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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Foreign Body Reaction (1868); Hyperbilirubinemia (1903)

Event Date 10/01/2021

Event Type  Injury  

Event Description

It was reported via abstract article#160: "unresectable intrahepatic cholangiocarcinoma treated with radiation segmentectomy/lobectomy using y90-labeled glass microspheres", patients experienced pain, fatigue, toxicity, and hyperbilirubinemia. 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). Mild, grade 1 or 2 clinical toxicity was reported in 14 patients, the most common complaints were fatigue and abdominal pain. Thirty-three events of mild (grade 1 and 2) biochemical toxicities were detected in 14 patients at 3-month follow-up after treatment. Grade 4 elevated bilirubin was detected in 1 patient.

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, (b)(6) 2021. Implant date - (b)(6) 2009 and (b)(6) 2019.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES 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 Key: 12814310
• MDR Text Key: 280822851
• Report Number: 2134265-2021-14260
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/15/2021
• 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 Received: 10/22/2021
• 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