The Rex Medical (Argon Medical) Option™ ELITE IVC filter should be removed as soon as a patient is not at risk of a blood clots in the lungs. The longer it remains implanted, the higher the risk of filter fracture, migration, and other serious complications.
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
Argon Medical Devices Inc. sells the Option™ Elite inferior vena cava (IVC) filter, which was designed by Rex Medical. It is implanted in a patient’s body to catch blood clots before they get trapped in the lungs and cause a pulmonary embolism.
FDA Approves New Delivery Method
In January 2014, Argon Medical received FDA clearance for a new “over-the-wire” delivery technique, which helps doctors center the Option ELITE within the vena cava.
What is the problem?
The Option ELITE is a temporary IVC filter that should be retrieved as soon as the patient is no longer at risk of a pulmonary embolism. The longer it remains in a patient’s body, the higher the risk of complications.
In May 2014, the FDA recommended retrieving temporary IVC filters within 29-54 days of implantation. In August 2010, the FDA also warned that temporary IVC filters had been linked to hundreds of severe adverse events, including filters that broke, migrated, or perforated the vena cava.
Option IVC Filter Lawsuits in Texas
Argon Medical Devices is facing several lawsuits in Texas from people who were injured by the Option ELITE. In August 2016, a lawsuit (PDF) was filed in Dallas County Circuit Court by a man who has an Option IVC filter permanently embedded in his body. According to the complaint:
“As long as the Option filter remains embedded in his vena cava, Plaintiff is at risk for future thrombosis, filter fractures, migrations, perforations, and tilting. He faces numerous health risks, including the risk of death.”
Another lawsuit (PDF) was filed in October 2016 by a woman who also has an Option IVC filter permanently embedded in her body. The filter is impossible to remove because it perforated through her vena cava. It is also causing blood clots in her legs, chronic pain, swelling, vein damage, and circulation problems.
Option ELITE IVC Filter Safety Risks
According to the Instructions for Use (PDF), the Option ELITE vena cava filter has been linked to the following severe complications:
- Perforation of the vena cava
- Organ damage
- Incorrect positioning of the filter
- Filter migration or movement
- Circulation problems
- Bleeding and hematoma
- Deep vein thrombosis (DVT)
- Infection
- Breathing problems
- Cardiac arrhythmia (irregular heart rhythm)
- Heart attack
- Stroke
- Kidney failure
- Filter fracture
- Inability to retrieve broken filter
- Death
Complications
Because the Option ELITE is made of nitinol (nickel-titanum alloy), patients who are sensitive to these metals could have allergic reactions. When serious complications occur, patients may need additional surgery or emergency medical intervention. In some cases, filters that broke or migrated are impossible to remove without endangering the patient’s life.
Do I have a Option ELITE 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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