WALLSTENT ENDOPROSTHESIS

Additional Manufacturer Narrative

E1 - INITIAL REPORTER ADDRESS 1: (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT SHAFT BREAK, REMOVAL DIFFICULTY, AND PARTIAL DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY VEINS. A 12X90/8FR UNI PLUS HALO 75CM WALLSTENT UNI WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS DELIVERED INTO THE BODY AND DEPLOYED AFTER REACHING THE LESION SITE. DURING THE DEPLOYMENT, THE DELIVERY SHAFT WAS FRACTURED, AND THE TAIL END COULD NOT BE PULLED. AFTER MANY ROTATIONS, THE STENT COULD NOT BE PULLED. THE STENT WAS ONLY DEPLOYED AT THE TIP END, AND THE BACK PART WAS NOT DEPLOYED. THE PHYSICIAN USED THE ADJUSTABLE CURVED SHEATH TO PULL OUT THE STENT AFTER MANY ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS POST PROCEDURE WAS STABLE.