Coronary Stent Implant Malpractice

For people with coronary heart disease, coronary stents are a common surgical treatment to open the arteries and keep blood flowing to the heart. The treatment can be a lifesaver to help patients with angina and reduce the risk of an acute myocardial infarction or heart attack.  When talking about angioplasty and coronary stent surgery, people facing the procedure may be surprised to find out how common it is. However, just because it is common does not mean it is not without risks. In some cases, the surgery may not be entirely necessary. In the worst-case scenario, negligent coronary stent implant procedures can cause serious injuries or death.  If a loved one suffered complications or died after negligent coronary stent surgery, it may have been caused by medical malpractice. Contact an experienced medical malpractice lawyer for legal advice about your coronary stent implant case. 

What Is a Coronary Stent?

A coronary stent is a hollow device that is surgically implanted in the coronary arteries to keep the arteries open. The tube-shaped metal mesh device helps clear the path to supply blood to the heart for patients with coronary heart disease. Coronary stent implants are used in a majority of angioplasty or percutaneous coronary intervention (PCI) procedures. Angioplasty or PCI refers to medical procedures that are used to open blocked coronary arteries.  There are risks associated with coronary stent surgery, including scar tissue blockage, bleeding with anti-clotting medication, blood clots, and other complications. In some cases, coronary stent implants may not be the best treatment option when there are so many other less invasive options.  Thousands of patients may be undergoing unnecessary coronary stent surgery just so the doctor can make more money for the expensive procedures. According to a study published in the Journal of the American Medical Association (JAMA), only about half of nonemergency angioplasty procedures were appropriate.  According to a report by ProPublica, Medicare spent almost $1 billion on angioplasty procedures, paying doctors to do possibly unnecessary procedures at the taxpayers' expense. Aside from the unnecessary cost, about 3% of patients experience serious complications, which is unacceptable for unnecessary medical procedures. 

Coronary Heart Disease

In coronary artery disease, cholesterol deposits build up in the heart arteries. Over time, as the buildup grows, the flow of blood to the heart is reduced, which can cause chest pain, fatigue, or shortness of breath. If the artery is completely blocked, it can lead to a heart attack. Risk factors for coronary heart disease include:

• Smoking
• High blood pressure
• High cholesterol
• Diabetes
• Obesity
• Family history of heart disease

Doctors generally diagnose coronary heart disease based on scans, blood tests, or imaging. A blood test can show the levels of cholesterol, proteins, triglycerides, amino acids, and other indicators of a risk of heart disease. Tests can show heart function and blood flow, including:

• Electrocardiogram (ECG or EKG)
• Echocardiogram
• Stress ECG
• CT scan 
• Cardiac catheterization 

Some non-surgical ways to treat coronary heart disease include exercise, healthy eating, stopping smoking, and medications. Cholesterol drugs and blood pressure medications are common and aspirin is a common over-the-counter medication prescribed to some patients.  The most common surgical procedures are coronary artery stent implants and coronary bypass surgery. 

Coronary Stent Implant Surgery

In coronary angioplasty, a coronary stent is implanted surgically. The doctor will insert a catheter into the artery where there is a blockage. A surgeon may use contrast dyes in fluoroscopy to provide a visual image of the blockage and arteries in surgery, to properly locate the blockage and place the stent. A balloon attached to the tip of the catheter is inflated, which widens the blockage area to make way for the mesh stent. The mesh stent is implanted to maintain a clear path for blood flow to the heart.  Over time, from a few months to a year, the body will line the mesh of the stent with tissue. In some PCI procedures, the stent is treated with medicine that can help maintain clear arteries. These are known as drug-eluting stents (DES). The medicine reduces scar tissue building over the stents, which can cause a narrowing of the arteries.  Stents are not always a perfect treatment. Stents can become blocked over time. If too much scar tissue builds up, patients may require repeat angioplasty or additional stent placement. Radiation therapy is another possible treatment for scar tissue build-up. Patients may still have to take medication to reduce platelet buildup.  There are some doubts in the medical community over the long-term effectiveness of coronary stent implants. It does relieve chest pain or angina in some patients but its long-term effects are less clear. Many heart attacks are not caused by the narrowing of the arteries but instead when buildup breaks loose, causing a clot to reduce blood flow.  After the procedure, the patient generally recovers in the hospital for observation for several hours. The medical team will monitor vital signs and watch for possible complications, including numbness, chest pain, or bleeding. Most patients will need to stay the night in the hospital for observation but are often released the next day to go home with aftercare instructions.

What Are the Risks of Coronary Stent Implants?

Like any surgery, there are risks of angioplasty and coronary stent implant. Some of the possible risks of coronary stent implants include:

• Anesthesia risks
• Excessive bleeding at the catheter insertion site
• Blood clots
• Infection at the catheter insertion site
• Heart attack
• Coronary artery rupture
• Coronary artery closure
• Contrast dye anaphylaxis 
• Kidney damage
• Stroke
• Chest pain

Some procedures may produce uneven or poor results. The surgeon may suggest revision surgery. However, revision surgery includes additional risks.  Coronary stent implant malpractice means that the doctor, surgeon, or other health care provider was professionally negligent in your care. Malpractice occurs when a doctor deviates from the standard of medical care which causes your injury and harm. If you aren't a doctor, you may not know when a medical professional is doing something other doctors would not do. This is when you may need to turn to a medical malpractice attorney who understands these types of injury cases. 

Did You Give Informed Consent for Surgery?

As part of the preparation for angioplasty and coronary stent implant surgery, doctors are supposed to get the patient's informed consent. Informed consent means that the patient understands the risks and benefits of the procedure and approves the choice to get surgery. If the patient doesn't know the risks and benefits, they can't make an informed decision. Meaningful informed consent requires understanding: 

• Risks of the procedure
• Benefits of treatment
• Side effects
• Possible complications
• Reasonable alternatives

According to Johns Hopkins Medicine, based in Baltimore, Maryland, as part of preparing for an angioplasty, "You will be asked to sign a consent form that gives your permission to do the procedure. Read the form carefully and ask questions if anything is unclear." This includes understanding:

• Name of the procedure
• Reasons for the procedure
• Expected results
• Risks and benefits 
• Possible side effects and complications
• When and where you are to have the procedure
• Who will perform the procedure and their qualifications
• What would happen if you didn't get the procedure
• Alternative procedures 
• When you will get the results
• Who to contact after if you have questions or problems

This makes the process sound clear and straightforward. Unfortunately, it is not always so cut and dried. Patients may be given their informed consent form when they are waiting for surgery. This really doesn't give the patient any time to fully review the form and think it over. They are often pressed to return the signed form quickly before going in for surgery.  A study by the Joint Commission looked at some of the common problems with informed consent, indicating many healthcare providers treat it more like just getting a signature. Common barriers to understanding consent forms included: 

• A lack of basic information on the consent form
• Ineffective provider-patient communication
• Lack of shared decision-making between patient and provider
• Lack of consideration of the health literacy of patients
• Lack of consideration of cultural issues

According to a report in the Annals of Internal Medicine, most authorities agree that the active involvement of patients in medical decision-making has not happened. With such a divide between doctors and patients, barriers to informed consent include:

• Treatment decisions take place over a long period
• There are multiple decisions to be made
• Patients believe the decisions are made by the doctor
• Physicians don't understand patient reasoning
• Medical decision-making involves so many people that the patient does not know who is responsible

If a patient doesn't have the time, health literacy, or the basic information is not even provided on the consent form, how can the patient give informed consent? If the patient suffers a side-effect, complication, or risk of surgery that they were never told about, they may have a medical malpractice informed consent claim for damages. 

Coronary Stent Device Defects

One of the problems with coronary stent surgery involves the use of defective medical devices. Coronary stents are supposed to be designed to appropriately help patients maintain blood flow and normal coronary function. Stents are also supposed to be manufactured safely, under sanitary conditions, and meet quality control standards. Unfortunately, many patients have found out too late that the coronary stents used in their surgery were defective.  If a patient is injured because of a dangerous or defective stent, they may be able to recover compensation from the manufacturer of the device. The injury victim doesn't even have to claim the manufacturer was negligent, only that the device was defective when it was produced and the defect was responsible for the patient's injuries. 

Coronary Stent Recalls

When patients have problems related to a medical device, it can cause a safety alert notice from the Food and Drug Administration (FDA). If there are concerns about the safety of the device from serious complications or too many safety alerts, the manufacturer may issue a voluntary recall. If the manufacturer doesn't want to recall the device, the FDA can require a mandatory recall.  Recalls are classified based on the level of danger. Class I is a severe hazard, Class II is for moderate hazards, and Class III is for mild hazards.  For example, Boston Scientific recalled more than 31,000 venous stent systems distributed from September 21, 2018, to April 9, 2021. The Class I recall came "after reports indicate that the stents may migrate or move from where they are initially implanted." In 2022, Atrium Medical Corporation recalled more than 68,000 stents because of the potential balloon or catheter hub separation. The devices were distributed between December 31, 2018, and March 31, 2022. According to the Class I recall, "Depending on the location of failure, occlusion may lead to amputation, embolism, loss of organ function, organ infarction, and tissue infarction." According to an article published in the journal Public Library of Science (PLOS), there have been more than 100 recall reports for cardiac implants, including stents. Most of the recalls involved implantable cardioverter defibrillators, followed by pacemakers. Almost 15% of the recalls were for coronary stents.  In a report published in the Journal of Invasive Cardiology, researchers looked at the number and rate of stent recalls. Between 2002 and 2013, there were 17 coronary stent recalls involving about 500,000 devices. The most common reasons for the stent recalls were:

• Sterility (29%)
• Wrong labeling or wrong packaging (24%)
• Impaired stent delivery (18%)

Can I Get Compensation for Coronary Surgery Malpractice?

If you were injured because of an unnecessary coronary stent surgery, you may be able to recover financial compensation from the doctor. If a loved one died after complications from a coronary stent implant procedure, you and your family may be able to file a wrongful death claim for damages.  Damages in a medical malpractice claim can include medical bills, loss of income, additional medical treatment, pain and suffering, and emotional distress. In a wrongful death claim, the estate or family members can recover money for funeral expenses, burial costs, and loss of support. If you're not sure if the injuries were caused by professional negligence or a defective medical device, talk to a medical malpractice attorney about your claim. Experienced medical malpractice lawyers, like the trial attorneys at Gilman & Bedigian, have extensive experience in heart surgery malpractice because they focus on just these types of cases. With the right legal team on your side, you will have the resources to help you recover damages after suffering a coronary stent injury. Contact Gilman & Bedigian online or at 800-529-6162 for a free consultation.