The C.R. Bard Denali® is an IVC filter that catches blood clots. Unfortunately, there have been reports of filters that broke within just a few months and patients who required emergency open-heart surgery.
Need a Texas Bard Denali Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by a blood clot filter, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
The Denali® Vena Cava filter consists of twelve needle-like wire legs called “struts” that are arranged in a cone-shape. The device is implanted in the inferior vena cava (IVC), a major blood vessel that carries oxygen-depleted blood from the body to the heart and lungs. It is designed to prevent pulmonary embolisms by catching blood clots.
What is the problem?
The FDA has received over 900 of reports of people who were severely injured or died from IVC filter complications, according to a Safety Communication published in 2010.
The agency now recommends removing temporary filters within 29-54 days, if possible. However, only a small percentage of IVC filters are ever removed. The longer the filter remains implanted, the higher the risk of side effects, such as:
- Embolization of broken pieces
- Perforation of the vena cava
- Organ damage (heart, lungs, kidneys, etc.)
- Cardiac tamponade
- Irregular heart rhythm
- Cardiac arrest
Bard Denali Fracture and Embolization Resulting in Open Heart Surgery
In January 2015, the Journal of Vascular Interventional Radiology published a case report of a 46 year-old woman who was implanted with a Bard Denali IVC filter.
When she returned to have it removed six months later, she had a 1-week history of severe chest pain. During removal, two broken pieces of the filter were discovered, including one piece that perforated her heart and caused severe irregular heart rhythm known as cardiac tamponade.
The woman required open-heart surgery to remove the piece. When it was examined with an electron microscope, experts found “high-cycle metal fatigue indicating the filter design failed to withstand this patient’s natural inferior vena cava biomechanical motions.”
Bard Denali Class Action
In May 2016, a class action lawsuit was filed on behalf of everyone who was implanted with an IVC filter made by C.R. Bard, including two people who were implanted with the Denali. Lawyers say the devices are “ticking time bombs.”
In many cases, broken filters do not cause any symptoms until a piece suddenly travels to the heart and causes irregular heart rhythm, cardiac arrest, or death. The plaintiffs are seeking diagnostic tests to determine the condition and position of their filter.
Bard Denali Recall
In February 2016, a Class II recall was issued for about 1,183 Bard Denali IVC filters because the label was missing contraindications for patients with uncontrolled sepsis or hypersensitivity to nickel-titanium alloys.
FDA Warning Letter
In July 2015, the FDA sent a Warning Letter to C.R. Bard for misfiling complaints and failing to make sure Denali filters were free of toxic cleaning processing agents.
Need a Bard Denali Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Bard Denali lawyers for a free lawsuit review.