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Johnson and Johnson’s subsidiary Cordis Corporation received approval for its heart stent April 24, 2003. Shortly after, the FDA’s Medical Device Reporting (MDR) system began to receive adverse event reports in association to the use of the heart stent. Approved to prevent clogged coronary arteries amongst patients undergoing angioplasty procedures, the heart stent caused serious enough concern to lead the FDA to issue its first advisory in July 2003.

Informing health care professionals of the “rare but potential risk of thrombosis,” or blood clotting, linked to the use of the Cypher heart stent in July 2003, the agency believed further review was appropriate to determine the exact causes and to reduce the risk of thrombosis among Cypher heart stent users. The FDA, in response to the possible link between the heart stent and blood clots, required Cordis to commence post- approval studies. The heart stent studies were to help the FDA track heart stent adverse effects more accurately in addition to more specifically determining if the blood clotting in heart stent patients was occurring at a different rate than in pre-approval studies.

Then in October 2003, the FDA issued yet another warning about the heart stent. The agency informed physicians about Cypher heart stent adverse events on October 29, 2003, prompting a high number of concern and question among patients. The heart stent warning was issued after already more than 450,000 heart stent units were distributed worldwide, as of October 10, 2003.

According to the FDA heart stent notification, numerous reports of adverse events have been reported through the MDR system, which excludes a significant amount of underreporting thought to have occurred. By October 20, 2003, the FDA had received over 290 reports of blood clotting associated to the use of the heart stent, with over 60 of the heart stent reports resulting in death and the remainder requiring medical or surgical intervention. The heart stent adverse events were reported to occur one to 30 days after the procedure was performed.

The agency did note that analysis was still underway and the heart stent adverse event etiology had not yet been determined. Cypher heart stents are coated with a thin polymer containing the drug sirolimus, which was considered a medical improvement from the previous bare metal stent by reducing the rate of artery re-blockage according to studies. Immediately after the FDA heart stent announcement in October, concern was evident at the American Heart Association’s annual meeting. A past AHA president classified the FDA heart stent announcement as a “red flag”.

In addition, the FDA has received more than 50 reports of allergic-type reactions among heart stent patients. Leading cardiologists and drug company officials are stressing the importance of proper heart stent implantation procedures. Heart stent patients are encouraged to continue their follow-up appointments and to closely monitor any symptoms that could be a warning sign of suffering potentially deadly heart stent adverse events.

The FDA may not have all the information regarding heart stent safety until March 2003, according to some estimates.

If you are experiencing difficulties with your heart stent, contact our expert product liability lawyers for a free case review.

"Serious Danger from Drug-Coated Stents"

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.

The ar...

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"FDA will take no further action against Boston Scientific Corp.’s heart stents"

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...

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CBS News - Heart stent Warning

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