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

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

Patient Problems Embolism (1829); Perforation (2001); Thrombosis (2100)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

Date of implant and date of explant unknown, aware date was used as estimate.Journal article: chen, jun, et al."greenfield stainless steel vena cava filters on computed tomography follow-up." journal of vascular surgery: venous and lymphatic disorders (2020).[(b)(4)].

Event Description

Reported via journal article.It was reported via journal article that there was a thrombus, embolism and perforation.Ninety-three patients with ct studies obtained for other reasons after greenfield ivc filter placement (2007-2014) were retrospectively studied.Patients' demographic data, procedural characteristics, and imaging studies were reviewed and factors associated with perforation rates were analyzed.Results: a total of 190 follow-up ct imaging studies were available for review.In total, filter-associated ivc thrombus was seen in 10 patients and pulmonary embolism breakthrough was seen in 4 patients via contrast-enhanced ct.Perforation was evident in 18 patients.No symptomatic perforation and no strut fracture were documented.

• Brand Name: GREENFIELD
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10159246
• MDR Text Key: 195296427
• Report Number: 2134265-2020-07810
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2020

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: 05/21/2020
• Initial Date FDA Received: 06/16/2020
• 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