The Zilver PTX Stent is made by Cook Medical, and it was approved by the FDA in November 2012 for use in patients who have peripheral artery disease (PAD). Peripheral artery disease a circulatory condition which causes the arteries to become narrow, cutting off blood supply to the legs.
The Zilver PTX Stent is a self-expanding, small metal, mesh tube with the outer surface coated with the drug Paclitaxel that is implanted in an artery of the thigh. The stent provides a scaffolding to hold the artery open while the Paclitaxel coating helps prevents the artery from narrowing again.
The problems with the Zilver PTX stent are related to the delivery system. To implant the stent, a surgeon makes a small incision in a patient’s groin area, then inserts a long tube known as a catheter into the patient’s femoral artery. An inner catheter then deploys the Zilver PTX stent into the artery. Unfortunately, the tip of this inner catheter has become separated in at least 13 patients, causing serious injury to at least two patients and one death in the first month after the device was approved by the FDA.
Injuries that may be suffered when the delivery system for the Zilver PTX stent fails include:
- Emergency surgical removal of the catheter tip
- Blood vessel obstruction
- Blood clots
- Cardiac arrest
- Lacerated blood vessels
- Amputation of the leg
- Permanent disability
The Zilver PTX stent was recalled by Cook Medical in April 2013, but not before multiple patients were injured and one patient died due to improper manufacturing of the delivery system for this stent.
Can I file a lawsuit if I have have been injured by the Zilver PTX Stent?
Possibly. If a manufacturer produces a dangerous or defective product, it can be held responsible to those who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has been harmed by the Zilver PTX Stent, you should contact your doctor immediately. You may also wish to contact an experienced Zilver PTX Stent lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.