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); Hemorrhage/Bleeding (1888); Vomiting (2144); Dizziness (2194)

Event Date 04/05/2020

Event Type  Injury  

Manufacturer Narrative

Anaya, daniel a.; centeno, barbara a.; kis, bella.; & kis, lilla e.(2020) hepatic adenoma rupture following portal vein embolization.Radiology case reports, volume 15 (issue 6), pages 664-667.Date of event was approximated using date of article submission.

Event Description

It was reported via a journal article that a hepatic adenoma rupture occurred.The patient underwent embolization of the anterior and posterior divisions of the right portal vein from contralateral approach with portal vein access via a peripheral segment 3 portal vein branch with embozene microspheres and non-bsc microspheres.The patient was discharged home in stable condition with minimal mid-abdominal pain at the left portal venous access site.The patient presented back to the hospital four hours later with an adenoma rupture.Treatment included a blood transfusion and embolization.Postembolization angiogram demonstrated no evidence of extravasation.The patient was discharged home 5 days after the embolization.The patient is completely asymptomatic 6 months after the hepatectomy.

• 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: 10133661
• MDR Text Key: 194498777
• Report Number: 2134265-2020-07747
• Device Sequence Number: 1
• Product Code: NAJ
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EMBOSPHERES (MERIT MEDICAL)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 31 YR