Based on its investigation into complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a global recall of its Zilver PTX Drug Eluting Peripheral Stent. The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
Cook received complaints of delivery system tip separation. Adverse events, including one death, occurred in some cases where a tip separation was reported. Potential adverse events that may occur in cases where inner delivery catheter breakage occurs include: possible surgery to remove the catheter tip; vascular occlusion due to an unretrieved catheter tip; thrombosis; amputation; and possible cardiac arrest.
The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding, small metal, mesh tube with the outer surface coated with the drug Paclitaxel that is implanted in an artery of the thigh. The Paclitaxel coating helps prevent the artery from narrowing again. The Zilver PTX Drug-Eluting Peripheral Stent acts as a scaffold to hold open a narrowed artery caused by Peripheral Artery Disease in the legs and to improve blood flow.
These devices were distributed to medical institutions in the United States between December 13, 2012, and April 16, 2013. The recall affects all sizes, diameters, and lot numbers (Catalog number ZIV6*****PTX). Consignees should stop using the device, quarantine any inventory, and return it for credit.
The recall 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.
See the Recall