FDA Issues Class I Recall of Zilver® PTX® Drug-Eluting Stent

FDA Issues Class I Recall of Zilver® PTX® Drug-Eluting Stent
Cook Medical Announced a Voluntary Recall One Month Ago

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FDA Approves Cook's Zilver PTX: the First Drug-Eluting Stent to Treat Peripheral Arterial Disease

Potential for Delivery System Catheter Separation Prompts Cook Medical To Initiate Voluntary Global Recall of Zilver® PTX® Drug Eluting Stent

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Zilver® PTX® Drug Eluting Peripheral Stent

May 24, 2013 -- Today the U.S. Food and Drug Administration issued a Class I recall of the Zilver PTX Drug-Eluting Peripheral Stent. One month ago, Cook Medical, the device manufacturer, issued its own voluntary recall.

It was not immediately clear as to why the FDA has now issued its own recall. A Class I recall is the most serious category, defined as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

The reason for the recall, as the FDA posted on its web site, was:

"Cook Medical received a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Potential adverse events that may occur in cases where the inner deliver catheter breakage occurs include possible surgery to remove the catheter tip, vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, possible cardiac arrest, and death."

Specifically Cook had received 13 complaints of delivery system tip separation with an occurrence rate of 0.043 percent. Two adverse events, including one death, occurred in cases where a tip separation was reported. These devices were distributed to medical institutions in the United States between December 13, 2012 and April 16, 2013. Cook initiated a voluntary global recall of all sizes, diameters and lot numbers (Catalog number ZIV6*****PTX) and warned that consignees should stop using the device, quarantine any inventory and return it for credit.

Problem Was in Delivery System
The recall, said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Interventional clinical division, is specific to the delivery system, not the stent itself. If a patient has had a Zilver PTX stent implanted and the delivery system was removed safely and intact, that patient is at no risk and is not affected by this recall. Bare metal versions of Cook Medical’s Zilver Flex® stent use a different delivery system that is not included in this recall.

Cook’s investigation identified an internal component of the delivery system used to implant the stent that did not consistently meet established design criteria. Cook has conducted an exhaustive quality assessment and audit of the affected components to ensure satisfactory performance of the delivery system in the future.

Outlook for Zilver Stent
A similar problem with the delivery system of a stent occurred back in 2004 with a recall of Boston Scientific's Taxus coronary stent. In the case of the Taxus, in a very few instances the laser-welded delivery catheter had a tendency to kink, thereby making it difficult or impossible to deflate the balloon on which the stent was mounted. The Taxus recall, like that of the Zilver, occurred shortly after the FDA approved the device.

In the case of the Taxus stent, a corrected catheter was made available immediately and the Taxus went on to become the best-selling drug-eluting stent in the world. As of this report, Cook Medical has not yet communicated a delivery date for a fixed version of the Zilver system and the company has not responded to queries from Angioplasty.Org as to an expected date for redistribution.

The complete text of the FDA recall can be read here.

Reported by Burt Cohen, May 24, 2013