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

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

Patient Problems Ulcer (2274); Unintended Radiation Exposure (4565)

Event Date 07/01/2021

Event Type  Injury  

Event Description

It was reported that a gastric ulcer occurred.Y-90 thermosphere was used to treat a patient with advanced stage intrahepatic biliary tract cancer.The microspheres were accidently administered into the gastric arteries, causing a grade 2 - moderate gastric ulcer which was diagnosed by gastroscopy.The patient's hospitalization was prolonged as a result.Four days later, the patient was discharged from the hospital.

Event Description

It was reported that a gastric ulcer occurred.Y-90 therasphere was used to treat a patient with advanced stage intrahepatic biliary tract cancer.The microspheres were accidently administered into the gastric arteries, causing a grade 2 - moderate gastric ulcer which was diagnosed by gastroscopy.The patient's hospitalization was prolonged as a result.Four days later, the patient was discharged from the hospital.It was further reported that the patient had no comorbidities and was in generally good condition.The patient was being treated for cholangiocarcinoma (ccc) and had a child pugh score of a.The patient had had no prior selective internal radiation treatment (sirt) treatments and was administered a lobar dose of 85gy to the left lobe.The gastroscopy was conducted five (5) days post therasphere treatment.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES RADIONUCLIDE
• MDR Report Key: 12204847
• MDR Text Key: 262718613
• Report Number: 2134265-2021-09070
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• 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: 09/27/2021
• 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): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 65