The U.S. Food and Drug Administration (FDA) has identified the Cook Medical Zenith Alpha Thoracic Endovascular Graft as a Class I recall, the most serious type of recall where there is a “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
The Zenith Alpha Thoracic Endovascular Graft is designed to treat isolated lesions in a patient’s main blood vessel that carries blood from the heart down through the chest (descending thoracic aorta) into the abdomen. The device is used for patients who have a suitable vascular (blood vessel) anatomy for endovascular repair.
Reason for Recall
Cook Medical Inc. is recalling the Zenith Alpha Thoracic Endovascular Graft because blood clots (thrombus) may form inside the device after implantation. The device is used for the treatment of blunt traumatic aortic injury (BTAI). Cook Medical also knows of reported cases where the graft became closed or blocked (occlusion) when used to treat BTAI. Thrombosis or occlusion may lead to serious adverse health consequences, even death.
Units with all existing lot numbers are affected by the recall and manufacturing dates are April 10, 2015 to January 3, 2017 and distribution dates are October 29, 2015 to March 10, 2017. In the United States, approximately 4,500 devices will be relabeled and 500 devices (18 to 22 mm) will be removed, reports the FDA.
The national personal injury law firm Parker Waichman LLP has extensive experience and success in medical device litigation. Attorneys at the firm are available to answer any questions about filing a potential lawsuit.
Urgent Medical Device Notification
Cook Medical sent an “Urgent: Medical Device Correction and Removal” notification on March 22, 2017 to all affected customers. This recall notification included a description of the issue and reason for the recall, list of affected products, and customer actions to be taken in response to the recall notice.
On June 22, 2017, Cook Medical sent an updated Urgent: Medical Device Correction and Removal” notification to all customer who are affected. This recall notification informed customers the Instructions for Use (IFU) for this device were updated to remove the indication for use in BTAI. As a result, it is vital to remove specific sizes of this device: grafts with a proximal or distal diameter of 18-22mm) that would likely be used solely for the treatment of BTAI, according to the FDA.
Cook also suggested that patients treated with the graft for BTAI indications be followed according to its updated instruction for use.
What is Endovascular Grafting?
Endovascular refers to the area inside of a blood vessel such as the aorta. Endovascular stent grafting, or endovascular aortic repair, is a newer form of treatment for thoracic aortic aneurysms that is less invasive than open surgery. Endovascular stent grafting uses a device called an endovascular stent graft.
The endovascular stent graft is a synthetic fabric tube (graft) supported by a metal scaffold (stent). During endovascular stent grafting, the endovascular stent graft is placed inside the thoracic aorta using a long, thin, soft, plastic tube called a delivery catheter.
Endovascular Aneurysm Repair
An aneurysm is a bulge in an area of an artery that has been weakened due to certain disease processes, according to the Mayo Clinic. Rather than an open aneurysm repair in which the chest/abdomen are surgically opened, the surgeon may consider a procedure called endovascular aneurysm repair (EVAR). In addition, the procedure may be referred to as a thoracic endovascular aneurysm repair (TEVAR) or fenestrated endovascular aneurysm repair (FEVAR), depending on the type of repair that is necessary.
Endovascular surgery is performed inside the aorta using catheters to place a stent surrounded with a fabric liner to reinforce weak spots. The patient may be eligible for endovascular stent grafting if the aneurysm has not ruptured and the aneurysm is five centimeters or more in size.
Although this is generally a safe procedure, as with any surgery, there are risks. Complications that can happen after endovascular aneurysm repair include leaking of blood around the graft, the graft moving away from its initial placement and the stent breaking. Complications that are rare but serious include paralysis, delayed rupture of the aneurysm, or infection, according to the Cleveland Clinic website.
Legal Information and Advice for Medical Device Problems
If you or someone you know suffered injuries regarding the use of a medical device, you may be eligible for compensation. The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).