MAUDE Adverse Event Report: C. R. BARD, INC. BARD G2 IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problems Entrapment of Device (1212); Fracture (1260)

Patient Problems Stenosis (2263); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/24/2021

Event Type  Injury  

Event Description

G2 filter placed in 2008.Patient presented with severe bilateral lower extremity chronic venous disease secondary to ivc stenosis and fractured primary leg of the filter with the fractured leg extravascular imbedded within the adjacent vertebral body.Removal of the g2 filter with retained primary leg and stent placement in the ivc and bilateral iliac veins.Fda safety report id# (b)(4).

• Brand Name: BARD G2 IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 11398471
• MDR Text Key: 234481657
• Report Number: MW5099709
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 164