Critical Device Used in Heart Valve Procedure Being Recalled

Synopsis

  • 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.