WALLSTENT ENDOPROSTHESIS

Additional Manufacturer Narrative

DEVICE EVALUATE BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT WAS RETURNED PARTIALLY DEPLOYED BY APPROXIMATELY 25 MM. THE STENT WAS DEPLOYED WITHOUT ISSUE; HOWEVER, THE STENT WAS NOTED TO BE DAMAGED. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE TIP OF THE DEVICE BUT IDENTIFIED MULTIPLE OUTER SHEATH KINKS. WHEN THE STENT WAS DEPLOYED, THE INNER SHEATH WAS NOTED TO BE DAMAGED.

Description of Event or Problem

REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26NOV2024. IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ILIAC VEIN COMPRESSION. A 14 MM X 90 MM, 9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR STENTING. HOWEVER, DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED DUE TO GREAT RESISTANCE WHEN IT WAS HALF DEPLOYED. THE STENT WAS DIRECTLY RECAPTURED AND REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS UNHARMED, AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.