Guidant MultiLink Vision Stent
Heart disease is the leading cause of death in the United States. Heart disease encompasses a number of different diseases and conditions, including congenital heart disease, high blood pressure, high cholesterol, and arrhythmia. A specific problem that many people with heart conditions experience is an irregular heartbeat.
In a human heart, the natural pacemaker is called the sinoatrial node, or sinus node. The sinus node is a small mass of specialized cells that is located on top of right atrium of the heart; its function is to make electrical impulses that make the heart beat. Occasionally, people will experience a heartbeat that is too fast, too slow, or irregular (called heart arrhythmias). Arrhythmias are fairly common and often harmless. However, they may also be an indication of a serious problem, such as a defect in the body's natural pacemaker or a blockage of the heart's electrical pathways.
Artificial pacemakers are used to help the heart beat in a regular rhythm and replace a natural pacemaker or blocked pathway. They send electrical impulses to the heart to help it pump. Artificial pacemakers are small, battery-operated devices that may be permanently implanted or may be temporarily placed on the exterior of the body. When an artificial pacemaker is implanted in the body, an electrode is placed next to the wall of the heart that sends electric impulses through a wire to the heart. Pacemakers can help alleviate symptoms of arrhythmias, including fatigue and fainting, and help people to resume more normal, active lifestyles.
There are a number of companies that produce pacemakers. The Guidant Corporation is one company that manufactures pacemakers. Guidant pacemakers are products that have single or dual chambers, which are able to treat both sides or one side of the heart. It is created to provide a mild current of electricity to regulate the beating of the patient's heart.
In 2005 the Guidant Corporation issued a voluntary warning to doctors that many of its older pacemaker models may have had issues and unexpected behaviors that could have potential adverse affects. The U.S. Food and Drug Administration (FDA) issued the warning as a Class I recall, meaning that the product defect could lead to serious or life-threatening injuries.
The safety information issued by the Guidant Corporation noted that a seal in the pacemakers, used in 78,000 pacemakers manufactured between 1997 and 2000, could leak, which would allow moisture to affect the electronic circuits within the devices. This problem could cause pacemakers to fail or to cause a rapid heart rate. The problems could arise without warning and the defect in the pacemaker may not be immediately detected; this could result in fainting, unconsciousness, possible heart failure, or death. Because removal of a pacemaker can pose a risk to a patient, the manufacturer recommended speaking with a doctor about the most appropriate course of action regarding his or her pacemaker.
If you or a loved one experienced serious injury as the result of the defect in a Guidant pacemaker, or if the defect resulted in death, it is highly recommended that you speak with an attorney who specializes in medical device defects and laws surrounding them. The defect present in this pacemaker may have caused you or your family physical pain, as well as added unforeseen medical expenses.
A lawyer can guide you through the legal process, assess your medical records and history, and determine whether or not you can make a claim. Lawyers will be able to help you seek compensation and peace of mind.
Heart disease is the leading cause of death of men and women in the United States. Heart disease can encompass a number of different conditions such as arrhythmia, high blood pressure, high cholesterol, or coronary artery disease. There are a number of different procedures, treatments, and products available to help improve the condition of heart disease and enable people with heart problems to live more normal, active lifestyles.
One particular product that was available on the market to help people with coronary heart disease, which is caused by a build-up of fatty substances such as cholesterol, was the Guidant corporation's Multi-Link Vision Stent. The build-up of fatty substances cause the artery to narrow and blood flow to slow. The Guidant Multi-Link Vision Stent is a tiny, metal, latticed tube made from cobalt chromium alloy that is slipped into an artery using a catheter with a balloon attached. The catheter is inserted into a blood vessel in the groin region and is threaded up to the affected artery. It is then moved across the area of blockage; the balloon is inflated, which causes the stent to expand and press against the artery wall. Upon deflation of the balloon and removal of the catheter and balloon, the stent remains permanently in the artery.
The coronary stent aids in propping open an artery that was surgically cleared so that regular blood flow through that artery can be restored and the symptoms of coronary artery disease are diminished. This type of stent has drugs associated with its use that lessen the chance of the arteries that were cleared and propped open getting blocked again.
It was recommended that the Multi-Link Vision Stent not be used if patients could not tolerate blood-thinning medicine or if they had a lesion that would prevent the completion of the inflation of a balloon for angioplasty.
On October 8, 2003, Guidant declared its intention to voluntarily recall certain manufacturing lots of its Multi-Link Vision Stent, specifically the ones that measured 3.0 mm in diameter. The coronary stents that were recalled did not pass regulation quality testing. They were also found to not to stay in place after insertion into an artery. The withdrawal of the products applied to stent shipments made to the United States, Australia and Europe. These stents were approved by the United States Food and Drug Administration (FDA) on July 16, 2003.
The possible defects of the Guidant Multi-Link Vision Stent could result in serious injury, or possibly death. In the event that you or a loved one was seriously injured as the result of a defective stent, or the insertion of a stent resulted in death, it is recommended that you speak with an attorney who is well-versed in defective medical products or wrongful death suits and laws surrounding them. An attorney will guide you through the legal process.
Each state has a statue of limitations regarding the time frame in which you can make a personal injury or wrongful death claim, typically between one and three years after injury was sustained. Thus, it is important to seek legal assistance relatively quickly in the event you believe you or someone you love has suffered from a serious injury.
At attorney who is well-versed in defective medical devices or personal injury will guide you through the legal process of making a claim. He or she will review medical records, speak with you about your experiences, and determine if you can make a viable claim. If you are able to move forward with the process, your lawyer will help you obtain compensation for damages, and potentially help you obtain some peace of mind.