WALLSTENT ENDOPROSTHESIS

Additional Manufacturer Narrative

E1 - INITIAL REPORTER ADDRESS: (B)(6). THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITH THE STENT IN THE CORRECT POSITION ON THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE TIP OF THE DEVICE. A VISUAL AND TACTILE INSPECTION IDENTIFIED KINKING TO THE SHEATH OF THE DEVICE AT MORE THAN ONE LOCATION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

Description of Event or Problem

IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED LOCATED IN THE NON-TORTUOUS LEFT ILIAC VEIN. A 75CM WALLSTENT UNI CATHETER WAS USED FOR TREATMENT. HOWEVER, UPON UNPACKING, IT WAS NOTED THAT THERE WAS A CREASE AT THE TIP OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

Additional Manufacturer Narrative

E1 - INITIAL REPORTER ADDRESS: (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED LOCATED IN THE NON-TORTUOUS LEFT ILIAC VEIN. A 75CM WALLSTENT UNI CATHETER WAS USED FOR TREATMENT. HOWEVER, UPON UNPACKING, IT WAS NOTED THAT THERE WAS A CREASE AT THE TIP OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.