No product or lot numbers were provided.The product was not returned.Information obtained from the physician that this was not a product failure, but an operative fault in selecting the incorrect size for the target lesion.Special care should be taken to ensure that the appropriate size devices are selected prior to introduction is stated in the instructions for use.Excessive stent length increases the chance of late loss down the road, and stenting too short means you miss the edge of the lesion and increase the patient's chances of repeat revascularization.An elective procedure should include an accurate measurement to put the right-sized stent in the right place and reduce the patient's chances of coming back.The use of intravascular ultrasound or computed tomography should ideally be used in every hemodynamically stable case.The instructions for use state, "native lumen dimensions must be accurately measured, not estimated.".
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