MAUDE Adverse Event Report: BARD G2X; FILTER

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/15/2017

Event Type  Injury  

Event Description

G2x filter placed in 2009 found recently to be fractured and embolized.One fragment retained locally (half of leg), one embolized to left pulmonary artery (other half of leg) and one to the right ventricle entirely embedded in tissue of septum and moderator band.Pt asymptomatic.Removed all but cardiac fragment which is inaccessible, have recommended leaving in place with serial fu.Ct surgery consult said same.

• Brand Name: G2X
• Type of Device: FILTER
• Manufacturer (Section D): BARD; tempe AZ
• MDR Report Key: 6339165
• MDR Text Key: 67825928
• Report Number: MW5067935
• Device Sequence Number: 1
• Product Code: DTK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 59