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Cook Recalls Zilver PTX Drug Eluting Stent Due to Potential Delivery System Separation Prompts

Posted Apr 26 2013 3:06am

I covered the Cook Zilver Stent quite a bit here as it’s one that goes in the leg to help fight PAD.  The recall is for systems that have not been used and patients who have the implant are fine and do not need to worry.  Stents in the leg area are more rugged and have stealthier builds than one for the heart area obviously as the legs move and the heart is stationary.  The risk on the delivery system is very small but all are being recalled and the stent itself is ok.  It’s the catheter that has a small potential to break.  BD 

“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(R) stent use a different delivery system that is not included in this recall.”

Cook Medical Gets FDA Approval for Zilver PTX Drug Eluting Stent for the Treatment of Peripheral Arterial Disease (PAD)
Zilver Drug Coated Leg Stent for Treating PAD From Cook Medical Meets Safety Goals

Based on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a nationwide/global voluntary recall of its Zilver(R) PTX(R) Drug Eluting Peripheral Stent. Cook 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.

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 84 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). Consignees should stop using the device, quarantine any inventory and return it for credit.

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