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U.S. Department of Health and Human Services

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

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BIOCOMPATIBLES 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); Diarrhea (1811)
Event Date 11/01/2020
Event Type  Injury  
Event Description
It was reported via journal article that patient complications occurred. A single center retrospective review of patients who underwent lobar tare prior to major hepatectomy for primary or metastatic liver cancer between 2007 and 2018 was conducted. The y-90 therasphere was referenced in the article. Grade iii diarrhea and grade iii abdominal pain after tare were reported.
 
Manufacturer Narrative
Journal article: ahmed a, stauffer ja, legout jd, burns j, croome k, paz-fumagalli r, frey g, toskich b. The use of neoadjuvant lobar radioembolization prior to major hepatic resection for malignancy results in a low rate of post hepatectomy liver failure. J gastrointest oncol 2021;12(2): 7 51- 761. Doi: 10. 21037/jgo-20-507. Date of event: the date of event is not specified therefore the date of the article submission was used.
 
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Brand NameY-90 THERASPHERE (3 GBQ) CANADA COMM
Type of DeviceMICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES LTD.
chapman house, farnham bus prk
weydon lane
farnham, surrey
UK
Manufacturer (Section G)
BIOCOMPATIBLES LTD.
chapman house, farnham bus prk
farnham, surrey
UK
Manufacturer Contact
johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13006552
MDR Text Key282273174
Report Number2134265-2021-15764
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 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
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 Received11/17/2021
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: 12/14/2021 Patient Sequence Number: 1
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