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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  Death  

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, 10/1/2021 implant date - (b)(6) 2009 and (b)(6) 2019.Death date - (b)(6) 2009 and (b)(6).2019.

Event Description

It was reported via abstract article#160: "unresectable intrahepatic cholangiocarcinoma treated with radiation segmentectomy/lobectomy using y90-labeled glass microspheres", patients death occurred.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).At the time of this analysis, 14 patients had died.

• 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: 12814055
• MDR Text Key: 280779163
• Report Number: 2134265-2021-14301
• 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: Physician
• 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: Health Professional
• 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 Sequence Number: 1
• Patient Outcome(s): Death