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U.S. Department of Health and Human Services

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

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BIOCOMPATIBLES UK LTD Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Fatigue (1849); Foreign Body Reaction (1868); Hyperbilirubinemia (1903)
Event Date 10/01/2021
Event Type  Injury  
Event Description
It was reported via abstract article#160: "unresectable intrahepatic cholangiocarcinoma treated with radiation segmentectomy/lobectomy using y90-labeled glass microspheres", patients experienced pain, fatigue, toxicity, and hyperbilirubinemia. The purpose of the article is to evaluate the safety and efficacy of radiation segmentectomy/lobectomy using y90-labeled glass microspheres in patients with unresectable intrahepatic cholangiocarcinoma (ihc). This is a single-center, retrospective study included 16 patients with ihc who received radiation segmentectomy or lobectomy treatment using y90-labeled glass microspheres between may 2009 and october 2019. Radiation segmentectomy/lobectomy was defined as at least 190 gy dose delivered into the treated liver volume. Patients were not excluded if they had prior liver-directed therapy or chemotherapy. Median follow-up time was 7. 5 months (range, 2. 4-54. 2 months). Mild, grade 1 or 2 clinical toxicity was reported in 14 patients, the most common complaints were fatigue and abdominal pain. Thirty-three events of mild (grade 1 and 2) biochemical toxicities were detected in 14 patients at 3-month follow-up after treatment. Grade 4 elevated bilirubin was detected in 1 patient.
 
Manufacturer Narrative
Citation: kumar, p. , mhaskar, r. , bibok, a. , kim, r. , anaya, d. , frakes, j. , hoffe, s. , el-haddad, g. , choi, j. , & kis, b. (2021). Abstract no. 160 unresectable intrahepatic cholangiocarcinoma treated with radiation segmentectomy/lobectomy using y90-labeled glass microspheres. Journal of vascular and interventional radiology, 32(5), s71. Https//doi. Org/10. 1016/j. Jvir. 2021. 03. 166. Event date - unknown, use first day month bsc was made aware, (b)(6) 2021. Implant date - (b)(6) 2009 and (b)(6) 2019.
 
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Brand NameY-90 THERASPHERE (3 GBQ) CANADA COMM
Type of DeviceMICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES UK LTD
chapman house farnham bus prk
weydon lane
farnham GU9 8 QL
UK GU9 8QL
Manufacturer (Section G)
BTG INTERNATIONAL CANADA INC.
11 hines road
suite 200 farnham
ottawa, ontario K2K 2 X1
CA K2K 2X1
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12814310
MDR Text Key280822851
Report Number2134265-2021-14260
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,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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: 11/15/2021 Patient Sequence Number: 1
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