Cook Medical has initiated a nationwide/global recall of its Zilver PTX Drug Eluting Peripheral Stent after receiving complaints about delivery system tip separation. Two adverse events, including one death, occurred in cases where a tip separation was reported.
The recall includes all sizes, diameters, and lot numbers of the product. These devices were distributed to medical institutions in the United States between December 13th, 2012, and April 16th, 2013. The recall is specific to the delivery system, not the stent itself, according to Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Interventional clinical division. If you are unsure if you are using this device, contact your doctor immediately.
The company has already received 13 complaints that the delivery system of the device became separated at the tip of the inner catheter while in use. Cook’s investigation identified an internal component of the delivery system used to implant the stent that did not consistently meet the correct design criteria.
Potential adverse reactions/injuries as a result of the device malfunctioning include surgery to remove the catheter tip, vascular occlusion due to an un-retrieved catheter tip, thrombosis, amputation, severe pain, possible cardiac arrest, and even death. People who have the device should stop using it immediately. Cook medical is issuing full refunds for the product
Patients with Zilver PTX stents implanted in whom the delivery system was removed safely and intact are at no risk and are 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.
Adverse events can be reported to Cook Medical or to the FDA via MedWatch at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm
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