Patients who received a Crux IVC Filter may be at an increased risk of suffering life-threatening health complications including filter fracture, device migration, perforation of the vena cava, pulmonary embolism and death.
Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Overview
The use of inferior vena cava filters has increased dramatically over the past 30 years. In 1979, about 2,000 filters were placed in patients at risk of pulmonary embolism (PE). By 2007, that number jumped to approximately 167,000 filters implanted each year. Some are designed for short-term (retrievable/temporary) use, while others are intended for permanent implantation.
What is the Crux IVC Filter?
The Crux Vena Cava Filter (Crux VCF) is used to prevent recurrent pulmonary embolism in patients who are unable to take anticoagulant medications. The device resembles a metal cage and is surgically implanted into a patient’s inferior vena cava (IVC), the vein that returns oxygen-depleted (blue) blood to the heart from the lower body. The Crux Vena Cava Filter is manufactured by Volcano Corp. and was approved by the FDA in Nov. 2013.
FDA Warning on IVC Filters
In August 2010, the U.S. Food & Drug Administration (FDA) issued a warning [1] that recommended against leaving IVC filters implanted for extended periods due to their potential to cause severe health complications. FDA warned healthcare professionals that the devices are for short-term use only and should be removed once the blood clot risk has passed.
“The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides,” the warning reads. “Known long-term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.”
Vena Cava Filter Complications
- Fracture of the IVC filter
- Perforation, Puncture, or Serious Damage to the Heart, Lungs, or Vena Cava
- Internal Bleeding
- Cardiac or Pericardial Tamponade
- Ventricle Tachycardia
- Lower Limb DVT
- Hematoma or Nerve Injury at the Puncture Site
- Constant and Severe Pain in the Heart, Chest or Elsewhere in the Body
- Pulmonary Embolism
- Respiratory Distress
- Infection
- Shortness of Breath
- Death
Has There Been a Recall?
The Crux Vena Cava Filter has not been recall in the U.S. or any other country. However, a similar device made by Boston Scientific -- the Stainless Steel Greenfield Vena Cava Filter -- was recalled in 2005 after reports of detachment at the bond between the carrier capsule and the outer sheath, increasing the risk of pulmonary embolism.
At least 8 adverse events were linked to the Greenfield IVC Filter, 2 of which involved serious patient injury requiring intervention and one which was reported as a death. The recall affected approximately 18,000 filters.
Related Articles:
See all related medical device litigations we've covered.
Do I Have a Crux Vena Cava Filter Lawsuit?
The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in IVC filter lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
