Updated April 25, 2013 with additional comments from Cook Medical.
Cook Medical recalled all sizes, diameters and lot numbers of its Zilver PTX drug-eluting stents after receiving reports of 1 death and 1 patient injury possibly associated with a breakage in the catheter delivery system. It’s not clear when the devices will be back on the market, according to a company spokesman.
The adverse events have not yet been definitively tied to the noted problems with the delivery system, Cook spokesman David McCarty told MassDevice.com today, but the company chose to exercise an "abundance of caution" in pulling the Zilver PTX systems off of the shelves worldwide. Cook has asked healthcare providers to "stop using the device, quarantine any inventory and return it for credit."
Cook has received 13 complaints regarding breakage and separation of the tip of the Zilver PTX’s inner delivery catheter, some of which occurred during desktop training exercises, McCarty said. If tip separation occurs in a patient it could result in surgery to remove the tip, vascular occlusion from an un-removed tip, thrombosis, amputation or possible cardiac arrest. By Cook’s calculations tip separation has a 0.04% occurrence rate.
In a notice filed with U.S. regulators the company emphasized that the issue is isolated to the delivery system and that patients already implanted with the Zilver PTX stent itself are "at no risk." In addition, Cook’s bare metal Zilver Flex stents use a different delivery system that is not affected by the recall.
The medical device maker is taking swift action and has already identified and corrected the problem, McCarty told us. Cook is preparing to manufacture new Zilver PTX delivery systems, but will have to overcome some regulatory hurdles before getting back on the market.
"We can’t say with any definitive accuracy right now when we expect to have the device back on the market, but we’re working as fast and as hard as we can to make that as quickly as possible," McCarty said. "In some markets that could be weeks, in some markets it might take a couple of months."
Cook has shipped over 40,000 Zilver PTX drug-eluting stent systems since winning CE Mark approval in 2009, he added, but there’s no telling how many have been implanted and how many are still on shelves and must be recalled.
The Zilver PTX, which won FDA premarket approval in November 2012, was only distributed in the U.S. from Dec. 13, 2012, to April 16, 2013, according to the FDA notice. The device has been cleared on the European market since August 2009 and is approved for sale in 54 countries.
When green-lighted by the FDA, the Zilver PTX was the 1st U.S.-approved drug-eluting stent indicated for treatment of peripheral artery disease. The approval came 1 year after the FDA’s Circulatory Systems Devices Panel unanimously recommended approval for the device, which is a self-expanding drug-eluting stent coated in paclitaxel.
