MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED 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); Inflammation (1932); Jaundice (2187); Pancreatitis (4481); Unintended Radiation Exposure (4565)

Event Date 08/22/2021

Event Type  Injury  

Event Description

Proactif study.It was reported that pancreatitis occurred.In july 2021, the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.Type of therasphere infusion was in the right anterior sector (segments v/viii).1.03 gbq was administered to the liver (ultra-selective) through vial 1 and 1.06 gbq was administered to the liver (ultra-selective) through vial 2.Total dose administered to the liver was 2.09 gbq.In august 2021, 30 days post index-procedure, the subject was hospitalized for abdominal pain with increased jaundice.The computed tomography (ct) scan was performed for further evaluation; indicated acute pancreatitis.Cholecystitis and radiation or ischemic cholangitis was noted, suspected to be due to embolization of the biliary arteries following radio embolization.The event was treated medically.Subject was made to fast, was hydrated and treated with acupan eps.The liver function was noted to improve spontaneously and subject no longer complained of pain.Six days later, the subject was discharged and the event was considered resolved.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus prk; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• MDR Report Key: 12619084
• MDR Text Key: 276453825
• Report Number: 2134265-2021-12711
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 56