Zilver PTX Drug-Eluting Peripheral Stent Recall Lawyers
The defective product lawyers of Hardison & Cochran are reviewing cases of injuries that may be related to the recalled Zilver PTX Drug-Eluting Peripheral Stent.
If you or a family member was implanted with this stent in the thigh prior to the initiation of the device’s recall on April 18, 2013, it’s important to contact an attorney right away. You need to make sure your rights are fully protected.
What is the Zilver PTX Drug-Eluting Peripheral Stent?
The Zilver PTX Drug-Eluting Peripheral Stent is manufactured and distributed by Indiana-based Cook Medical, Inc. The device is a self-expanding, small metal, mesh tube coated on the outside with the drug Paclitaxel.
The stent is implanted to improve blood flow in an artery in the thigh which has narrowed due to Peripheral Artery Disease. The stent acts as a scaffold. The Paclitaxel coating helps to prevent the artery from narrowing again.
The U.S. Food and Drug Administration (FDA) approved the Zilver PTX Drug-Eluting Peripheral Stent in November 2012. It was manufactured from December 1, 2012 through April 16, 2013 and distributed from December 13, 2012 through April 16, 2013.
Why Was the Zilver PTX Drug-Eluting Peripheral Stent Recalled?
Cook Medical issued a voluntary recall of the Zilver PTX Drug-Eluting Peripheral Stent on April 18, 2013.
The FDA has also issued a Class I recall of the device. This is the most serious type of recall. It involves situations in which the FDA has identified “a reasonable probability” that use of the product will cause “serious adverse consequences or death.”
The recall is based on complaints that Cook Medical received concerning the delivery system of the device separating at the tip of the inner catheter. According to the FDA, where the inner delivery catheter breakage occurs, adverse events may occur that include:
- Possible surgery to remove the catheter tip
- Vascular occlusion (blockage of a blood vessel) due to an unretrieved catheter tip
- Thrombosis (blood clot)
- Possible cardiac arrest
The recall includes all sizes, diameters and lot numbers prior to April 16, 2013.
What Should You Do Next?
If you or a loved one has been implanted with the Zilver PTX Drug-Eluting Peripheral Stent in the thigh after it was distributed on December 13, 2012, and before it was recalled on April 18, 2013, contact your doctor immediately. Additionally, you should seek help from an experienced defective products lawyer who can advise you on your legal rights and options.
The lawyers of Hardison & Cochran have many years of experience in protecting the rights of consumers. We are available to review your case at no charge. To learn more, contact us online or call (800) 434-8399 today.