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Heart Device Linked to Deaths

October 30, 2003|From Associated Press

WASHINGTON — More than 60 patients who received a popular new drug-coated heart stent have died, the government disclosed Wednesday, a surprising increase since the last health warning about the device just months ago.

The Cypher stent is a tiny metal scaffold used in patients with heart disease. It props open a cleaned-out artery and, unlike other stents, emits a drug to reduce the chances the artery will clog again. But that drug doesn't prevent a different risk posed by all stents: blood clots that form around the device and can cause a heart attack.

Cypher stents began selling in April, and in July the Food and Drug Administration warned that it already had received reports of those blood clots in 34 Cypher recipients, including five who died.

Wednesday, the FDA issued a second warning: It now has counted more than 290 reports of blood clots in Cypher recipients, and in more than 60 the device was associated with the patient's death. Those clots occurred up to 30 days after the stent was implanted.

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