Critical Device Used in Heart Valve Procedure Being Recalled
- About 2.5 percent of the U.S. population will require a heart valve replacement. According to the American Heart Association, there is a common, minimally invasive surgical procedure called transcatheter aortic valve replacement (TAVR) to assist with this.
- This procedure repairs a heart valve without removing the old, damaged valve. Instead, it wedges a replacement valve into the aortic valve’s place.
- Edwards LifeSciences is recalling its Certitude Delivery System, the tool used in a TAVR procedure, due to a molding overflow defect in the button valve within the loader which could detach during placement of the delivery system and potentially embolize into the patient.
- The FDA has identified a Class I recall on the delivery system, the most serious and urgent type of recall because this device may cause a magnitude of injuries or death.
- According to the American Heart Association, this procedure is fairly new and is FDA approved for people with symptomatic aortic stenosis who are considered an intermediate or high-risk patient for standard valve replacement surgery.
- Defective medical device cases are complex and can place consumers in a vulnerable place. Medical device recall lawyers can help.
Valve Replacement Device Used in Common Heart Procedure Recalled
Amongst other things, the U.S. Food and Drug Administration (FDA) is tasked with ensuring that the American public is protected from unsafe medical devices. Thanks to this diligent, lengthy, and costly process, most of the medical devices entering the market for consumers are safe; however, when a defective or unsafe medical device is distributed to consumers, the results are often catastrophic, significantly altering individual lives and the lives of families.
Edwards LifeSciences is recalling its Certitude Delivery System used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically used during a transcatheter aortic valve replacement (TAVR). This procedure is new and is FDA approved for people with symptomatic aortic stenosis who are considered an intermediate or high-risk patient for standard valve replacement surgery. About 2.5 percent of the U.S. population need valve replacement.
According to the recall report from the FDA:
“The Certitude Delivery System includes a balloon catheter that expands a compressed (crimped) THV, a loader that delivers the THV through the guiding tube, and extension tubing. During a procedure, the physician will first crimp the THV onto the balloon of the Certitude Delivery System. The Certitude Delivery System is then inserted into the body, usually during a transapical (inserted through small incision under left breast) or transaortic (inserted through small incision in the top right side of the chest) approach. The THV is then deployed through the guiding tube to the site of the native stenotic aortic valve, where it is expanded and fixed in place.”
The American Heart Association reports that this is a fairly common, minimally invasive surgical procedure that repairs a heart valve without removing the old, damaged valve. Instead, it wedges a replacement valve into the aortic valve’s place. The Association goes onto to explain that, “Somewhat similar to a stent placed in an artery, the TAVR approach delivers a fully collapsible replacement valve to the valve site through a catheter. Once the new valve is expanded, it pushes the old valve leaflets out of the way and the tissue in the replacement valve takes over the job of regulating blood flow.”
This recall was specific due to a molding overflow defect in the button valve within the loader. The recall report states that the overflow material could detach during placement of the delivery system and potentially embolize into the patient. Such an embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. In dire situations, severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result.
Who May Be Affected
Hospitals and health care professionals performing a transcatheter aortic valve replacement using an Edwards Certitude Delivery System manufactured between November 22, 2016 to July 10, 2017 may be affected. In addition, patients undergoing a transcatheter aortic valve replacement using an Edwards Certitude Delivery System manufactured between November 22, 2016 to July 10, 2017.
The recalling company is responsible for promptly notifying each of its affected direct accounts (that is, distributors, contractors, customers) about a recall and minimize health consequences by providing instructions on what action(s) need to be taken. On July 21, 2017, Edwards LifeSciences sent affected customers a “Recall Notification Letter” informing them of the device’s risks. In the letter, Edwards LifeSciences directed customers to:
- Complete the “Acknowledgement Form” that accompanied the Recall Notification Letter.
- Check all inventory for affected models of the Certitude Delivery System.
- Return the “Acknowledgement Form” and all affected models of the Certitude Delivery System to Edwards LifeSciences as indicated in the Recall Notification Letter.
If you have questions about any recall forms you may have received, connect with Wagner Reese by submitting our online form, and our attorneys will review your information, and respond promptly. If you feel this requires urgent medical attention, please contact your health care professional immediately.
Defective Medical Device Claims
Lawsuits over unsafe or faulty medical devices are usually handled under product liability, an area of the law focused on products used by consumers. Experienced Indianapolis product liability lawyers typically focus on one or more of three major types of product liability claims on behalf of their clients:
- Manufacturing Defects;
- Design Defects; and/or
- Improperly Marketed/Defective Drugs.
Federal law requires device manufacturers to ensure their products are safe and doctors, hospital directors, and surgeons should be aware of any recalls and defects. If a person has reasonable legal basis, they may bring multiple types of claims, including medical malpractice, against those who have caused injury or harm.
In the year 2018, most people are able to go on to live a full and healthy life after a common heart surgery like this. But when companies provide faulty or haphazard equipment, tools, and devices needed in these procedures or medical authorities don’t follow recall orders, patients’ lives can be changed forever.
If you or a loved one were injured as a result of this defective device or others, even if recalled, you should contact one of our Indiana medical device recall lawyers immediately.
Experienced Defective Medical Device and Product Liability Lawyers
Defective product cases are complex and can place consumers in a vulnerable place. Our experienced defective drug and medical devices, product liability, and medical malpractice attorneys at Wagner Reese can help restore the balance of power, providing you the legal support and advice you need so that you can focus on your own health and healing.
Connect with us by submitting our online form, and our attorneys will review your information, and respond promptly. If you wish to speak directly with us, please call (888) 204-8440.