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U.S. Department of Health and Human Services

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

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BIOCOMPATIBLES UK LIMITED 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 Septic Shock (2068); Ulcer (2274)
Event Date 11/08/2021
Event Type  Death  
Manufacturer Narrative
Initial reporter address 1: (b)(6).
 
Event Description
Proactif study. It was reported that duodenal ulceration and death occurred. In (b)(6) 2021, the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day. It was noted that advanced, multicompartment dosimetry was performed to assess the treatment dose. Pre-treatment dosimetry documented a strong uptake of y90 on tumors, dose to perfused liver was 362. 7 gy and dose to perfused tumor was 491. 7 gy. 7. 468 gbq of therasphere was administered to the right liver through vial 1 (ultraselective). The type of therasphere infusion was not documented. Post-treatment dosimetry documented a strong uptake of y90 on tumors, dose to perfused liver was 185 gy and dose to perfused tumor was 371 gy. In (b)(6) 2021, the subject suffered from duodenal ulceration post selective internal radiation therapy (sirt). Hepatectomy was performed. Three days post surgery the subject suffered septic shock. Peritoneal wash was performed. On the same day, the subject passed away.
 
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Brand NameY-90 THERASPHERE (3 GBQ) CANADA COMM
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 Key13023495
MDR Text Key282378223
Report Number2134265-2021-15945
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
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 Received12/02/2021
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: 12/16/2021 Patient Sequence Number: 1
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