricture, weakness, post embolisation syndrome, ascites, increased ast, increased alt. , and increased bilirubin are all anticipated adverse events associated with the use of therasphere. The reported death from pneumocystis pneumonia was assessed by the manufacturer as unrelated to the study device, and administration procedure, as the bacterium pneumocystis carnii is an opportunistic infection agent that develops in patients with acquired immunodeficiency syndrome (aids).
 
Event Description
The article titled, 'combination of 1st and 2nd week dosing of glass yttrium-90 microspheres for superselective radioembolization' by kim et al. , described the results of a single-centre, retrospective review of 53 patients treated with therasphere for hepatocellular carcinoma (hcc). The study compared 32 patients who received of one vial therasphere to 21 patients who received two vials (at the 1st and 2nd week) of therasphere. Adverse events were classified using the ctcae classification system (v5. 0). The article reported 4 cases of grade 3 benign biliary stricture. Grade 3 bile duct stenosis is indicated in ctcae v5. 0 as requiring significant intervention to preclude permanent damage, meeting the criteria of a serious injury. The article also reported a death 9 weeks after radioembolization, though this was related to a pneumocystitis pneumonia infection. The article summarised clinical adverse events in both groups, with the following reported adverse events as grade 3: grade 3: abscess
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1/52; benign biliary stricture
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4/52; ascites
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1/52. Grade 5: pneumocystitis pneumonia
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1/52.
 
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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 Key10908619
MDR Text Key218920929
Report Number3002124543-2020-00022
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
H980006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
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 Received10/27/2020
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: 11/26/2020 Patient Sequence Number: 1
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