Reportable based on device analysis completed on 16-apr-2018.It was reported that stent was defective.Vascular access was obtained via the femoral artery.The 80% stenosed, 2.75mm in diameter, concentric, de novo target lesion was located in the moderately tortuous and moderately calcified ostial left circumflex and proximal to mid left anterior descending artery.Pre-dilation was performed with a 2.75x15 balloon catheter leaving a 50% residual stenosis.With the support of a non-bsc guide extension catheter, a 2.75x38mm promus element ¿ long drug-eluting stent was advanced to treat the lesion.However, stent was defective as the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed proximal stent damage.
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