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

Device Problem Positioning Problem (3009)

Patient Problem Perforation (2001)

Event Date 01/30/2019

Event Type  Injury  

Event Description

On (b)(6) 2005 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2009 a computed tomography (ct) scan of the abdomen showed that the greenfield vena cava filter showed no abnormalities.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen showed intravenous vena cava (ivc) filter was present with the apex at lower margin of l1 located posterior intraluminal ivc.Distal limbs were slightly peripheral approximately 2 millimeter anteriorly, on the left posteriorly.

• 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 CORPORATION; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10448533
• MDR Text Key: 204206743
• Report Number: 2134265-2020-11657
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• 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
• Patient Age: 57 YR