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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); Inflammation (1932)
Event Date 07/01/2021
Event Type  Injury  
Manufacturer Narrative
Journal article: https://doi. Org/10. 1016/j. Jvir. 2021. 07. 016. Date of event: the date of event is not specified therefore the date of the article submission was used.
 
Event Description
It was reported via journal article radiation colitis occurred. The article reviewed evidence to support the delivery of yttrium-90 (90y) at higher doses (>190 gy) selectively to the hepatic segments, termed radiation segmentectomy, for both primary hepatocellular carcinoma and metastatic disease. Radioembolization with 1. 733 gbq of therasphere glass microspheres was administered to the segment 6 artery supplying 150 ml of liver volume with a resultant dose of 551. 7 gy. The segment 5 artery was also catheterized, and 1. 834 gbq of glass microspheres were administered to 70 ml of liver volume with a resultant dose of 1251 gy. The patient experienced radiation colitis following segment 6 radiation segmentectomy with a >500 gy dose, resulting in a prolonged course of right sided abdominal pain and focal thickening of the colonic wall abutting the treated segment 6.
 
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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 UK LIMITED
chapman house farnham bus prk
weydon lane
farnham, surrey
UK
Manufacturer Contact
johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13006689
MDR Text Key282335686
Report Number2134265-2021-15753
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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