EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED

Additional Manufacturer Narrative

INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

Description of Event or Problem

DURING A BILIARY STENTING PROCEDURE, THE GUIDE WIRE OF THE PROSTHESIS (FLAP PART) FAILED TO DEPLOY CORRECTLY WHEN THE DEVICE WAS PLACED INTO FUSION MODE. AFTER MULTIPLE PERSISTENT ATTEMPTS, THE USER SUCCESSFULLY REMOVED THE GUIDEWIRE. FOLLOWING THIS, THE PROSTHESIS WAS ADVANCED INTO THE BILE DUCT BUT ENCOUNTERED RESISTANCE AT THE STENOSIS. DESPITE SEVERAL UNSUCCESSFUL ATTEMPTS TO PASS THE LESION, THE DEVICE HAD TO BE REMOVED, AND IT WAS DISCOVERED THAT THE PROSTHESIS HAD LOST ITS SHEATH. SPECIFICALLY, THE OLIVE AT THE TIP OF THE CATHETER HAD RETRACTED INSIDE THE SHEATH, CREATING A BLOCKAGE AT THE LEVEL OF THE WORKING CHANNEL PLUG AND PREVENTING THE STENT FROM ADVANCING THROUGH THE STENOSIS. THIS SITUATION NECESSITATED THE COMPLETE WITHDRAWAL OF ALL EQUIPMENT, AND THE PROCEDURE WAS COMPLETED USING A SEPARATE, REPLACEMENT STENT. WHEN THEY REFERRED TO THE ¿OLIVE¿, DO THEY REFER TO THE WHITE DISTAL TIP ON THE DEVICE? YES WHEN THEY MENTIONED THE ¿PROSTHESIS HAD LOST ITS SHEATH¿, DOES THIS MEAN THAT THE STENT HAS BEEN PARTIALLY DEPLOYED AND WHEN THEY TRIED TO RECAPTURE, THE STENT DID NOT RETURN TO THE SHEATH? THE WHITE DISTAL HAD ENTERED IN THE SHEATH WAS THE PRODUCT INSPECTED FOR DAMAGE BEFORE USE? YES ARE THERE ANY CLINICAL IMAGING OR VIDEOS OF THE PROCEDURE AVAILABLE? NO DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? 035 - 450CM - JAGWIRE. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? YES WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? DUODENOSCOPE PENTAX ED34I10T2 - 4.2. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? NO WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? NC WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? NO WAS THE SAFETY WIRE REMOVED? IF YES, AT WHAT POINT WAS IT REMOVED. NO WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NO WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? YES, IMPOSSIBLE TO ADVANCING THE DELIVERY SYSTEM. WHAT WAS THE POSITION OF THE ELEVATOR DURING ADVANCEMENT? OPEN. WHAT WAS THE POSITION OF THE ELEVATOR DURING ATTEMPTED DEPLOYMENT? OPEN. WAS THE DIRECTIONAL BUTTON PRESSED DURING USE? NO WAS THE DIRECTIONAL BUTTON PRESSED TO INITIATE RETRACTION? NO WAS A STENT PREVIOUSLY PLACED AT THE SAME OR ADJACENT LOCATION? NO WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE? DIFFICULTY TO ENTER THE WIRE GUIDE IN THE ZIP PORT.