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 Fever (1858); Jaundice (2187); Ascites (2596); Liver Failure (4492); Swelling/ Edema (4577)

Event Date 12/05/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

Proactif study.It was reported that death occurred.In (b)(6) 2020, the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.Advanced, multicompartment dosimetry was performed to assess treatment dose.Pre-treatment dosimetry documented a strong uptake of y90 on tumors, dose to perfused liver was 78 gy and dose to perfused tumor was 372 gy.The type of therasphere infusion was in right hepatic artery (irrespective of origin) (segments v/vi/vii/viii).1.54 gbq of therasphere was administered to the right liver through vial 1.On (b)(6) 2020, the subject was hospitalized due to mild ascites with moderate lower limb edema.Jaundice with fever was noted and hepatic failure increased.The subject was treated with antibiotherapy and started on tazocilline iv.On (b)(6) 2021, 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; 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: 13024312
• MDR Text Key: 282379712
• Report Number: 2134265-2021-15946
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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: 12/05/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 32 KG