Boston Scientific Medical Devices

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Coronary Stent

June 2011
FDA ANNOUNCES URGENT RECALL OF FAULTY STENTS
The Food and Drug Administration has announced an urgent recall by Boston Scientific Innova of its self-expanding stent system because of failures to deploy.

The agency noted that complaints of no deployment and partial deployment have been received. This type of failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent. This recall does not affect stents that have already been implanted as the issue occurs during delivery of the stent.

The FDA said the Innova Stent System is intended for use in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery. The agency said Boston Scientific sent an urgent medical device recall letter to OUS customers on May 13, 2011. The recall notice explained the issue, identified the affected products, required distributors to cease further distribution and use of the product, and requested the return of unused product to Boston Scientific.

The U.S. Food and Drug Administration (FDA) issued a July 1, 2004 Class 1 recall regarding the Boston Scientific Coronary Stent (also known as the Boston Scientific Taxus™ Express2™ Coronary Stent.) These defective heart stent devices were allegedly linked to a number of serious health conditions such as:

  • Drug Coated Stent-related deep vein thrombosis

  • Drug Coated Stent-related heart attack

  • Drug Coated Stent-related stroke

  • Drug Coated Stent-related pulmonary embolism

  • Drug Coated Stent-related blood clots

  • Drug Coated Stent-related death

An FDA Class 1 recall is the most serious of all FDA-related recalls, as it represents a product that is likely to cause serious injury or death in consumers. Thus, it is more likely than many recalls to be picked up by the media and make headlines.

The Boston Scientific Coronary Stent was used during surgery of coronary artery patients. However, the Boston Scientific Coronary Stents with lot numbers 6294706 and 6365192 were found to have defects, specifically that the balloon inserted with the Boston Scientific Coronary Stent failed to deflate and therefore could not be removed after the stent was put into place. The drug-coated stent warnings were not available until studies revealed the dangers of heart stent malfunction and drug coated defective heart stents

If such a balloon is not able deflate, the result could mean emergency coronary artery bypass graft surgery or death; thus, the malfunctioning of the Boston Scientific Coronary Stent could cause a stent deep vein thrombosis which can easily be fatal or life-altering. The Minneapolis-based Boston Scientific Corporation that manufactured the Boston Scientific Coronary Stent went along with the FDA's warning and recall.

However, with any product recall, there is a chance that consumers may still be affected by the defective item.

If you or someone you love received surgery during which the Boston Scientific Coronary Stent was used and then suffered a medical consequence, we want to hear your story. It might surprise you to learn that your adverse side effects could be traced back to the Boston Scientific Coronary Stent. If that's the case, you might have a claim against Boston Scientific.

Flextome

Angioplasty is a procedure to open up partially blocked arteries, usually in the heart. In this procedure, a small catheter is inserted through the skin and threaded up into the arteries around the heart. They use fluoroscopy to watch where the catheter is going. When the doctor gets the catheter in the right place, he gently inflates a small balloon on it, which crushes fatty deposits against the artery wall. This opens up the artery and allows better blood flow to the heart.

Sometimes the fatty deposits are hard and fibrous, and won't crush easily. If the doctor uses too much pressure, she could rupture the artery. The Boston Scientific Flextome Cutting Balloon System was invented for these situations.

The Boston Scientific Flextome Cutting Balloon System is similar to a regular angioplasty balloon, except that the balloon has tiny microsurgical blades on the outside of it. As it is inflated, it scores and cuts the fatty deposit, so that it can be crushed without using too much pressure.

The Problem with Boston Scientific Flextome Cutting Balloon Systems

After the procedure, when the catheter is being removed, the shaft of the Boston Scientific Flextome Cutting Balloon System can separate, making it difficult to remove the catheter. It may take a longer, more complicated, riskier procedure, or even surgery to remove it.

Before the Boston Scientific Flextome Cutting Balloon System was recalled, this problem was reported eight times. Three people needed surgery to remove the catheter.

Patient Problems related to the Boston Scientific Flextome Cutting Balloon System

All of the problems associated with Boston Scientific Flextome Cutting Balloon Systems occurred during the procedure, so there are no new problems for those who have already had the procedure.

The problem with the balloon has been corrected, so people who have an angioplasty with a similar device in the future aren't affected.

During the procedure, people who were victims of this problem would have had either a longer and riskier procedure, or they may have had to have unexpected surgery to remove the separated part of the catheter.

People who needed a riskier procedure may have received routine medication for the procedure that causes them not to remember what happened. They would also have an increased risk of infection, the possibility of heart rhythm problems and the potential for more serious problems.

Those who had surgery were at risk for having the catheter block the artery or rupture the artery. Either of those events could cause a heart attack.

The Boston Scientific Flextome Cutting Balloon System was recalled worldwide in December 2005. If you had an angioplasty with a cutting balloon before that, and think you may have experienced complications because of this defect, you may be entitled to financial compensation. Call our personal injury lawyers today.

Hemashield VANTAGE Vascular Grafts

On June 27, 2005, the U.S. Food and Drug Administration (FDA) issued a Class 1 Recall regarding the Boston Scientific Hemashield® VANTAGE™ Vascular Graft, manufactured by Boston Scientific Corporation of Boston, Massachusetts.

A class 1 recall is described by the FDA as "the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death." (www.fda.gov)

The Boston Scientific Hemashield® VANTAGE™ Vascular Grafts were used during surgery as a result of peripheral vascular disease. Though they were meant to help bypass arteries, the Boston Scientific Hemashield® VANTAGE™ Vascular Grafts were discovered to fray and tear at the suture line. This serious malefaction could easily lead to postoperative concerns that could wind up being fatal.

Boston Scientific sent out a follow-up press release on June 27, 2005 announcing its voluntary recall of the Boston Scientific Hemashield® VANTAGE™ Vascular Grafts. In the release, the company noted that there had been "three reported post-operative failures". Thus, Boston Scientific recalled all Boston Scientific Hemashield® VANTAGE™ Vascular Grafts on the market.

Boston Scientific and the FDA encouraged those who had been implanted with Boston Scientific Hemashield® VANTAGE™ Vascular Grafts and had not suffered any adverse reactions to keep the Boston Scientific Hemashield® VANTAGE™ Vascular Grafts inside their bodies. However, Boston Scientific did suggest that if patients with Boston Scientific Hemashield® VANTAGE™ Vascular Grafts started to feel pain, see swelling or bruising, or experience rapid pulse or low blood pressure, they should contact a physician immediately.

If you or someone you love was fitted with a Boston Scientific Hemashield® VANTAGE™ Vascular Graft during surgery for complications due to peripheral vascular disease and had an adverse reaction to the graft or had the graft malfunction during your medical procedure, please contact our law offices today. As consumer advocacy attorneys, we are gravely concerned that defective devices such as the Boston Scientific Hemashield® VANTAGE™ Vascular Grafts may still affect hundreds of patients.

Vena Cava Filters

At the end of 2005, the U.S. Food and Drug Administration (FDA) issued a very stern Class 1 Recall of the Boston Scientific Vena Cava Filters (also known as the Boston Scientific Stainless Steel Greenfield® Vena Cava Filters). The FDA recall caused many in the media to take notice, as a Class 1 is issued only if there is a "reasonable probability" that use of the product could result in severe injury or death.

The Boston Scientific Vena Cava Filters were used to help prevent pulmonary embolisms in patients by being implanted in the inferior vena cava. As the vena cava (vein) carried blood, the blood was filtered by the Boston Scientific Vena Cava Filters. Ideally, the Boston Scientific Vena Cava Filters were expected to "catch" any potential blood clots, thereby saving the lives of those with the devices.

However, the Boston Scientific Vena Cava Filters with product code M001505010 (manufactured before March 10, 2004), were plagued with problems. Detachments of the product during the implant procedure were reported, and Minnesota-based Boston Scientific Corporation consequently sent out a press release voluntarily removing the Vena Cava Filter from the market.

In the Boston Scientific Vena Cava Filters' letter to the public, Boston Scientific officials noted that 18,000 Vena Cava Filters had been sold to hospitals worldwide, but that those Boston Scientific Vena Cava Filters which were safely implanted in patients need not be removed.

The FDA echoed Boston Scientific's safety concerns and suggested all customers return unused Boston Scientific Vena Cava Filters to the manufacturer by March 2007.

To date, there have been a number of reported cases and concerns related to the Boston Scientific Vena Cava Filters; however, with so many patients walking around with Boston Scientific Vena Cava Filters inside their bodies, we can expect more persons to come forward. After all, if the product has shown one defect, chances are it may have others.

The fact that any Boston Scientific Vena Cava Filters are still in use troubles us. At our law firm, we are devoted to the protection of consumers from defective medical devices. If you or someone you love has a negative experience with Boston Scientific Vena Cava Filters, we'd like to hear your story. We may be able to get you financial compensation for your pain and suffering. Contact us today.

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If you've been injured from a Boston Scientific Coronary Stent, Flextome, Hemashield VANTAGE Vascular Grafts, or Vena Cava Filters we can help you find a lawyer in your area. Updated 3/06/2013