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Home ► Medtronic Stent System Lawyer | Thoracic Stent Graft System Recall
The U.S. Food and Drug Administration stated that Medtronic is voluntarily issuing a global recall of a model of unused thoracic stent graft systems following the death of a patient during a clinical trial. Doctors have been told to cease utilization of the product immediately. Medtronic issued a recall in response to the results of a clinical trial of its Valiant Navion thoracic stent graft system that three separate patients who have suffered adverse effects due to the defective product.
If you or a loved one experienced any injuries or damages from using the Medtronic stent graft system, you may be eligible to file a Medtronic stent system lawsuit. Contact an experienced Medtronic stent system lawyer to discuss your legal options immediately.
The clinical study done on the Medtronic Valiant Navion Thoracic Stent Graft System displayed three patients who incurred fractures in their stents. More so, the recall noted two blood leaks and one patient death. The death was determined to be related to an aneurysm.
An in-depth look into the clinical study showed that seven out of 87 patients had enlarged stent rings beyond the design specification, though this complication has yet to be proven to cause injury. Since the recall was issued on February 17, Medtronic has received two additional complaints of patients from patients who were not included in the clinical trial. Both complaints were related to blood leaks.
The Valiant Navion is the third and latest generation of thoracic and endovascular aortic repair (TEVAR) in a single system, with covered and bare stent options. The stent system is designed to treat a wide range of patient anatomies and all lesions of the descending thoracic aorta (DTA), including thoracic aortic aneurysms (TAA), Type B aortic dissection (TBAD), intramural hematoma (IMH), penetrating atherosclerotic ulcer (PAU), and blunt thoracic aortic injury (BTAI). Approximately 14,000 people worldwide are implanted with the stent system.
The system uses a delivery catheter containing the endovascular stent graft to insert a blood vessel (femoral artery) in the groin through a small cut. After being placed in the artery, the stent graft expands and relieves the pressure on your aorta by providing a new pathway for blood flow. The Valiant Navion Thoracic Sent Graft System is used in surgeries involving a small cut in the groin instead of a bigger cut in the chest for minimal invasiveness. It intends to prevent the growth and rupture of lesions on patients’ aortas.
Medtronic is requesting customers with affected products on hand to take the following actions:
After filing a report, you should immediately get in touch with a Medtronic Thoracic Stent Graft System Lawyer to discuss your lawsuit viability.
Finding the right personal injury lawyer to represent you is an extremely important decision that should be made with caution. Your legal representative will be able to simplify the legal process and work with you to strengthen your claim. You should rest assured that your Medtronic thoracic stent system lawyer has a decorated history of success and has your best interest in mind. An experienced attorney will help you assess your damages and may be able to help you receive a higher amount of financial compensation than you previously thought possible, depending on the circumstances of your lawsuit.
It is important to discuss your case with an attorney to determine your state’s statute of limitations on your potential lawsuit. Reach out to a professional Medtronic thoracic stent system lawyer at TorHoerman law today to find out what steps you should take toward legal action.
The Civil Lawsuit Process is very time-consuming and requires keen attention to detail as well as extensive knowledge of legal jargon. It can be overwhelming for those who are already having to deal with coping with complications and trauma from their injuries.
With the help of your lawyer, you should begin gathering evidence that will support your claim in court. The amount of compensation that you may be awarded can fluctuate depending on your ability to provide evidence and prove the liability of another party for the injuries that you have suffered. Furthermore, you will need to be able to demonstrate that you attempted to treat your injuries to the best of your ability. Mitigation is a critical element to any personal injury claim. If you wait too long and the statute of limitations of your case expires, you may not be eligible to file a lawsuit or receive any compensation.
At TorHoerman Law, our team of expert personal injury attorneys specializes in Medtronic thoracic stent system lawsuits. Let us fight for you. We have won more than $4 billion in verdicts and negotiated settlements for our clients. TorHoerman Law operates on a contingency fee basis. This means that you do not owe any amount of payment until you have been justly compensated for your losses. The road to recovery from personal injuries is tough, but you do not have to go through it alone. Contact us today to find out your legal options and how we can help you.
Medtronic recalls STENT system after Trial Patient Death. (n.d.). Retrieved March 17, 2021, from https://www.law360.com/articles/1358447/medtronic-recalls-stent-system-after-trial-patient-death
Medtronic. (n.d.). Aortic Stent grafts - Valiant NAVION thoracic Stent GRAFT SYSTEM. Retrieved March 17, 2021, from https://www.medtronic.com/us-en/healthcare-professionals/products/cardiovascular/aortic-stent-grafts/valiant-navion-thoracic-stent-graft-system.html
Center for Devices and Radiological Health. (n.d.). Valiant Navion thoracic Stent GRAFT system - P100040/S036. Retrieved March 17, 2021, from https://www.fda.gov/medical-devices/recently-approved-devices/valiant-navion-thoracic-stent-graft-system-p100040s036
