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Covidien Brain Device Tied to Nine Deaths, U.S. FDA Says

Covidien Plc’s Onyx system used to block blood flow in abnormally formed vessels in the brain has been linked to nine deaths, U.S. regulators said.

The Food and Drug Administration received more than 100 reports since 2005 about breakage related to a catheter used to help the Onyx liquid material obstruct the blood vessels before they are surgically removed, the agency said today in an alert on its website. In at least 54 cases, the catheter and some of the liquid material remained implanted because the device couldn’t be removed, the FDA said.

Covidien, based in County Dublin, Ireland, updated the labeling of the Onyx Liquid Embolic System to warn about the risks related to catheter entrapment. The FDA approved the labeling changes in April, the agency said. If the catheter can’t be removed, surgeons still probably will be able to take out the abnormally formed blood vessels, according to the FDA. The agency warned that complications from long-term implantation of the catheter and the liquid material can be serious.

“The most serious complications include hemorrhage and death,” FDA said. “Other complications include migration of the Onyx plug or catheter fragment to other parts of the body.”

Patients who experience catheter entrapment may need to take antithrombotic drugs to reduce the risk of blood clots, the agency recommended.

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