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

Device Problems Break (1069); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 08/31/2022

Event Type  Injury  

Event Description

G2 filter placed (b)(6) 2008 fractured sometime in past year (as evidenced by intact filter on ct 1 year ago) with one arm embolized to right renal vein.Filter and fragment removed today.Fda safety report id # (b)(4).

• Brand Name: G2 IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• MDR Report Key: 15348766
• MDR Text Key: 299303548
• Report Number: MW5111857
• 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: 08/31/2022

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: 09/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Other
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White