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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 Pain (1994); Radiation Sickness Syndrome (2256); Liver Failure (4492)
Event Date 10/25/2020
Event Type  Death  
Manufacturer Narrative
Medical assessment from the manufacturer noted that all patients presenting with grade 3 adverse events received sequential bilobar treatment, and commented on the infrequent rate of reported grade 3 adverse events (3 out of 32 patients). Reild, pain and worsening liver function are all anticipated adverse events associated with the use of therasphere. The medical assessment concurred with the reporter's assessment of the radioembolization-induced liver disease (reild) that resulted in the patients death. The medical assessment noted that the event was likely caused from a combination of receiving therasphere to the whole liver, along with any chemotherapy the patient had received prior to therasphere treatment.
 
Event Description
The meeting abstract titled: "yttrium-90 glass microsphere transarterial radioembolization for patients with unresectable liver-dominant breast cancer metastasis " by rishi et al. Described the results of a single-centre, retrospective review of 32 breast cancer patients treated with therasphere for liver-metastases. Adverse events were classified using the ctcae classification system (v5. 0). The article reported pain (2 patients) and worsening liver-function (1 patient). One additional patient died from radioembolization-induced liver disease within 30 days of therasphere treatment.
 
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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 Key10908797
MDR Text Key218484549
Report Number3002124543-2020-00023
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H980006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
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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