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

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

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hemorrhage/Bleeding (1888); Nausea (1970)

Event Date 07/17/2020

Event Type  Death  

Manufacturer Narrative

Date of event: event date not provided and publication date of journal article was used.Sebastian, nikhil t., et al."a pilot trial evaluating stereotactic body radiation therapy to induce hyperemia in combination with transarterial chemoembolization for hepatocellular carcinoma." international journal of radiation oncology* biology* physics 108.5 (2020): 1276-1283.

Event Description

It was reported a subject passed away following transarterial chemoembolization (tace) via a journal article.Sixteen patients were enrolled the study.13 patients received single-fraction stereotactic body radiation therapy (sbrt) followed by tace within 24 hours.Median follow-up was 15.3 months.The most common toxicities were fatigue (46.2%), abdominal pain (38.5%), and nausea (38.5%).Crude rates of grade 1 or higher and grade 2 or higher toxicity were 85% and 38%, respectively.There were no grade 3 or 4 toxicities.One patient in cohort 2 died of intraperitoneal hemorrhage 4 days after tace (grade 5 toxicity), which was probably related to protocol therapy.

• Brand Name: EMBOZENE 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12158176
• MDR Text Key: 261213094
• Report Number: 2134265-2021-08849
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• 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: 06/21/2021
• 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