MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2; IVC FILTER

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/08/2020

Event Type  Injury  

Event Description

G2 ivcf placed in 2006 found to be multiply fractured with fragments in right and left pulmonary artery and right internal iliac vein.Filter and all fragments removed successfully today.Fda safety report id # (b)(4).

• Brand Name: G2
• Type of Device: IVC FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC. ; tempe AZ
• MDR Report Key: 9581239
• MDR Text Key: 174881706
• Report Number: MW5092186
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• 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
• 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: 33 YR
• Patient Weight: 53