Zilver PTX Stent Systsem Recalled

Due to nearly 15 complaints, product recall attorneys at Pintas & Mullins Law Firm report that the Zilver PTX Drug Eluting Peripheral Stent is being recalled. The measure was based on investigations which found that the device can separate at the tip of the inner catheter.

Zilver’s manufacturer, Cook Medical, initiated the global recall after 13 complaints and one death were reported after a tip separation occurred. If an inner delivery catheter breakage occurs, a patient may be forced to under surgery to remove the catheter tip, experience vascular blockage, thrombosis, amputation, and possibly a cardiac arrest.

The Zilver PTX Stents were distributed to nearly 85 medical centers throughout the United States between mid-December 2012 and mid-April 2013. The recall affects all sizes, diameters, and lot numbers. Patients should stop using the stent and may return it to Cook Medical for credit.

Officials at Cook Medical highlight that the recall affects the stent’s delivery system, not the stent itself. If a patient has a Zilver PTX Stent implanted and the delivery system was safely and effectively removed, that patient is not at risk and is not affected by the recall.

The investigation conducted by Cook found that the problems stemmed from an internal component of the delivery system, used to implant the stent, which failed to meet established design criteria. The company has already initiated an exhaustive quality assessment and audit of the delivery system to ensure future design and performance quality.

The defectively designed product was manufactured at Cook’s facility in Ireland. According to the FDA, the Zilver Stent is a self-expanding, small metal and mesh tube with an outer surface coated with Paclitaxel, a drug used in chemotherapy. The tube is then implanted in an artery in the thigh, while the chemotherapy drug helps prevent the artery from narrowing. Any patients experiencing problems with this device is encouraged to contact the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

In 2004, Boston Scientific initiated a Class I recall (referring to products that pose a direct threat of serious injury or death) of its TAXUS coronary stent systems. As in the Cook Medical recall, the 2004 measure affected only the stent’s delivery system, not the device itself. The recall was established as a Class I because it was meant for use in patients with blocked coronary arteries undergoing angioplasties.

The TAXUS system had the potential to impede balloon deflation during the angioplasty procedure, which can lead to significant patient complications, including coronary artery bypass graft surgery and death. In fact, there were at least three deaths associated with this defect, along with nearly 45 serious injuries. The 2004 recall involved nearly 100,000 stent systems, and cost Boston Scientific about $100 million.

Lawsuits have also been mounting over Stryker’s Wingspan Brain Stent System, which was approved for patients at risk for strokes. It was ultimately found that these systems actually cause patients to have an even greater risk of stroke and death compared to patients on traditional drug therapies.

In 2011, a study in the New England Journal of Medicine found that there was a more than 2.5-fold increase in strokes and deaths in patients implanted with the Wingspan system. Of the 450 patients studied, those who underwent the brain stent procedure had a 14.4% greater risk of stroke or death within 30 days, which grew to 20% at one year. Those undergoing traditional drug therapies had a 5.8% and 12.2% risk, respectively. After the publication of this study, Public Citizen petitioned the FDA to revoke the Wingspan system, and called on Stryker to recall the device.

Stent system lawyers at Pintas & Mullins Law Firm encourage anyone seriously injured by a stent delivery system to contact a skilled attorney as soon as possible. We have decades of experience advocating on behalf of those injured by defective devices, and can ensure you will receive the largest settlement and best representation possible.