Cook Medical Inc. has recalled a stent implant that is used to hold open arteries in the thigh of patients with peripheral artery disease. The Cook stent recall was initiated after the company received 13 reports of a defective catheter tip breaking during the implantation procedure, which caused two injuries, including one death. The company warned about injuries including additional surgery, blocked blood vessels, blood clots, amputation, and cardiac arrest.
Need a Texas Cook Stent Recall Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by a recalled Cook stent, you should contact our lawyers immediately. You may be entitled to compensation by filing a Cook stent recall lawsuit in Texas.
UPDATE: Cook Stent Recall Issued for Zilver PTX Implant
April 24, 2013 — Cook Medical Inc. initiated a voluntary global recall of the 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 Medical has initiated a nationwide/global voluntary recall of its Zilver® PTX® Drug Eluting Peripheral Stent. 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.”
Click here for the official Cook stent recall notice.
What Cook Stent was Recalled?
Cook Medical Inc. recalled the Zilver PTX Drug-Eluting Peripheral Stent, a medical device that is permanently implanted to hold open a patient’s femoropopliteal artery in the thigh to improve blood-flow to the leg.
The stent itself consists of a small, self-expanding, metal mesh tube (stent). The outer surface of the stent is coated in a drug called Paclitaxel, which helps keep the artery open. This Cook stent is designed to treat peripheral artery disease (PAD), a common circulatory problem that causes reduced blood-flow to the legs due to narrowed arteries in the thigh.
Cook Stent Recall Information
Patients who have already been implanted with a stent are not at risk of injury. The Cook stent recall was based on a problem with a catheter in the stent delivery system, and not the stent itself. The recalled stents were distributed from December 2012 until April 2013.
During the implantation procedure, a small incision is made in a patient’s groin. A long, narrow tube called a catheter is inserted through this incision to the appropriate location in the patient’s leg. The stent is deployed through the catheter and implanted in the patient’s thigh.
According to Cook, an investigation found evidence of the following defect:
“Internal component of the delivery system used to implant the stent did not consistently meet established design criteria.”
Injuries and Death Prompts Cook Stent Recall
The recalled Cook stent has been associated with 13 reports of catheter tip separation, two reports of injury, and one death. Potential injuries associated with a defective stent include:
- Severe pain
- Surgery to remove catheter tip
- Failure to remove catheter tip
- Blocked blood vessels due to detached catheter tip
- Blood clots (thrombosis)
- Laceration of blood vessels
- Embolization or migration of catheter tip
- Loss of circulation to the leg
- Cardiac arrest
- Permanent disability
Do I have a Cook Stent Recall Lawsuit in Texas?
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