Were you Injured From Your Gore Excluder AAA Endoprothesis Procedure

The U.S. Food and Drug Administration (FDA) recently announced a Class II recall of the Gore Excluder AAA Endoprosthesis, a device that doctors use primarily to treat abdominal aortic aneurysms. It’s been associated with reports of leading end catheter component separations, which can lead to health complications including endoleaks and pelvic ischemia (lack of blood flow to the pelvis).

Though the product remains on the market, manufacturer W. L. Gore & Associates Inc. updated its instructions for use with a new warning concerning the potential for catheter leading end separation, along with other warnings concerning possible catheter breakage and premature deployment.

Chaffin Luhana medical device injury lawyers are currently investigating cases in which patients suffered from injuries related to the Gore Excluder AAA Endoprosthesis.

What is an Abdominal Aortic Aneurysm?

An aneurysm of any kind occurs when an artery, which carries blood from the heart to other areas of the body, weakens in one area. Pressure from inside the artery may force that weakened area to enlarge or balloon outward, creating a bulge and potentially affecting blood flow. A weakened area like this might eventually rupture, causing internal bleeding that may be life-threatening.

An abdominal aortic aneurysm (AAA) is a specific type of aneurysm that occurs in the aorta—the largest blood vessel in the body. The aorta runs from the heart through the center of the chest and the abdomen, where it then splits into two iliac arteries that move through the lower abdomen and into the legs. An AAA occurs when the aorta bulges out in the abdominal area, potentially affecting blood flow to the pelvis and legs.

There are two main health concerns with this type of aneurysm:

1. Rupture: The weakened area may eventually rupture, allowing blood to burst out into the body.
2. Dissection: As blood pumps through the artery and past the weakened area, it may split the layers of the artery wall, allowing a build-up of blood that leaks into that space and further splits the artery wall. This can lead to a lack of blood flow (ischemia) to the organs or a rupture.

What Are the Symptoms of an Abdominal Aortic Aneurysm?

An AAA can exist for some time before creating any symptoms. If the ballooned area remains small, it may not cause any problems. If it grows, however, it may eventually create symptoms including:

• Deep, constant pain in the abdomen or at the side of the abdomen
• Back pain
• Pulse (like a heartbeat) felt near the bellybutton

If the aneurysm ruptures, symptoms may include:

• Clammy or sweaty skin
• Sudden pain in the abdomen or back
• Pain spreading from the abdomen to other areas, like the back, legs, pelvic, and buttocks
• Increased heart rate
• Shock or loss of consciousness

These types of symptoms warrant immediate medical attention, as an aneurysm—particularly a ruptured one—can be life-threatening.

What Causes an Abdominal Aortic Aneurysm?

According to the Society for Vascular Surgery, about 200,000 people are affected by AAAs in the U.S. every year. A ruptured AAA is the 15th leading cause of death in the general population and the 10th leading cause of death in men over the age of 55.

The condition is genetic and often runs in families. Other potential causes include:

• Atherosclerosis (hardening and narrowing of the arteries): This occurs when fat and other substances build up inside the arteries, causing them to become narrow and inflexible.
• High blood pressure: High blood pressure puts additional strain on the artery walls, potentially weakening them and creating areas where an AAA may occur.
• Blood vessel diseases: Any diseases that damage the blood vessels may increase the risk of an AAA.
• Trauma: Severe trauma, such as that which may occur in a car accident, may cause an AAA.

Risk factors for an AAA include a family history of the condition, smoking, being over the age of 65, being a white male, and having suffered an aneurysm in another large blood vessel.

How Is An Abdominal Aortic Aneurysm Treated?

The goal of treatment for an AAA is to prevent it from rupturing. If the aneurysm is small and creating no symptoms, doctors typically recommend a period of watchful waiting. If the bulge is 1.9 to 2.2 inches or larger, however, and it’s growing fast, doctors are likely to recommend surgery.

The type of surgery used to treat AAA include:

Open Surgery

The doctor makes an incision in the abdomen and removes the damaged section of the aorta, replacing it with a synthetic tube (called a graft) that is sewn into place. This requires stopping the blood flow through the blood vessel while the repair is taking place. The surgery is performed under general anesthesia and can take 2-4 hours to complete. Recovery can take a month or more.

Endovascular Repair

This is a less-invasive form of AAA repair. It involves inserting a graft inside the diseased aorta—in essence, “shoring up” the blood vessel to make it stronger. Rather than making a large incision in the abdomen, the doctor makes a small incision in the leg and threads a small catheter through the artery into the aorta.

He then pushes the graft, which is usually a woven tube covered by a metal mesh support, through the catheter to the site of the AAA. Once there, the doctor can expand and fasten the graft in place inside the aorta. There it remains permanently, reinforcing the weakened section and helping to reduce the risk of a rupture.

Endovascular repair may take place under general, regional, or local anesthesia, and typically takes from one to three hours to complete. Recovery is typically shorter, with most patients returning to normal activity within six weeks.

Some people are not good candidates for endovascular repair, but in general, it is used more often because it is easier on the patient and provides a shorter recovery period. It does require more ongoing monitoring to make sure the repair is performing as it should. If your suffering unexpected injuries from either type of surgery don’t hesitate to contact our experienced surgical error injury accident attorneys. 

What is the Gore Excluder AAA Endoprosthesis?

The Gore Excluder AAA Endoprosthesis is a device designed for use in endovascular AAA repair or Infrarenal Aortic Aneurysms . It was first released in Europe in 1997 and received FDA approval for use in the USA on November 6, 2002.

The device consists of an endovascular stent-graft that helps seal off the aneurysm while creating a new path for blood flow through the artery. Surgeons insert the device through a small incision in the leg using a catheter. Once the graft is positioned where it needs to be, the device has a delivery system that “intuitively enables repositioning of the stent-graft,” according to Gore Medical.

The original Gore Excluder AAA Endoprosthesis is a two-piece, bifurcated graft that lines the aorta and extends from below the renal (kidney) arteries into both iliac arteries. It’s made of ePTFE (expanded polytetrafluoroethylene) with an outer metallic support structure known as a stent.

To implant the device, a surgeon delivers it to the abdominal aorta in two sections:

1. Trunk: This is the larger section of the stent that is placed inside the aorta just below the renal arteries. It also includes one full leg that extends into one iliac artery.
2. Leg: This is placed in the other iliac artery to form a complete graft.

What is the Gore Excluder Iliac Branch Endoprosthesis?

The Gore device is what is known as a “modular” system because it consists of several different components that can be used for different types of AAA. In 2013, for instance, W. L. Gore & Associates announced it had received FDA approval for several new extender components meant to provide physicians with options in treating various sizes of arteries.

In 2016, the manufacturer again announced FDA approval of its Excluder Iliac Branch Endoprosthesis for the treatment of common iliac artery aneurysms (those occurring in the iliac arteries) or aortoiliac aneurysms (where both the aorta and iliac arteries are swollen).

To understand this new iliac device, it helps to look more closely at the iliac arteries. The so-called “common” iliac arteries are two large arteries that originate from the aorta around the area of the lower back, one going to the left side of the pelvis and one on the right. They each extend down through the pelvis, ending at the sacroiliac joint, and eventually split into two blood vessels called the external and internal iliac arteries.

This Excluder Iliac Branch Endoprosthesis was designed to be used in conjunction with the Gore Excluder AAA Endoprosthesis to isolate the iliac artery and preserve blood flow in the other iliac arteries. Indeed, many patients that suffer from an AAA also have related issues in the iliac arteries that need to be addressed.

Similar to the original device, the Gore Excluder Iliac Branch Endoprosthesis is a two-piece, bifurcated graft that lines the common iliac artery that extends into both the external and internal iliac arteries. It’s connected to one or both sides of the original Gore Excluder AAA Endoprosthesis through the use of a bridge device.

Like the original, this device is also delivered in two sections—one is placed within the common iliac artery and extends into the external iliac artery. The other is placed within the internal iliac artery. A patient treated with this device would, in the end, have a total of four pieces to form a double bifurcated endovascular graft.

Why Was the Gore Excluder AAA Endoprosthesis Recalled?

In January 2020, Gore Medical sent out an Urgent Medical Device Safety Correction/Field Safety Notice to vascular surgeons, cardiologists, and other medical professionals informing them of safety issues with the Gore Excluder AAA Endoprosthesis and Gore Excluder Iliac Branch Endoprosthesis.

In that letter, the company revealed that from January 2013 to August 5, 2019, it received 346 reports of leading end catheter component separations of the Excluder device. Of those events, 30 reported immediate health consequences and one long-term health consequence (pelvic ischemia).

Gore investigated the events and identified two types of failure modes:

• Unbonded leading end catheter components
• Breakage (separation) of leading end catheter components

The company noted that the majority of the 30 events occurred in failure modes “other than” confirmed unbonded leading end catheter component, when the devices were used in challenging anatomies, and/or when surgeons used them in ways that are warned against in the instructions for use,.

Potential risks to patients from these issues may include:

• Additional intraoperative procedure time
• Additional intraoperative and/or secondary surgical or endovascular procedures
• Endoleaks
• Iliac artery occlusion
• Iliac dissection
• Iliac rupture
• Leading end catheter component retention
• Pelvic ischemic events
• Surgical bypass
• Surgical cut downs
• Surgical conversion
• Unintentional/premature endoprosthesis deployment and wound infection at the cut down site

Gore noted that premature deployments of the graft were reported in a few events, and warned surgeons to “observe all warnings” when using the device. The company added that no long-term health consequences had been reported related to patients with retained components (pieces of the device left behind).

Did Gore Fix the Problem?

Gore maintains that its devices are safe when used in accordance with the instructions and did not remove them from the market. The company added in its field safety notice that patient benefits associated with the Excluder devices being available for use “are much greater than the potential low patient risks and low frequency of leading end catheter component separation or breakage events….”

Gore took corrective actions, however, to help reduce the risk of patient harm. These included the following:

• In 2016 and 2019, Gore implemented manufacturing process improvements to reduce the rates of unbonded leading end catheter components.
• At the time of the recall, Gore announced it would be updating its Instructions for Use (IFU) to include a new warning concerning the potential for catheter leading end separation or breakage, as well as additional warnings stating that catheter breakage and premature deployment had occurred and could result in patient harms.
• The updated instructions would also include additional procedural steps related to confirming that all catheter components are removed from the patient and recommended materials to have on hand.

Gore asked physicians to review the changes and acknowledge having received them and advised them that when using the devices against IFU warnings, to balance the risk of treatment with the risks of not treating the patient with the Gore devices.

Types of Injuries Associated with Gore Excluder AAA Endoprosthesis

Potential injuries associated with the Gore Excluder AAA Endoprosthesis may include:

• Blood vessel trauma
• Excessive bleeding
• Iliac artery occlusion, dissection, or rupture
• Catheter components left behind in the body
• Infection

Gore Excluder AAA Endoprosthesis Lawsuits

If you or a loved one was injured in a procedure with the Gore Excluder AAA Endoprosthesis, you may be eligible to file a Gore Excluder AAA Endoprosthesis lawsuit to recover damages. Contact Chaffin Luhana is now investigating these cases and invites you to call today at 888-480-1123.