C.R. Bard Denali® is an IVC filter that catches blood clots in the vena cava. Unfortunately, it can break within just a few months. Patients have developed severe heart problems and required open-heart surgery.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently evaluating IVC filter cases in all 50 states, regardless of whether you have been injured or not. If you or somebody you know was implanted with an IVC filter, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Overview
Denali® is a blood clot filter that has 12 needle-like wire legs called “struts” arranged in a cone-shape. It is implanted in the inferior vena cava (IVC) to catch blood clots coming from the lower half of the body to prevent pulmonary embolisms.
Bard Denali Fracture and Embolization
In January 2015, a case report published by the Journal of Vascular Interventional Radiology described a 46 year-old woman who was severely injured by a Bard Denali IVC filter.
Six months after the Denali was implanted, the woman returned to the hospital to have it removed. She complained of a 1-week history of severe chest pain. Doctors discovered two broken pieces of the filter, including one that perforated her heart.
The woman was suffering from cardiac tamponade, a severe type of irregular heart rhythm. She required open heart surgery to remove the broken pieces.
After the piece was removed, experts examined it under an electron microscope and discovered “high-cycle metal fatigue indicating the filter design failed to withstand this patient’s natural inferior vena cava bio-mechanical motions.”
Bard Denali Class Action
C.R. Bard is facing a growing number of individual lawsuits from people who were injured by the Denali. In May 2016, a class action lawsuit was filed on behalf of everyone who was implanted with the Denali, including people who have not been injured yet. They are seeking medical tests to check on the condition and position of the filter.
Bard Denali Recall
In February 2016, C.R. Bard issued a Class II recall for 1,183 Denali filters to fix a labeling error. It was missing warnings against implanting Denali in patients with uncontrolled sepsis or nickel-titanium allergies.
What is the problem?
In 2010, the FDA issued a Safety Warning after receiving 921 adverse events involving IVC filters since 2005. In some cases, broken pieces of the filter traveled in the bloodstream and became embedded in the heart or lungs.
Many patients were severely injured or died after temporary filters were not removed. The agency now recommends removing IVC filters within 29-54 days after implantation. The risk of side effects increases the longer an IVC filter remains implanted.
IVC Filter Complications
- Fracture
- Tilting
- Movement inside the body
- Embolization of broken pieces to the heart
- Perforation through the vena cava wall
- Organ damage
- Cardiac arrest
- Cardiac tamponade
- Ventricular tachycardia (severe irregular heart rhythm)
- Death
Do I have a Bard Denali Lawsuit?
The Schmidt Firm, PLLC is evaluating IVC filter cases in all 50 states, regardless of whether you were injured or not. If you or someone you know received an IVC filter implant, please contact our lawyers immediately for a free case consultation. You may be entitled to compensation by filing a lawsuit.
Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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