MAUDE Adverse Event Report: B BRAUN VENATECH LP IVC FILTER

Model Number VENATECH LP

Device Problem Partial Blockage (1065)

Patient Problems Dyspnea (1816); Pain (1994); Skin Discoloration (2074); Swelling (2091); Thrombosis (2100); Impaired Healing (2378); Numbness (2415)

Event Date 06/15/2016

Event Type  Injury  

Event Description

Bilateral swelling in both legs, extreme shortness of breath.Legs have become discolored and have constant numbness and pain.Visible collateral veins have formed on my abdominal walls.Legs are constantly swollen and wounds heal poorly/not at all.Ct and mri has confirmed near complete blockage of ivc filter resulting in thrombosis of the inferior vena cava and both iliac veins.

• Brand Name: VENATECH LP IVC FILTER
• Type of Device: IVC FILTER
• Manufacturer (Section D): B BRAUN
• MDR Report Key: 7079012
• MDR Text Key: 93747535
• Report Number: MW5073711
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/30/2017

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?: No
• Device Operator: No Information
• Device Model Number: VENATECH LP
• Device Catalogue Number: 5010024
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Weight: 88