Medical Devices Recall
In addition to the latest recall by Boston Scientific on August 5th, the company has previously recalled its stents before. On July 2, 2004, they recalled 200 of their Taxus Express 2 Coronary Stent Systems because of malfunctions in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure. Problems occur when the tiny balloon used to expand the stent inside the clogged heart arteries fails to deflate after it has been used.
In the taxus stent, there is a narrowing in the area where the catheter and balloon have been laser-welded resulting in impeded deflation.
Since Boston Scientific's Taxus stent FDA approval in March 2004, more than 222,000 stents have been implanted at more than 1,300 hospitals in the United States and over 220,000 have been implanted in other countries.
If you experienced problems after receiving a Taxus Stent, it is important that you contact a qualified, experienced law firm that is already reviewing and accepting cases dealing with artery stents, coronary stents, heart stents, and Taxus stents.
Defective Stents Lawyer
On August 5, 2004, Boston Scientific Corporation announced the third in a series of recalls of its Taxus Stents, which are drug-coated wire mesh devices placed in the arteries of patients whose arteries have become blocked by deposits of fat.
If you or a family member sustained serious injury or even death during the surgical implantation of this stent you may be entitled to file a claim against the manufacturer for money damages.
Tens of thousands of stents have now been recalled since early July of 2004. Not long after these devices began to be sold in the United States, Boston Scientific began to receive complaints that tiny balloons that are used to expand the artery for placement of the stent were not properly deflating during the operation. This can result in a fairly straightforward procedure becoming deadly to the patient, or resulting in serious physical injury. The Boston Globe has reported that this potential manufacturing defect has so far been linked to three deaths and 47 serious injuries.
Patients who have already received implanted stents of this type through a successful operation are not affected by the recall because the problem arises only during the surgery during which the stent is implanted.
Initially, Boston Scientific attributed the problem to the insertion techniques of doctors, however, they discovered a problem with the delivery system itself and recalled 200 stents. After the defective stent recall, Boston Scientific expanded the stent recall to over 80,000 stents possibly affected by the problem.
Meanwhile, several cardiologists and hospitals have suspended use of the Taxus stent but as mentioned earlier there is no reason to be concerned if you already have received a Taxus stent. The problem here has been with the placement of the stent, not with the stent itself. Once successfully deployed, the Taxus stent functions as designed.
Stenting is a catheter-based procedure in which a small, expandable wire mesh tube (stent) is inserted into a diseased artery, serving as a scaffold to hold it open. Stents are placed within a coronary artery plaque and then are expanded against the plaque by blowing up a balloon. Once the stent has been expanded in order to compress the plaque and hold it into place, the balloon is then deflated and the catheter is removed. In some patients receiving the Taxus stent, doctors have been unable to deflate the balloon after expanding the stent resulting in these patients requiring emergency bypass surgery.
As with any medical procedure there are potential risks with the Taxus stent. To read more about the potential risks associated with stents, Taxus Stents, Artery Stents, Coronary Stents, and Heart Stents click here.
The Rasansky Law Firm has extensive experience in representing victims of defective products, medical malpractice, and other personal injuries. We are now currently reviewing and accepting cases involving stents, specifically the Taxus Stent. Contact us immediately via our online form or call us toll free at 1.800.704.3578.
Taxus Stent Risks
Malfunctions in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure. Problems occur when the tiny balloon used to expand the stent inside the clogged heart arteries fails to deflate after it has been used.
Vessel damage can occur when the Taxus stent is implanted and can sometimes cause a tear or even dissection of the artery.
Another complication of stent placement is subacute thrombosis in which platelets aggregate and form a blood clot within the stent, potentially causing closing of the stent and a heart attack.
Approximately 20 percent of stents re-narrow or restenose within six months of placement. The risk of restenosis is greater in patients who undergo balloon angioplasty alone without stenting. This is especially true in those who have undergone balloon angioplasty, which can provoke a build-up of cells in the artery.
Risk of restenosis can be associated with C-reactive protein (CRP). CRP is a substance that the body releases in response to inflammation. High levels of CRP in the blood mean that there is inflammation somewhere in the body. CRP is the only inflammatory marker that has been found to be an indicator of heart health.
The Rasansky Law Firm has extensive experience in representing victims of defective products, medical malpractice, and other personal injuries. We are now currently reviewing and accepting cases involving stents, specifically the Taxus Stent. Contact us immediately via our online form or call us toll free at 1.800.ATTORNEY.