Cook Medical Inc. has announced a recall of the Zilver PTX stent, which is used to prop open arteries in the thigh of patients with circulation problems. The recall was initiated after 13 reports of the stent catheter tip separating in a patient’s body, which caused two injuries and one death.
UPDATE: Cook Stent Recall Issued for Zilver PTX Implant
On April 24, 2013, Cook Medical Inc. announced a voluntary nationwide/global recall of the Zilver PTX Drug-Eluting Peripheral Stent with the following notice:
“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.”
What Cook Stent was Recalled?
The Cook stent recall involves the following product: Zilver PTX Drug-Eluting Peripheral Stent, which was approved by the FDA in November 2012.
The Zilver PTX stent is a permanent medical implant that is used to prop open a patient’s femoropopliteal artery, which is a major blood vessel located in the thigh. This artery becomes narrowed and blood-flow is reduced to the lower leg in patients with a circulatory problem called peripheral artery disease (PAD).
The stent is a small, self-expanding device made of metal mesh in a tube-shape. It is coated with a drug called Paclitaxel to help keep the artery open. This helps improve circulation to the lower leg.
Cook Stent Recall Information
There is no risk of injury for patients who have already been implanted with the recalled Cook stent. This is because the defect only involves the catheter stent delivery system and not the stent itself. Patients may have been implanted with the stent from December 2012 until the recall in April 2012.
When a patient is being implanted with a stent, a doctor makes an incision in their groin to access the femoral artery. Then, a long and flexible tube called a catheter is inserted through the incision and guided into appropriate location. Then, an inner catheter deploys the stent into the patient’s thigh.
Cook found the defect with a component of the inner catheter and delivery system for the stent, and warned:
“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
Cook Medical has received 13 reports of the catheter tip separating, with potentially deadly results. At least two people have been injured and one person has died from this complication. Injuries associated with a defective stent include:
- Additional surgery to remove detached catheter tip
- Failure of surgery to remove the catheter tip
- Catheter tip may obstruct blood vessels
- Blood clots (thrombosis)
- Blood vessel laceration
- Embolization of catheter tip
- Decreased circulation in the leg
- Cardiac arrest