FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Heart Valve Delivery System Causes 19 Deaths

Aug. 19, 2016

Ireland-based Medtronic’s EnVeo R replacement heart valve delivery catheter has caused 19 deaths and 20 other vascular trauma events. This has prompted that company to warn doctors not to “force passage” if the catheter meets resistance.

“The EnVeo R system has been installed in 24,000 people worldwide,” the Minneapolis/ St. Paul Business Journal reported, “with about 7,300 used in the United States”.

The device is approved in the U.S. for patients who are at high risk for complications from traditional heart surgery.

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