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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  Death  
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, 10/1/2021 implant date - (b)(6) 2009 and (b)(6) 2019. Death date - (b)(6) 2009 and (b)(6). 2019.
 
Event Description
It was reported via abstract article#160: "unresectable intrahepatic cholangiocarcinoma treated with radiation segmentectomy/lobectomy using y90-labeled glass microspheres", patients death occurred. 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). At the time of this analysis, 14 patients had died.
 
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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 Key12814055
MDR Text Key280779163
Report Number2134265-2021-14301
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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