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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (10 GBQ) CN CLINICAL; MICROSPHERES RADIONUCLIDE
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BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (10 GBQ) CN CLINICAL; MICROSPHERES RADIONUCLIDE Back to Search Results
Model Number 2361-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Liver Damage/Dysfunction (1954); Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/12/2023
Event Type  Injury  
Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: the subject was 69 years old at the time of study enrollment.D3 & g1 - manufacturer address 1: chapman house, farnham bus park.D3 & g1 - manufacturer zip/postal code: gu9 8ql.H6 - patient codes: e2402 used to describe reported event of post-interventional embolization syndrome.
 
Event Description
It was reported that the subject experienced elevated glutamyl transpeptidase, interventional embolization syndrome, and a urinary tract infection following the index procedure.On (b)(6) 2023, the subject was randomized (therasphere arm) in the mandarin study (main phase).Planned treatment type was uni-lobar treatment.Treatment with therasphere was performed on (b)(6) 2023.99mtc-maa angiogram was performed and target volume was 66.46 cm3.10 gbq was administered through one vial.On 12-sep-2023, 28 days post index procedure, lab results revealed elevated glutamyl transpeptidase (ggt).Nci-ctcae v5.0 grade- 1 (mild).Information regarding the corrective action taken to treat the event is currently unavailable.At the time of reporting, outcome of the event was considered not resolved.On (b)(6) 2023, 34 days post index procedure, subject was diagnosed to have post-interventional embolization syndrome.Nci-ctcae v5.0 grade- 1 (mild).Metoclopramide hydrochloride injection was given.On (b)(6) 2023, the event was considered resolved.On (b)(6) 2023, 35 days post index procedure, subject was diagnosed to have urinary tract infection.Nci-ctcae v5.0 grade- 2 (moderate).Levofloxacin tablets were given as a corrective action to treat the event.On (b)(6) 2023, the event was considered resolved.
 
Event Description
Mandarin.It was reported that the subject experienced elevated glutamyl transpeptidase, interventional embolization syndrome, and a urinary tract infection following the index procedure.On (b)(6) 2023, the subject was randomized (therasphere arm) in the mandarin study (main phase).Planned treatment type was uni-lobar treatment.Treatment with therasphere was performed on (b)(6) 2023.99mtc-maa angiogram was performed and target volume was 66.46 cm3.10 gbq was administered through one vial.On (b)(6) 2023, 28 days post index procedure, lab results revealed elevated glutamyl transpeptidase (ggt).Nci-ctcae v5.0 grade- 1 (mild).Information regarding the corrective action taken to treat the event is currently unavailable.At the time of reporting, outcome of the event was considered not resolved.On (b)(6) 2023, 34 days post index procedure, subject was diagnosed to have post-interventional embolization syndrome.Nci-ctcae v5.0 grade- 1 (mild).Metoclopramide hydrochloride injection was given.On (b)(6) 2023, the event was considered resolved.On (b)(6) 2023, 35 days post index procedure, subject was diagnosed to have urinary tract infection.Nci-ctcae v5.0 grade- 2 (moderate).Levofloxacin tablets were given as a corrective action to treat the event.On (b)(6) 2023, the event was considered resolved.It was further reported that the previously reported events of post-interventional embolization syndrome and urinary tract infection are no longer alleged as having been the result of the therasphere device or the index procedure.
 
Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: the subject was 69 years old at the time of study enrollment.D3 & g1 - manufacturer address 1: chapman house, farnham bus park; d3 & g1 - manufacturer zip/postal code: gu9 8ql.
 
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Brand Name
THERASPHERE Y-90 (10 GBQ) CN CLINICAL
Type of Device
MICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES UK LIMITED
weydon lane, farnham
surrey
UK 
Manufacturer (Section G)
BIOCOMPATIBLES UK LIMITED
weydon lane, farnham
surrey
UK  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18292004
MDR Text Key330054542
Report Number2124215-2023-68509
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number2361-01
Device Catalogue Number2361-01
Device Lot Number2399370
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
Patient Weight64 KG
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