WALLSTENT ENDOPROSTHESIS

Description of Event or Problem

IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO RE-CONSTRAIN. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT LOWER LIMB VEIN. A WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT REACHED THE LESION. HOWEVER, THE STENT WAS DEPLOYED LESS THAN 50% AND A RESISTANCE WAS OBVIOUS. THE STENT WAS HALF RE-CONSTRAINED AND WAS REMOVED DIRECTLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

Additional Manufacturer Narrative

THE STENT WAS RETURNED PARTIALLY DEPLOYED. THE STENT WAS DEPLOYED WITHOUT ISSUE AND NO ISSUES WERE NOTED WITH THE STENT. A VISUAL EXAMINATION IDENTIFIED NO DAMAGE OR ISSUES WITH THE STENT CUPS OR STENT HOLDER OF THE RETURNED DEVICE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

Description of Event or Problem

IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO RE-CONSTRAIN. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT LOWER LIMB VEIN. A WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT REACHED THE LESION. HOWEVER, THE STENT WAS DEPLOYED LESS THAN 50% AND A RESISTANCE WAS OBVIOUS. THE STENT WAS HALF RE-CONSTRAINED AND WAS REMOVED DIRECTLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.