This week, Cook Medical announced that due to a problem with the delivery system for its Zilver PTX stent, just approved by the FDA in November of last year, the company has announced a voluntary recall of the drug-eluting stent.
According to a press release, there have been 13 complaints that the delivery system of the device had separated at the tip of the inner catheter. Two adverse events, including one death, were reported. Potential adverse events include possible surgery to remove the catheter tip, vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, and cardiac arrest. The devices were distributed to 84 facilities in the United States between December 13, 2012 and April 16, 2013.
The Zilver PTX has been widely discussed at clinical meetings. VDM spoke with Dr. Michael Dake, who presented 3-year results from the Zilver PTX stent trial at VEITHsymposium 2012. VDM also recorded an interview with Dr. Dake’s co-principal investigator, Dr. Gary Ansel, about the FDA approval of the Zilver PTX.
See more about the recall and more news coming out this week in the items below.