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product_liability heart_stentSub-acute thrombosis (SAT) is considered a more rare adverse event associated to the implantation of stents. A stent is a permanent device used to prop open a cleaned out artery. In April 2003, Johnson & Johnson''s Cypher stent was the first approved drug-coated stent. Although sub-acute thrombosis (SAT) can occur with any type of stent, after the Cypher stent entered the market, reports of SAT led the agency to issue two warnings about the adverse events.
Within three months of its approval, over 50,000 of the Cypher stents were used in patients. What the FDA was not expecting was to receive as many reports of sub-acute thrombosis (SAT) as it did. By July 2003, three months after sales for the Cypher stent began, the agency had received reports of sub-acute thrombosis (SAT) in 34 Cypher recipients, including five deaths. More alarming, was the second FDA warning issued in October 2003 after reports of over 290 sub-acute thrombosis (SAT) and over 60 associated deaths were counted.
The reports of sub-acute thrombosis (SAT) were made through the FDA''s Medical Device Reporting system, which is estimated to receive just a small fraction of actual adverse events suffered. In November 2003, the FDA updated patient and physician information regarding the use of Cypher stents and sub-acute thrombosis (SAT), finding the device to be a safe and effective product when used according to the labeling.
The drug agency considered the rate of sub-acute thrombosis (SAT) occurrences to be within the expected rate for any stent, despite its initial position that an unexpected number of reports had been made. It was noted that sub-acute thrombosis (SAT) risk would be reduced when using the appropriate size Cypher stent, as well as implementing aggressive antiplatelet drug therapy.
Over 2,000 patients every year are suffering avoidable injury and death as a result of stents, small metal devices used to hold open heart arteries, according to two doctors who wrote an editorial published in a leading medical journal.
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Despite reports of more injuries related to Boston Scientific Corp.’s heart stents, the FDA said they did not plan on taking any further action against the company. Last year, Boston Scientific recalled more than 99,000 Taxus heart stents following re...