MAUDE Adverse Event Report: BWXT 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); Fatigue (1849); Hyperbilirubinemia (1903); Nausea (1970); Stenosis (2263); Decreased Appetite (4569)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

Bibok, andras, et al."role of radioembolization in the management of liver-dominant metastatic renal cell carcinoma: a single-center, retrospective study." cardiovascular and interventional radiology 44.11 (2021): 1755-1762.Date of event was approximated using month of article publication.

Event Description

It was reported via journal article that patient complications occurred.This is a retrospective, single-center study.Thirty-eight patients' medical records were reviewed who underwent tare between january l, 2009, and december 31, 2019, in a tertiary cancer center.Two were excluded from further analysis.Thirty-six patients received 51 tare treatments.The y-90 therasphere was referenced in the study.The 30-day mortality rate was 0%.Mild (ctcae grade 1-2) clinical toxicities were reported by 22 patients: fatigue (n = 17), nausea (n = 5), abdominal pain (n = 4), and decreased appetite (n = 2).Two patients presented with grade 3 biliary strictures 3 and 8 months after tare, which were not related to tumor progression and were attributed to the tare treatment.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BWXT; 447 march road; kanata, on k2k 1x8 ; CA
• 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: 13000803
• MDR Text Key: 282204553
• Report Number: 2134265-2021-15139
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• 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: 11/17/2021
• 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): Other