News | April 30, 2013

Zilver PTX Drug Eluting Stent Recalled Due to Catheter Separation Issue

Cook Medical received 13 complaints of delivery system tip separation

April 30, 2013 — Cook Medical has initiated a global voluntary recall of its Zilver PTX Drug Eluting Peripheral Stent 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 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 medical institutions in the United States between Dec. 13, 2012 and April 16, 2013. Cook initiated a voluntary global recall of all sizes, diameters and lot numbers. 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.

For more information: www.cookmedical.com

Related Content

Titanium-Nitride-Oxide Stent Superior to Bioabsorbable DES in Acute Coronary Syndrome Patients

Image courtesy of Hexacath

News | Stents Drug Eluting | May 31, 2018
Late-breaking trial results presented at the EuroPCR Congress, May 21-24 in Paris, France, found the Optimax titanium-...
Orsiro DES Shows Lowest Two-Year Target Lesion Failure in BIO-RESORT Trial
News | Stents Drug Eluting | May 31, 2018
Two-year outcome data from the BIO-RESORT randomized controlled trial were presented in a late-breaking clinical trials...
OCT Reveals Excellent Healing Profile for Complex CAD Patients With Resolute Onyx DES
News | Stents Drug Eluting | May 29, 2018
Investigators recently unveiled clinical data from the independently run Onyx 1-Month OCT Study showing strong early...
Abbott's Xience Sierra Stent Receives FDA Approval
Technology | Stents Drug Eluting | May 25, 2018
Abbott announced it received approval from the U.S. Food and Drug Administration (FDA) for Xience Sierra, the newest...
Medtronic Launches 2 mm Onyx DES
Technology | Stents Drug Eluting | February 26, 2018
February 26, 2018 – Designed specifically for small vessels, Medtronic plc announced U.S.
Detroit Medical Center Heart Hospital Uses Michigan's First EluNIR Drug-Eluting Stent
News | Stents Drug Eluting | February 19, 2018
February 19, 2018 — The Detroit Medical Center’s (DMC) interventional cardiology team at Heart Hospital recently beca
Biotronik Symposium Highlights Differing Roles of Drug-Eluting Stents and Magnesium Scaffolds in Clinical Practice
News | Stents Drug Eluting | January 25, 2018
January 25, 2018 – Data presented at the Biotronik-sponsored...
The Abbott Absorb Bioresorbable Vascular Scaffold (BVS) bioabsorbable stent.

The Abbott Absorb Bioresorbable Vascular Scaffold (BVS).

Feature | Stents Drug Eluting | January 17, 2018 | Dave Fornell
There was no shortage of interest in bioresorbable stent technologies at the many sessions offered on this topic or b
Cordis and Medinol Announce FDA Approval of EluNIR Drug-Eluting Stent System
Technology | Stents Drug Eluting | December 13, 2017
Cordis, a Cardinal Health company, and Medinol recently announced U.S. Food and Drug Administration (FDA) approval of...
The Xience Sierra stent.
Technology | Stents Drug Eluting | November 09, 2017
November 9, 2017 — Abbott received European CE mark for Xience Sierra, the newest generation of the company's Xience
Overlay Init