On April 24, 2013, the Indiana-based Cook Medical, Inc. announced the voluntary recall of its Zilver PTX Drug Eluting Peripheral Stent due to possibly life-threatening problems with the stent’s delivery system.
What Is the Zilver PTX Drug Eluting Peripheral Stent?
A stent is a tube inserted into a blood vessel to expand it and ensure proper blood flow. They are usually used in people who have some kind of heart or circulatory ailment. Cook Medical’s Zilver PTX Drug Eluting Peripheral Stent is made of a metal mesh and is meant for insertion in one of the primary arteries along the thigh bone in people who have peripheral artery disease (PAD). The stent is coated with the drug Paclitaxel, which prevents the blood vessel from narrowing again (a condition called “restenosis”). The drug coating is what gives the Zilver PTX its “drug eluting” quality because the Paclitaxel dissolves into the blood once the stent is inserted.
The Zilver PTX Drug Eluting Peripheral Stent Might Cause Life-Threatening Side Effects
The U.S. Food and Drug Administration (FDA) approved the Zilver PTX Drug Eluting Peripheral Stent in November 2012 via its premarket approval process. However, by December 2012, Cook Medical had received 13 complaints from patients all over the world that the stent’s delivery system could separate at the tip of the inner catheter. Two adverse events were reported in the United States, and one of the American patients died. Cook Medical initiated a worldwide recall of the stents.
Symptoms that can result from a separated tip can include:
- Surgery to remove the catheter tip;
- Vascular occlusion caused by an unretrieved catheter tip;
- Cardiac arrest; and
The side effects are specific to the stent’s delivery system, so patients who were implanted with the stent and had the delivery system removed are not at risk of tip separation side effects. Cook Medical determined that the cause of the tip separation was due to a component within the delivery system not being manufactured according to its design criteria.
RLG’s Zilver PTX Drug Eluting Peripheral Stent Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Zilver PTX Drug Eluting Peripheral Stent lawsuit on your behalf if necessary. RLG will also keep you up to date on any Zilver PTX Drug Eluting Peripheral Stent class action lawsuits, FDA Zilver PTX Drug Eluting Peripheral Stent warnings, and Zilver PTX Drug Eluting Peripheral Stent FDA recall announcements. If you or a loved one was implanted with a Zilver PTX Drug Eluting Peripheral Stent and believe it caused an injury, contact RLG today.