FDA investigates longitudinal failure of ION Coronary Stent (Boston Scientific)

According to a case report in the Journal of Interventional Cardiology, a patient experienced a heart attack after the recently marketed ION Coronary Stent (called the Taxus platinum in Europe), from Boston Scientific, in his artery shortened and accordioned. The ION Coronary Stent was approved by the FDA earlier this year. According to Cindy Grines, of the Detroit Medical Center Cardiovascular Institute, a particular class of stents are susceptible to becoming deformed, which could result in adverse clinical consequences. This shortening usually occurred when the clinician attempted to complete the procedure with the typical catheters and balloons used after a stent is implanted. Stent shortening and deformity can cause serious complications for patients; in this case the stent clotted off and the patient had a heart attack. The FDA is now working with stent manufacturers, including Boston Scientific, to understand this longitudinal deformation. See: "Deformation, Longitudinal Shortening, and Accordion of an Ion Stent" Antwon Robinson et al, Journal of Interventional Cardiology, first published online: 11 NOV 2011 (DOI: 10.1111/j.1540-8183.2011.00699.x)