NEUROFORM ATLAS 3.0MM X 24MM NO TIP - CE

Additional Manufacturer Narrative

DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE DISTAL END OF THE SUBJECT STENT WAS DEPLOYED WITHIN THE LUMEN OF THE MICROCATHETER. THE STENT DELIVERY WIRE (SDW) AND THE INTRODUCER SHEATH WERE RETURNED. THE STENT COULD NOT BE REMOVED FROM THE SL-10. THE STENT WAS NOTED TO BE DEFORMED. ALL THREE MARKER BANDS WERE PRESENT ON THE PROXIMAL END OF THE STENT. THE SDW WAS KINKED/BENT AT THE DISTAL END. THE INTRODUCER SHEATH WAS DAMAGED. THE SL-10 WAS NOTED TO BE INTACT. THE FUNCTIONAL INSPECTION WAS UNABLE TO PERFORM AS THE STENT WAS RETURNED IN A DEPLOYED STATE. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE AS REPORTED CODE 'NV - STENT DEPLOYED PREMATURELY DURING RETRACTION/RE-SHEATHING' WAS NOT CONFIRMED DURING ANALYSIS. THE SECOND AS REPORTED CODE 'STENT DIFFICULT/UNABLE TO TRANSFER' COULD NOT BE REPLICATED. HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEVICE WAS PREPARED AS PER THE DFU. THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO OPENING THE PACKAGING AND THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE ON THE PATIENT. CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE. IT WAS REPORTED THAT 'THE PHYSICIAN USED A STENT. AFTER PREPARATION, WHEN THE PHYSICIAN WAS DELIVERING THE STENT INTO THE MICROCATHETER, A SIGNIFICANT RESISTANCE WAS FELT AT THE HUB OF THE MICROCATHETER. AFTER ADJUSTING THE ANGLE, THE PHYSICIAN APPLIED MORE FORCE FOR DELIVERY, AND HALF OF THE STENT WAS DELIVERED INTO THE MICROCATHETER BEFORE IT GOT STUCK INSIDE. THE PHYSICIAN THEN ATTEMPTED TO RETRIEVE AND RE-DELIVER THE STENT. DURING THE RETRIEVAL PROCESS, THE STENT WAS ACCIDENTALLY DEPLOYED AT THE HUB OF THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN REPLACED BOTH THE MICROCATHETER AND THE STENT WITH NEW ONES TO COMPLETE THE PROCEDURE'. THE STENT WAS RETURNED FOR ANALYSIS IN A DEPLOYED CONDITION, WITH THE DISTAL PART OF THE STENT DEPLOYED INSIDE THE PROXIMAL LUMEN OF THE MICROCATHETER, AND THE PROXIMAL END OF THE STENT DEPLOYED INSIDE THE MICROCATHETER HUB OF THE MICROCATHETER. THE STENT WAS NOTED TO BE DEFORMED (THE STENT WAS STUCK INSIDE THE MICROCATHETER LUMEN AND COULD NOT BE REMOVED). THE STENT DELIVERY WIRE (SDW) WAS STILL PRESENT INSIDE THE STENT. HOWEVER, THE STENT WAS NOT LOADED ONTO THE CORRECT PART OF THE SDW. WHEN THE SDW WAS REMOVED OUT OF THE MICROCATHETER LUMEN, THE STENT WAS UNABLE TO BE REMOVED AND WAS TIGHTLY STUCK IN THE LUMEN. THE SDW WAS NOTED TO BE KINKED/BENT TOWARDS THE DISTAL END OF THE WIRE AND TOWARDS THE MIDDLE OF THE WIRE. THE DISTAL TIP OF THE INTRODUCER SHEATH WAS NOTED TO BE DAMAGED. PER THE FOLLOW-UP GOOD FAITH EFFORTS (GFE) RESPONSES, IT IS LIKELY THAT THE INTRODUCER SHEATH WAS INITIALLY SET UP CORRECTLY BUT SUBSEQUENTLY MOVED DISTALLY PRIOR TO STENT ADVANCEMENT OUT OF THE SHEATH. THIS IS SUPPORTED BY THE DAMAGE NOTED TO THE DISTAL TIP OPENING OF THE SHEATH DURING VISUAL INSPECTION. IF THIS WERE TO OCCUR, IT IS LIKELY THAT, DURING ADVANCEMENT OF THE STENT TO TRANSFER IT FROM THE SHEATH INTO THE PROXIMAL END OF THE MICROCATHETER LUMEN, THE STENT WOULD BECOME DAMAGED AS IT PASSES THROUGH THE DEFORMED DISTAL TIP OPENING OF THE SHEATH. THE USER WILL THEN EXPERIENCE INCREASED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE STENT INTO THE MICROCATHETER. UPON REALIZING THIS, THE USER NORMALLY ATTEMPTS TO WITHDRAW THE SDW AND STENT BACK INTO THE INTRODUCER SHEATH. IF THE STENT IS FIRMLY WEDGED INSIDE THE MICROCATHETER LUMEN, THE SDW MAY MOVE INDEPENDENTLY OF THE STENT. IN THE CASE OF THIS COMPLAINT, THE SDW APPEARS TO HAVE BEEN ADVANCED DISTALLY THROUGH THE STENT. THIS IS THE MOST LIKELY EXPLANATION FOR THE DAMAGE/OBSERVATIONS NOTED DURING ANALYSIS AND THE INFORMATION PROVIDED IN THE EVENT DESCRIPTION. THE AS REPORTED CODES "STENT DIFFICULT/UNABLE TO TRANSFER" , " STENT DEPLOYED PREMATURELY DURING RETRACTION/RE-SHEATHING" AS WELL AS THE AS ANALYZED CODES "STENT DEPLOYED PREMATURELY DURING USE" ," STENT DEFORMED" , "SDW KINKED/BENT" , " STENT INTRODUCER SHEATH DISTAL TIP DAMAGED" LISTED IN THE GRID BELOW WILL BE ASSIGNED PROCEDURAL FACTORS AS THIS COMPLAINT APPEARS TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS, AND WAS REPORTED TO HAVE BEEN USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL FACTOR(S) DURING PRODUCT TRANSFER/USE.

Description of Event or Problem

THE SUBJECT STENT WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT STENT DISTAL PART WAS DEPLOYED INSIDE THE PROXIMAL LUMEN OF THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.