It was reported that the stent partially deployed and then fractured upon removal.This 6 x 100 x 130 innova vascular stent was selected for use in a percutaneous transluminal angioplasty procedure.The 90% stenosed, moderately tortuous, moderately calcified target lesion was located in the superficial femoral artery.The stent was difficult to advance to the lesion.Once at the lesion, the stent would not deploy as the physician rolled the delivery thumb wheel.Then the thumb wheel stopped rolling completely and the physician then tried to pull the deployment handle; however, the stent did not deploy.The physician then attempted to remove the device, but a small portion of the stent was outside the delivery system, and it caught on the sheath while trying to remove the device from the patient.The stent had elongated and had broken into three pieces.The pieces of stent and the delivery system were pulled out with the wire still in the shaft, and the procedure was completed with a different device.There were no patient complications.The device was disposed of at the healthcare facility; therefore, not available for return.
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