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

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 03/24/2021

Event Type  Injury  

Event Description

The patient had a bard g2 ivc filter placed at an osh after trauma.She presented to me a few weeks ago due to fractured filter with piece of filter in branch of left pulm artery.The fractured ivc filter was removed and the fractured piece in the pulm artery was removed separately.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: 11574514
• MDR Text Key: 242781843
• Report Number: MW5100289
• Device Sequence Number: 1
• Product Code: DTK
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• 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): Other; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 59