Device name: DES – Drug Eluting Stents (also known as medicated or drug-coated stents)
Manufacturer: Boston Scientific, Medtronic, Cordis
Approved uses: Prevention of artery closure and restenosis (artery reblocking) post-angioplasty
Side effects include thrombosis, necessity of long-term antiplatelet therapy to decrease thrombosis risk, and severe allergic reactions
DES – Drug Eluting Stents
Drug eluting stents (DES), also known as medicated or drug-coated stents, are small metal scaffold-like structures that are inserted into the coronary artery heart after balloon angioplasty in order to prevent artery closure. The stents are coated in medications that are intended to prevent restenosis (reblocking of the artery). Popular manufacturers include Boston Scientific, Cordis, and Medtronic. Stents are increasingly common, with market projections of up to $5 billion per year, they have been linked with side effects such as thrombosis, severe allergic reactions, and necessary long-term antiplatelet medication in order to prevent thrombosis. The drug-coated stents have also been linked to a higher death rate due to cardiac events such as heart attack when compared to metal stents without a drug coating.
Boston Scientific Recalls Heart Stent
NexStent Carotid Stent Recall
On August 14, 2008, the Food and Drug Administration announced that Boston Scientific has recalled NexStent Carotid Stents and Monorail Delivery Systems distributed from June of 2007 through May of 2008 in a class I recall. A Class I recall indicates a dangerous or defective product that is known to, or predicted to cause serious health problems or death. While Nextent customers were specifically informed of a problem with the device in June of 2008, the recall was not made public by the FDA until August of 2008. An unknown number of patients may have had a stenting procedure done with the NexStent Carotid Stent during that time.
What Is a Carotid Stent?
The NexStent Carotid Stent is a medical device is used in treating a blockage as a result of carotid artery disease. Used in a procedure called Carotid Artery Stenting (CAS), the stent is placed in the carotid artery to keep the artery open. In this procedure, the stent is placed into the neck via a delivery method call the Monorail Delivery System – which is also part of the recall. This Drug Eluting Stent (DES) was approved by the FDA in 2006. The recall is associated with any stents distributed by Boston Scientific after June of 2007.
Why Was the NexStent Recalled?
The product was recalled because the tip of the heart stent delivery system may detach during the implant procedure. This could cause injury to the artery, blood vessel damage, strokes and emergency surgery to remove the detached tip.
The recall does not affect Boston Scientific stents that have already been implanted. This is because the problem arises during the surgical procedure. If a stent has already been implanted successfully, the stent’s ability to work correctly is not affected.
Legal Help With a NexStent Carotid Stent Injury
If you or a loved one has been affected by the defective medical stent device, you should seek legal advice. Legalview is sponsored by a nationwide network of personal injury law firms. Fill out and submit a contact form below to be contacted by a DES lawyer.