Based on complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has recalled its Zilver PTX Drug Eluting Peripheral Stent. Two adverse events, including one death, occurred in 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.
These devices were distributed to medical institutions in the United States between December 13, 2012 and April 16, 2013. All sizes, diameters and lot numbers (Catalog number ZIV6*****PTX) were recalled. Consignees should stop using the device, quarantine any inventory and return it.
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 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
See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who Is Liable and Why?