MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR

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

Patient Problems Chest Pain (1776); Embolism (1829); Perforation (2001); Respiratory Distress (2045)

Event Date 12/03/2010

Event Type  Injury  

Event Description

A greenfield filter was implanted on (b)(6) 2004.On (b)(6) 2010 it was noted that perforation and pulmonary embolism (pe) had occurred.No further patient complications were reported.

Event Description

A greenfield filter was implanted on (b)(6) 2004.On (b)(6), 2010 it was noted that perforation and pulmonary embolism (pe) had occurred.No further patient complications were reported.It was further reported the inferior vena cava (ivc) filter was in stable position as of (b)(6) 2009.The patient had pe post ivc filter placement in the past.The patient noted she had two ivc filters in place.There was no ivc thrombosis nor ivc filter thrombosis.On (b)(6) 2010, the patient had chest pain and difficulty breathing.The patient had v/q scan which indicated strong suspicion for pulmonary embolism.The patient was discharged on (b)(6) 2010.Computed tomography (ct) scan on (b)(6) 2017 revealed that the ivc filter tip was at the level of the l1-l2 intervertebral disc and their hooks were at the level of the midportion of the body of the l3 vertebra in the ivc.Three of the tips of the posterior hooks appeared to be penetrated outside of the ivc lumen without evidence of adjacent hematoma or soft tissue mass.

• Brand Name: GREENFIELD
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9827558
• MDR Text Key: 183487793
• Report Number: 2134265-2020-03201
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• 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: 04/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR