MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ONCOZENE MICROSPHERES; EMBOLIC DEVICE

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

Patient Problems Encephalopathy (1833); Pleural Effusion (2010); Ascites (2596); Liver Failure (4492); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/11/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).Wholey, michael, et al."safety and long-term survival outcome in patients with unresectable barcelona clinic liver cancer (bclc) stages c and d advanced hepatocellular carcinoma treated with 40 drug-eluting bead transcatheter arterial chemoembolization." cureus 14.4 (2022).

Event Description

It was reported via a journal article that patient complications occurred.Background: to evaluate the safety, treatment response, and overall survival (os) following drug-eluting bead transarterial chemoembolization (deb-tace) using doxorubicin-loaded microspheres in patients with advanced hepatocellular carcinoma (hcc).Methods: this was a single-center retrospective evaluation of patients with unresectable hcc without extrahepatic spread and barcelona clinic liver cancer (bclc) stages c and d disease who underwent deb-tace between august 2015 and january 2018.Pre-treatment data included demographics, medical history, cancer staging, tumor size, laboratory results, and prior treatments for hcc.Follow-up data included the date of deb-tace treatments or microwave ablation (mwa) procedures, laboratory test results, adverse events, treatment response, and the date and cause of death.Results: thirty-two patients met the study inclusion criteria.Eighteen patients (56.3%) underwent a single debtace and 14 patients (43.8%) had two to five deb-tace procedures.Five patients (15.6%) had mwa following initial deb-tace.Mild postembolization syndrome occurred in six patients (18.8%) during a 30- day period following initial deb-tace.Seven patients (21.9%) experienced worsening ascites, pleural fluid, or encephalopathy during the study observation period.Three patients had moderate to severe worsening liver function tests 90 days post-procedure.Seventeen patients (53.1%) had a complete or partial response and nine patients (28.1%) had disease progression.Median os was 15.0 -14.4 months from the time of initial deb-tace, with 63% and 33% of patients still alive at 12 and 24 months.Multivariate analyses identified that okuda stage (p=0.03) and cancer of the liver italian programme (clip) score (p=0.05) were significantly associated with overall survival after adjusting for other covariates.There were four hcc related deaths during the 30-day post-procedure period.

• Brand Name: ONCOZENE MICROSPHERES
• Type of Device: EMBOLIC DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15126014
• MDR Text Key: 296845786
• Report Number: 2134265-2022-08230
• Device Sequence Number: 1
• Product Code: KRD
• 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: Physician
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: 07/01/2022
• 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