WALLSTENT ENDOPROSTHESIS

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12X90/8FR WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT BE DEPLOYED, AND IT WAS DIFFICULT TO WITHDRAW. THE PROCEDURE WAS NOT COMPLETED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12X90/8FR WALLSTENT ENDOPROSTHESIS SELF EXPANDING STENT WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT BE DEPLOYED, AND IT WAS DIFFICULT TO WITHDRAW. THE PROCEDURE WAS NOT COMPLETED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS UNDER LOCAL ANESTHESIA. THE TARGET LESION WAS LOCATED 70% STENOSED, MODERATELY TORTUOUS AND MODERATELY CALCIFIED. THE STENT WAS NORMALLY RECAPTURED INTO THE CATHETER.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RECEIVED WITH THE STENT FULLY CONSTRAINED IN THE CORRECT POSITION ON THE DEVICE. THE INVESTIGATOR SUCCESSFULLY DEPLOYED THE STENT WITH NO RESISTANCE EXPERIENCED. A VISUAL EXAMINATION IDENTIFIED NO ISSUES OR DAMAGE TO THE DEPLOYED STENT. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO DAMAGE OR ISSUES WITH THE TIP OR DELIVERY SYSTEM. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.