WALLSTENT ENDOPROSTHESIS

Additional Manufacturer Narrative

DEVICE EVALUATED BY MFR: THE WALLSTENT UNI WAS RETURNED FOR ANALYSIS. THE STENT WAS RETURNED PARTIALLY DEPLOYED BY 15MM. THE STENT WAS NOTED TO BE DAMAGED ON THE DISTAL END. 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 AND SHAFT OF THE DEVICE. THIS CONCLUDES THE PRODUCT ANALYSIS.

Description of Event or Problem

IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT AND DEFORMATION OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14X90/9FR WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR STENT IMPLANTATION. HOWEVER, BEFORE THE STENT IMPLANTATION, IT WAS NOTED THAT PART OF THE TIP OF THE STENT HAD BEEN DEPLOYED WITHOUT INITIATING DEPLOYMENT. SUBSEQUENTLY, THE STENT WAS DEFORMED. THE STENT WAS RECONSTRAINED PRIOR TO REMOVAL BUT THERE WAS RELATIVELY HIGH RESISTANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.