MAUDE Adverse Event Report: BARD G2; FILTER

Device Problem Fracture (1260)

Patient Problems Embolism (1829); Foreign Body In Patient (2687)

Event Date 12/01/2016

Event Type  Injury  

Event Description

G2 ivc filter found to be multiply fractured (total 6 pieces 3 arms fractured and 2 legs) with one arm embolized to the right ventricle.Filter and all pieces removed except one left in an extravascular location (in excluded aaa sac).Of note, the filter was placed in 2008, however appears to have fractured and embolized within the past year.

• Brand Name: G2
• Type of Device: FILTER
• Manufacturer (Section D): BARD
• MDR Report Key: 6144430
• MDR Text Key: 61547751
• Report Number: MW5066494
• 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: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• 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
• 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: 72 YR
• Patient Weight: 150