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 Septic Shock (2068); Ulcer (2274)

Event Date 11/08/2021

Event Type  Death  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

Proactif study.It was reported that duodenal ulceration and death occurred.In (b)(6) 2021, the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.It was noted that advanced, multicompartment dosimetry was performed to assess the treatment dose.Pre-treatment dosimetry documented a strong uptake of y90 on tumors, dose to perfused liver was 362.7 gy and dose to perfused tumor was 491.7 gy.7.468 gbq of therasphere was administered to the right liver through vial 1 (ultraselective).The type of therasphere infusion was not documented.Post-treatment dosimetry documented a strong uptake of y90 on tumors, dose to perfused liver was 185 gy and dose to perfused tumor was 371 gy.In (b)(6) 2021, the subject suffered from duodenal ulceration post selective internal radiation therapy (sirt).Hepatectomy was performed.Three days post surgery the subject suffered septic shock.Peritoneal wash was performed.On the same day, the subject passed away.

• 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
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus prk; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13023495
• MDR Text Key: 282378223
• Report Number: 2134265-2021-15945
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• 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: 12/02/2021
• 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
• Patient Age: 80 YR
• Patient Sex: Male