The AFX Endovascular AAA System (AFX System) has recently been recalled due to reports of serious side effects, including endoleaks and subsequent failure of the system. If you or a loved one have experienced complications after being treated for an abdominal aortic aneurysm with the AFX System, you may be entitled to compensation for medical bills, lost income, and pain and suffering, among other losses. We are currently working with experienced AFX System lawyers across the country. They charge no fee unless you get an award or settlement. For a free (no obligation) case evaluation, call our toll free number 24/7 or fill out a contact form online.

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What is the AFX Endovascular AAA System?

AFX Endovascular AAA SystemThe AFX Endovascular AAA System (AFX System) was developed by Endologix, Inc. to treat abdominal aortic aneurysms (AAA). This condition occurs when the largest blood vessel in the body (the aorta) becomes thin and weakened, which in turn could cause the vessel to bulge and possibly rupture. The AFX System is comprised of a metal stent surrounded by a flexible polymer casing tube that is sized to fit inside the aorta and provide support to the blood vessel to address this issue. When placed inside the aorta, blood flows through the stent instead of the aneurysm, thus reducing the risks of further weakening or rupture of the aneurysm. Placement of the AFX System requires a surgical procedure known as endovascular aneurysm repair (EVAR).

Why is the AFX System Allegedly Dangerous?

abdominal aortic aneurysmThe AFX System was initially approved by the FDA in 2011, and since that time a number of serious side effects have been reported in connection with the device. The most common complication reported includes what is called a Type III endoleak. This occurs when blood continues to flow through the weakened aorta vessel after the placement of the AFX System. This blood flow can increase the likelihood of an aortic aneurysm bulging. If left untreated, an endoleak can result in rupture of the aneurysm, severe internal bleeding, and even death.

On July 20, 2018, Endologix announced a recall of its AFX System due to continued reports of dangerous endoleaks. The Food and Drug Administration (FDA) posted notice of the recall on its Medical Device Recall webpage. The recall has been classified by the FDA as a Class I recall, meaning that the devices may cause serious injury or death. While the FDA continues to investigate the cause of Type III endoleaks, it is thought that the cause may be due to failure of the AFX System to stay in place.

What is an Endoleak?

An endoleak occurs when blood leaks back into an aneurysm after an endovascular repair, and it is the most commonly reported complication of an EVAR procedure. It has been reported to occur in 10% to 30% of the time after endovascular stent placement and can lead to serious injuries if not treated promptly. There are five classifications of endoleaks, each having its own indications for treatment. Type III endoleaks are generally associated with a defect or misalignment between the components of endografts and stent devices. The leak causes systemic pressure within the aneurysm sac that increases the risk of rupture. As a result, Type III endoleaks require urgent medical attention. Oftentimes, patients who suffer from a Type III endoleak will have to undergo invasive surgical procedures to correct the issue.

What are the Side Effects of a Type III Endoleak?

man with chest pain after AFX Endovascular AAA System implant

Patients who suffer a Type III endoleak may have no symptoms at all. Sometimes, symptoms can include chest pain, pressure or swelling. The condition is most often diagnosed during routine follow-up appointments. For this reason, it is important for patients who have been treated with the AFX System to undergo regular monitoring and imaging studies, such as CT scans, to make sure that the device is working properly.

Are There AFX System Lawsuits?

AFX Endovascular AAA System LawsuitDue to the number of adverse events and side effects being reported, injured patients and families across the county have been hiring AFX System lawyers to investigate these cases. While these suits are still in the beginning stages, law firms have been taking these cases and investigating the dangers associated with the AFX System, including Type III endoleaks. If you have been treated with the AFX System and suffered an endoleak, it is important to consult an experienced AFX System lawyer who can help assess your potential case.

Contact an Experienced AFX System Lawyer Today!

AFX Endovascular AAA System LawyerIf you or a loved one have suffered from complications after undergoing surgical treatment for an abdominal aortic aneurysm with the AFX Endovascular AAA System, you may be entitled to compensation for medical expenses, lost income, and pain and suffering, among other losses. We are working with experienced AFX System lawyers across the country that handle these cases. There is no legal fee unless you receive a settlement or award. For a free (no obligation) case evaluation, call our toll free number anytime at 1-800-992-6878 or fill out a contact form online.

Sources:

  1. https://endologix.com/united-states/products/afx/
  2. https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm623439.htm
  3. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm577859.htm