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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED Y-90 THERASPHERE (3 GBQ) MICROSPHERES RADIONUCLIDE

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BIOCOMPATIBLES UK LIMITED Y-90 THERASPHERE (3 GBQ) MICROSPHERES RADIONUCLIDE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperbilirubinemia (1903); Unspecified Infection (1930); Stenosis (2263)
Event Date 05/01/2021
Event Type  Injury  
Manufacturer Narrative
Ness j. , et al (2021) abstract no. 525 yttrium-90 radioembolization of segment iv hepatocellular carcinoma: assessment of biliary complications in a region dense with biliary structures. Journal of vascular and interventional radiology (jvir) 32(5), pp. S140-s141. Date of event was approximated using month of article submission.
 
Event Description
It was reported via literature article that biliary complications occurred, which included: biloma, cholecystitis, biliary strictures, and hyperbilirubinemia. A single-institution retrospective analysis of patients with segment iv hepatocellular carcinoma (hcc) treated with yttrium-90 microspheres from 2013 to 2019 was performed. Inclusion criteria included: diagnosis of hcc to segment iv, at least one follow-up computed tomography or magnetic resonance examination within 90 days of treatment, and serum total bilirubin before and within 90 days post treatment. Exclusion criteria included liver transplantation. Thirty patients met criteria with an average length of follow-up imaging at 46 days. Biliary complications included, but were not limited to: biloma, cholecystitis, biliary strictures, and grade 3 or 4 biliary toxicity by national cancer institute criteria. Of 30 patients, one patient was found to have multifocal biliary strictures requiring two biliary stents on endoscopic retrograde cholangiopancreatography five months post procedure. Two patients demonstrated grade 3/4 bilirubin toxicity. The average treatment dosage was 135 gray with a range of 95 to 341 gray. Compared to the biliary complication rate described in the literature for hcc with 2. 1% for biliary findings on imaging and 6. 8% for grade 3/4 bilirubin toxicity, this study showed comparable rates of 3. 3% and 6. 7%, respectively. Yttrium-90 radioembolization of segment iv hcc demonstrated no significant difference in biliary complication rates compared to nonsegment specific biliary complication rates reported in the literature.
 
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Brand NameY-90 THERASPHERE (3 GBQ)
Type of DeviceMICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES UK LIMITED
chapman house farnham bus prk
weydon lane
farnham, surrey GU9 8 QL
UK GU9 8QL
Manufacturer (Section G)
BIOCOMPATIBLES UK LIMITED
chapman house farnham bus prk
weydon lane
farnham, surrey GU9 8 QL
UK GU9 8QL
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12804802
MDR Text Key280703315
Report Number2134265-2021-14264
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received10/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/12/2021 Patient Sequence Number: 1
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