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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 Problem Liver Damage/Dysfunction (1954)
Event Date 10/01/2021
Event Type  Injury  
Event Description
It was reported via the literature article: "safety and efficacy of transarterial radioembolization after prior transarterial chemoembolization" liver dysfunction occurred. Transarterial radioembolization (tare) is a common technique to treat patients with hepatocellular carcinoma refractory to transarterial chemoembolization (tace). Tare can cause liver toxicity. The degree of toxicity may be heightened due to previous liver injury from prior endovascular therapies. This study assessed the safety and changes in liver function after tare for multifocal hepatocellular carcinoma refractory to previous embolization. A retrospective chart review was performed between 2017 and 2019 to identify patients who underwent tace or bland embolization followed by tare for hepatocellular carcinoma. Demographic, laboratory, and imaging information was collected prior to tare and 3, 6, 9, 12, 18, and 24 months after tare. 30 patients were included. Mean age was 67. 5 years (53-89), 10 were females. There was a median of 2 prior lesion specific treatments for each patient. The mean prescribed y90 activity per was 2. 6 gbq. One patient underwent liver transplantation and was found to have >90% necrosis of the hcc on explant pathologic analysis.
 
Manufacturer Narrative
Apa7 citation: srinivas, s. , hsieh, l. , rockwell, h. , duncan, d. , rose, s. , minocha, j. , & berman, z. (2021). Abstract no. 33 safety and efficacy of transarterial radioembolization after prior transarterial chemoembolization. Journal of vascular and interventional radiology, 32(5), s15-s16. Https;//doi. Org/10. 1016/j. Jvir. 2021. 03. 449. Date of event: date is unknown, use first of the month bsc was made aware, (b)(6) 2021. Implant date: (b)(6) 2017 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 LIMITED
chapman house farnham bus prk
weydon lane
surrey, 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 Key12813770
MDR Text Key280811331
Report Number2134265-2021-14253
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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