WALLSTENT ENDOPROSTHESIS

Description of Event or Problem

IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 25% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. UPON RELEASING, IT WAS NOTED THAT THE STENT WAS DIFFICULT TO DELIVER, AND PRE-DELIVERY WAS FAILED. THE STENT WAS PULLED OUT, AND IT WAS NOTED THAT THERE WERE BURRS AT THE TIP OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

DEVICE EVALUATED BY MFR: THE STENT WAS RETURNED PARTIALLY DEPLOYED BY APPROXIMATELY 5MM. 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 AND TO THE SHAFT. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

Description of Event or Problem

IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 25% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. UPON RELEASING, IT WAS NOTED THAT THE STENT WAS DIFFICULT TO DELIVER, AND PRE-DELIVERY WAS FAILED. THE STENT WAS PULLED OUT, AND IT WAS NOTED THAT THERE WERE BURRS AT THE TIP OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.