EXPRESS VASCULAR SD

Additional Manufacturer Narrative

(B)(6).

Description of Event or Problem

IT WAS REPORTED THAT THE STENT BECAME DISLODGED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 4.0MMX15MMX150CM EXPRESS SD STENT BALLOON EXPANDABLE WAS ELECTED FOR USE. DURING A PERCUTANEOUS RENAL ARTERY STENT PROCEDURE, THE STENT WAS OBSERVED TO BE DISLODGED HAVE SHIFTED FROM THE CENTER OF THE BALLOON AFTER THE BALLOON WAS OPENED. THE PHYSICIAN IMPLANTED AN ANOTHER STENT TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE AS A RESULT OF THIS EVENT.