Cook Medical has initiated a voluntary recall of its Zilver® PTX® Drug Eluting Peripheral Stent following 13 complaints of delivery system tip separation, two adverse events, including one death.
Complaints from users have suggested that the delivery system of the Zilver® PTX® Drug Eluting Peripheral Stent may be prone to separation at the tip of the inner catheter. When this happens there is clearly potential for adverse events to occur including: possible surgery to remove the catheter tip; vascular occlusion due to an unretrieved catheter tip; thrombosis; amputation; and possible cardiac arrest.
These devices were manufactured at Cook’s facility in Limerick, Ireland and distributed to medical institutions in the United States between December 13, 2012 and April 16, 2013.
Cook’s voluntary global recall includes all sizes, diameters and lot numbers (Catalog number ZIV6*****PTX).
In its recall letter Cook says consignees should stop using the device, quarantine any inventory and return it for credit.
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® stent use a different delivery system that is not included in this recall.
Cook’s investigation identified an internal component of the delivery system used to implant the stent that did not consistently meet established design criteria. Cook has conducted an exhaustive quality assessment and audit of the affected components to ensure satisfactory performance of the delivery system in the future.
The device received FDA premarket application approval in the U.S. in November 2012. It received CE Mark clearance in August 2009 and is approved for sale in 54 countries including Japan, Australia and Brazil.
“We initiated a voluntary global recall because while the occurrence of the component separation was very low, we felt the risk to patients required us to act with an abundance of caution,” said Lyles.
Source: Cook Medical