Description of Event or Problem · 1
DURING STENT DEPLOYMENT, THE PHYSICIAN NOTED SOME RESISTANCE WHILE ADVANCING THE THUMB SLIDE BUT WAS ABLE TO DEPLOY THE STENT. THE DEPLOYMENT COLLAR WAS OPENED, THE STENT WAS FULLY DEPLOYED AND THE DELIVERY CATHETER WAS WITHDRAWN. WHILE WITHDRAWING THE DELIVERY CATHETER THE PHYSICIAN EXPERIENCED A SLIGHT RESISTANCE AND THEN HE SAW THAT THE STENT WAS OUT OF THE ARTERY AND IN THE SHEATH. THE SHEATH WAS REMOVED AND REPLACED. AN ANGIOGRAM WAS PERFORMED WHICH SHOWED NO FLOW TO THE SFA OR DISTAL VESSELS. THE PT WAS GIVEN ANGIOMAX AND SCHEDULED FOR SURGERY. BY THE TIME THE PT ARRIVED FOR SURGERY, THERE WAS BLOOD FLOW NOTED IN THE TIBIAL VESSELS. THE PHYSICIAN STATED THAT THE PT WAS MOST LIKELY IN HYPERTHROMBOTIC STATE PRIOR TO THE INITIAL STENT IMPLANT; THE PT WAS NOT THROMBOTICALLY TREATED PRIOR TO THE PROCEDURE. THE PHYSICIAN ALSO INDICATED THAT THE TORTUOUS ILIAC BIFURCATION MAY HAVE BEEN THE CAUSE OF THE RESISTANCE AND THERE WAS NO CALCIFICATION NOTED. IT WAS NOTED THAT A .014 GUIDEWIRE WAS USED. THE PHYSICIAN STATED THAT THE WITHDRAWAL OF THE STENT LIKELY AGGRAVATED THE THROMBOTIC CONDITION. THE DEVICE WAS DISCARDED, THEREFORE, A DEVICE EVAL CANNOT BE COMPLETED.