WALLSTENT ENDOPROSTHESIS

Description of Event or Problem

IT WAS REPORTED THAT STENT PROFILE PROBLEM WAS ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ILIAC VEIN. A 14X60/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS SELF EXPANDING WAS ADVANCED FOR TREATMENT OF THE PATIENT PRESSURE SYNDROME. THE STENT WAS DEPLOYED NORMALLY; HOWEVER, AFTER DEPLOYING ABOUT TWO CENTIMETERS, THE STENT EJECTED ITSELF FROM THE DELIVERY SYSTEM AND THE DELIVERY SYSTEM BOUNCED OFF AND RETREATED TO THE SHEATH ORIFICE OF THE VESSEL. IT APPEARED THAT THE STENT WAS NOT FULLY OPENED. ANGIOGRAPHY REVEALED THAT THE ANTERIOR PORTION OF THE STENT WAS APPOSED TO THE VESSEL WALL WHILE THE POSTERIOR HALF WAS NOT, AND A BLOCKAGE HAD FORMED IN THE LUMEN CAUSING CONTRAST RETENTION. AFTER POST-DILATATION, RADIOGRAPHY SHOWED IMPROVEMENT IN FLOW RATE AND STAGNATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THIS EVENT.

Additional Manufacturer Narrative

(B)(6).

Additional Manufacturer Narrative

E1-INITIAL REPORTER ADDRESS 1: NO. (B)(6). DEVICE EVALUATED BY MFR.: THE WALLSTENT UNI WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RECEIVED WITH THE STENT ALREADY DEPLOYED FROM THE DELIVERY SYSTEM. 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 AND SHAFT OF THE DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT STENT PROFILE PROBLEM WAS ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ILIAC VEIN. A 14X60/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS SELF EXPANDING WAS ADVANCED FOR TREATMENT OF THE PATIENT PRESSURE SYNDROME. THE STENT WAS DEPLOYED NORMALLY; HOWEVER, AFTER DEPLOYING ABOUT TWO CENTIMETERS, THE STENT EJECTED ITSELF FROM THE DELIVERY SYSTEM AND THE DELIVERY SYSTEM BOUNCED OFF AND RETREATED TO THE SHEATH ORIFICE OF THE VESSEL. IT APPEARED THAT THE STENT WAS NOT FULLY OPENED. ANGIOGRAPHY REVEALED THAT THE ANTERIOR PORTION OF THE STENT WAS APPOSED TO THE VESSEL WALL WHILE THE POSTERIOR HALF WAS NOT, AND A BLOCKAGE HAD FORMED IN THE LUMEN CAUSING CONTRAST RETENTION. AFTER POST-DILATATION, RADIOGRAPHY SHOWED IMPROVEMENT IN FLOW RATE AND STAGNATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THIS EVENT.