Boston Scientific is now recalling a new stent for leg arteries after numerous complaints of no deployment or partial deployment were received by the FDA. This fundamental defect may result in vessel wall injury and / or emergency surgery to remove the partially deployed stent. The product in question is designed for use in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery (SFA) and / or proximal popliteal artery.
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What’s the problem?
June 28, 2011 – This week, the U.S. Food & Drug Administration (FDA) announced that Boston Scientific is recalling its Innova self-expanding stent system because the products may fail to deploy or only partially deploy during an operation . The Innova device is a self-expanding stent designed to treat lesions in arteries above the knee. The failure of this device could result in serious medical problems including vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent.
Due to the fact that the failure to properly deploy typically occurs during the surgical implant procedure, already implanted stents are not included in this recall.
In its announcement, the FDA said 505 devices are included in the recall, for which Boston Scientific sent a letter to overseas customers in May 2011. The administration listed the recall as a Class I event, which is the most serious type of recall notification. To date, Boston Scientific has not commented on the matter.
Boston Scientific Innova Stent Background
The Innova self-expanding stent first won European approval in March 2011. Boston Scientific started selling the devices in Europe and other countries that follow European device approval rules the next month. The company has also launched enrollment in a trial aimed at getting the Innova eventually approved on the U.S. market.
Boston Scientific’s peripheral interventions business products – which include the Innova stent – reported sales of $176 million in the first quarter of 2011, representing approximately nine percent of the company’s total sales.
Other popular peripheral intervention products sold by Boston Scientific include balloons and other devices used to treat blood vessel circulation issues outside the heart. The company’s best selling products include stents for the heart and implantable heart-rhythm devices like pacemakers and defibrillators.
How Do Stents Work?
A stent is a small mesh tube designed to open narrowed or restricted arteries to prevent them from becoming blocked in the months or years following a surgery. You may also have a stent placed in a weakened artery to make blood flow more efficient and to help prevent the artery from bursting. Stents are generally made of metal mesh, but some fabric stents known as ‘stent grafts’ are used in larger arteries.
In the legs, plaque can narrow the arteries over time, resulting in pain and cramping in the affected limbs. When this happens, the condition is called peripheral artery disease (PAD). If an individual’s case of PAD is severe, it can completely cut off blood flow to a limb and require emergency surgical intervention.
In a peripheral artery stenting procedure, a device like Boston Scientific’s Innova self-expanding stent is inserted into a peripheral artery through a catheter under local anesthesia. When the stent is deployed, blockage in the artery is dilated by a balloon mounted on the stent. The stent acts as scaffolding, keeping the artery wall stretched open and maintaining blood flow through the vessel while holding the plaque back.
Peripheral Artery Disease (PAD)
PAD occurs when the peripheral arteries of the pelvis or legs are significantly narrowed. The disease is similar to coronary artery disease (CAD) and carotid artery disease in that all three conditions are caused by narrowed or blocked arteries in various critical regions of the body. Signs and symptoms of PAD typically include:
- tiredness in the hip muscles while walking or climbing stairs.
Since many people mistake the symptoms of PAD for something else, the disease often goes undiagnosed until it is too late. Individuals with PAD have a 4 to 5 times greater risk of heart attack or stroke than people who do not suffer from the condition. Sadly, PAD can lead to gangrene and amputation if it is left untreated.
Related article: Cook Zilver PTX Stent Class Action Lawsuit
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