Cook Medical Recalls Stent Delivery System

Medical device maker Cook Medical Inc. has initiated a voluntary recall of its Zilver PTX drug-eluting peripheral stent. The Bloomington, Ind.-based company reported that it 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.

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.

“We initiated a voluntary global recall because while the occurrence of the component separation was very low, we felt the risk to patients required us to act with an abundance of caution,” said Lyles. The U.S. Food and Drug Administration (FDA) has been made aware of the recall.

These devices were distributed to 84 medical institutions in the United States between Dec. 13 last year and April 16. Cook initiated a voluntary global recall of all sizes, diameters and lot numbers. Consignees should stop using the device, quarantine any inventory and return it for credit, the company instructed.

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

The device received FDA premarket application approval in the United States in November 2012. It received CE mark clearance in August 2009 and is approved for sale in 54 countries including Japan, Australia and Brazil. The device is manufactured at Cook’s facility in Limerick, Ireland.