Patient Death Prompts Recall of Cook Medical Zilver PTX Stent

Overview: Cook Medical is recalling their Zilver PTX Drug Eluting Periperal Stent following reports of adverse events, including one death. The company said it received reports of the catheter separating from the unit under certain conditions. According to Cook Medical, tip separation can lead to complications such as thrombosis and cardiac arrest. The recalled devices were distributed in the United States between December 13, 2012 and April 16, 2013.

Product: Zilver PTX drug-eluting stent

Manufacturer: Cook Medical

Delivery System Catheter Separation

Last Wednesday, Cook Medical announced that it was recalled the Zilver PTX drug-eluting stent due to reports that “the delivery system of the device had separated at the tip of the inner catheter”. The company received 13 complaints of such events. In two cases, one of which included a patient death, tip separation was reported. The company said that when there is breakage of inner delivery catheter, a number of complications may occur; this includes possible surgery to remove the tip of the catheter, thrombosis, vascular occlusion from an unretrieved tip, amputation and potential cardiac arrest. Rob Lyles, who is the vice president and global leader of Cook Medical’s Peripheral Interventional clinical division, said that the recall applies specifically to the delivery system rather than the stent. A company investigation found that one of the internal components of the delivery system used to implant the stent did not meet the established design criteria. The device was approved by the U.S. Food and Drug Administration only last November.