Heart Stents

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Heart Stent Procedure

In April 2003, Cordis Corporation received approval for the Cypher heart stent, unlike other stents because it emits a drug to reduce chances of the artery re-clogging. The heart stent procedure props open a cleaned out artery. This latest type of heart stent procedure was believed to be an improvement from the previously bare metal stents, but this heart stent procedure requires an anti-clotting drug be taken for three months after the heart stent procedure versus the usual two-week prescription.

Within a day to 30 days of the heart stent procedure, the FDA began to receive reports that blood clots were occurring. In July 2003, the agency released its first warning about the heart stent procedure after receiving reports of 34 instances of blood clots, including 5 deaths. There appeared to be minimal alarm in response to the heart stent procedure warning, but then in October 2003, the FDA issued its second heart stent procedure warning just months after its first.

A shocking increase of heart stent procedure adverse events had been reported between July and October. The drug agency as of October 20, 2003 received reports that more than 290 patients suffered blood clots after their heart stent procedure, including over 60 deaths. There were also more than 50 reports of allergic-type reactions to the heart stent procedure, including an undisclosed number of deaths. Right now, Cordis Corporation is conduction a 2,000 patient study on its heart stent procedure device to track rare side effects, as well as other aspects.

Product Liability Breaking News

"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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