NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE

Additional Manufacturer Narrative

DUE TO THE AUTOMATED MES (MANUFACTURING EXECUTION SYSTEM) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE STENT WAS RECEIVED DEPLOYED WITHIN THE PROXIMAL END OF THE MICROCATHETER. THE STENT DELIVERY WIRE (SDW) AND INTRODUCER SHEATH WERE RETURNED. THE MICROCATHETER WAS ABLE TO BE FLUSHED. THE MICROCATHETER WAS CUT IN AN ATTEMPT TO REMOVE THE STENT, HOWEVER THE STENT COULD NOT BE FULLY REMOVED. ALL THREE MARKER BANDS WERE PRESENT ON THE PROXIMAL END OF THE STENT. THE SDW DISTAL TIP WAS KINKED/BENT. THE INTRODUCER SHEATH WAS NOTED TO BE INTACT. A FUNCTIONAL INSPECTION WAS NOT PERFORMED 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 'STENT DIFFICULT/UNABLE TO ADVANCE OR PULLBACK THROUGH CATHETER' AND 'STENT DEFORMED' COULD NOT BE REPLICATED AS THE STENT WAS NO LONGER LOADED ON THE SDW. IN ADDITION, THE STENT WAS UNABLE TO BE REMOVED FROM THE MICROCATHETER LUMEN. THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALY NOTED TO THE DEVICE. THE INTERNAL HUB PROFILE OF THE MICROCATHETER IS AN EXACT MATCH FOR THE EXTERNAL PROFILE OF THE DISTAL TIP OF THE STENT INTRODUCER SHEATH. CORRECTLY PLACEMENT OF THE INTRODUCER SHEATH DISTAL TIP INTO THE HUB OF THIS MICROCATHETER WILL THEREFORE ENSURE EASE OF TRANSFER OF THE STENT FROM THE SHEATH INTO THE MICROCATHETER LUMEN. BASED ON THE ANALYSIS RESULTS AND THE LIMITED INFORMATION AVAILABLE IN THE EVENT DESCRIPTION, IT IS POSSIBLE THAT THE INTRODUCER SHEATH WAS POSITIONED SLIGHTLY PROXIMALLY WITHIN THE CATHETER HUB, OR IT WAS INITIALLY CORRECTLY POSITIONED BUT SUBSEQUENTLY MOVED PROXIMALLY PRIOR TO STENT ADVANCEMENT OUT OF THE SHEATH. 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 PARTIALLY DEPLOY INTO THE GAP (CAUSED BY THE PROXIMAL SHEATH MOVEMENT). THIS CONCLUSION IS SUPPORTED BY THE LACK OF DAMAGE NOTED TO THE DISTAL END OF THE INTRODUCER SHEATH. THE USER WOULD, AS A CONSEQUENCE, EXPERIENCE RESISTANCE DURING ATTEMPTS TO ADVANCE THE STENT THROUGH THE MICROCATHETER LUMEN. UPON REALIZING THIS, THE USER NORMALLY ATTEMPTS TO WITHDRAW THE STENT. DURING THIS ACTION, THE STENT APPEARS TO HAVE DEPLOYED INSIDE THE LUMEN OF THE CATHETER. THIS IS THE MOST LIKELY EXPLANATION FOR THE DAMAGE/OBSERVATIONS NOTED DURING ANALYSIS AND THE INFORMATION PROVIDED IN THE EVENT DESCRIPTION. THE LACK OF CONTINUOUS FLUSH IS LIKELY TO HAVE BEEN A CONTRIBUTING FACTOR IN THIS COMPLAINT DEVICE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS HAS BEEN ASSIGNED TO THE AS REPORTED AND AS ANALYZED CODES AS THIS COMPLAINT APPEARS TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL FACTORS DURING USE.

Description of Event or Problem

THE STENT (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT STENT WAS PREMATURELY DEPLOYED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.