WALLSTENT ENDOPROSTHESIS

Description of Event or Problem

IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 16X60/9FR UNI PLUS 75CM WALLSTENT UNI STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT, AND ADVANCEMENT WAS NOT SMOOTH. AFTER REACHING THE LESION LOCATION, THE SHAFT WAS PULLED TO DEPLOY THE STENT; HOWEVER, THE STENT DID NOT RESPOND. RESISTANCE OCCURRED WHEN APPROXIMATELY ONE THIRD OF THE STENT HAD BEEN DEPLOYED. THE STENT WAS WITHDRAWN ALONG THE GUIDEWIRE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

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