NEUROFORM ATLAS 4.0MM X 15MM NO TIP - CE

Additional Manufacturer Narrative

DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION THE STENT WAS RECEIVED WITH THE DISTAL END DEPLOYED WITHIN THE LUMEN OF A MICROCATHETER. THE PROXIMAL END OF THE STENT WAS LOADED ON THE STENT DELIVERY WIRE (SDW) WITHIN THE INTRODUCER SHEATH. THE DISTAL END OF THE STENT WAS ABLE TO BE REMOVED FROM THE LUMEN OF THE MICROCATHETER. THE STENT WAS UNABLE TO BE DEPLOYED FROM THE INTRODUCER SHEATH BY ADVANCING THE SDW. THE STENT WAS MANUALLY REMOVED FROM THE SHEATH. THE STENT WAS DEFORMED. ALL THREE MARKER BANDS WERE PRESENT ON BOTH ENDS OF THE STENT. THE SDW DISTAL TIP WAS BROKEN DURING ANALYSIS AND WILL NOT BE CODED FOR. THE INTRODUCER SHEATH WAS NOTED TO BE INTACT. THE FUNCTIONAL INSPECTION WAS UNABLE TO BE PERFORMED AS THE STENT WAS RETURNED IN A DEPLOYED STATE. THE REPORTED EVENT 'STENT DIFFICULT/UNABLE TO ADVANCE OR PULLBACK THROUGH CATHETER' COULD NOT BE REPLICATED. HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. 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. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS PREPARED FOR USE AS PER THE DIRECTIONS FOR USE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO OPENING THE PACKAGING AND THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT. CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE, AND THE PATIENTS ANATOMY WAS DESCRIBED AS 'NOT TORTUOUS'. IT WAS REPORTED THAT 'DA GUIDEWIRE WAS USED TO GUIDE DUAL MICROCATHETERS TO THE LESION SITE. AFTER SEVERAL COILS WERE IMPLANTED THROUGH THE FIRST EMBOLIZATION MICROCATHETER, A STENT WAS PUSHED THROUGH THE SECOND MICROCATHETER. DURING THE PUSHING PROCESS, THIS STENT COULD NOT BE ADVANCED FROM THE INTRODUCING SHEATH INTO THE MICROCATHETER. AFTER WITHDRAWING IT, THE PHYSICIAN REPLACED IT WITH A SECOND STENT OF THE SAME MODEL. THE SECOND STENT GOT STUCK WHEN BEING PUSHED AT THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN THEN WITHDREW THE STENT ALONG WITH THE MICROCATHETER TOGETHER OUT OF THE BODY. SUBSEQUENTLY, A THIRD STENT OF THE SAME MODEL WAS PUSHED THROUGH THE FIRST EMBOLIZATION MICROCATHETER. THIS STENT WAS SUCCESSFULLY DELIVERED AND DEPLOYED, COMPLETING THE PROCEDURE. AFTER THE PROCEDURE, THE PHYSICIAN INTENTIONALLY DEPLOYED THE FIRST STENT OUTSIDE FROM THE MICROCATHETER FOR INSPECTION'. NOTE: THIS COMPLAINT REFERS TO THE 2ND STENT. EXCELSIOR SL-10 AND XT-17 ARE THE RECOMMENDED MICROCATHETERS TO USE WHEN DELIVERING A NEUROFORM ATLAS STENT, BECAUSE THE INTERNAL HUB PROFILE OF BOTH THESE MICROCATHETERS ARE AN EXACT MATCH FOR THE EXTERNAL PROFILE OF THE DISTAL TIP OF THE ATLAS INTRODUCER SHEATH. THIS IS NOT THE CASE FOR ECHELON-10. PRECISE PLACEMENT OF THE INTRODUCER SHEATH IS CRITICAL WHEN USING AN ECHELON-10 MICROCATHETER (MC). THE STENT WAS RETURNED FOR ANALYSIS IN A PARTIALLY DEPLOYED CONDITION, WITH THE DISTAL END OF THE STENT DEPLOYED INSIDE THE LUMEN OF THE MICROCATHETER (MC), THE MIDDLE OF THE STENT PRESENT INSIDE THE HUB OF THE MC AND THE PROXIMAL END OF THE STENT STILL LOADED ON THE STENT DELIVERY WIRE (SDW) AND STILL INSIDE THE INTRODUCER SHEATH. THE STENT WAS REMOVED FROM THE SHEATH AND THE MC WAS NOTED TO BE DEFORMED. THE SDW WAS NOTED TO BE UNDAMAGED PRIOR TO IT BEING REMOVED FROM THE INTRODUCER SHEATH. DURING THIS REMOVAL PROCESS, THE SDW WAS BROKEN/FRACTURED. THIS DAMAGE WILL NOT BE CODED FOR. THE INTRODUCER SHEATH WAS RETURNED AND WAS UNDAMAGED. ACCORDING TO THE EVENT DESCRIPTION, THE 2ND STENT (WHICH IS THE SUBJECT OF THIS INVESTIGATION) GOT STUCK IN THE DISTAL END OF THE MC. BASED ON THE CONDITION OF THE RETURNED DEVICES, IT APPEARS THAT THE STENT WAS RETRACTED TO THE PROXIMAL END OF THE MC, AND AN UNSUCCESSFUL ATTEMPT WAS MADE TO RELOAD THE STENT INTO THE INTRODUCER SHEATH. IT IS UNCLEAR WHY THE STENT GOT STUCK WHEN IT HAD REACHED THE DISTAL END OF THE MC. IT IS LIKELY THAT, DUE TO SOME UNKNOWN PROCEDURAL FACTOR AND/OR THE TORTUOUS NATURE OF THE TARGET ANATOMY, THE USER EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE STENT. MUCH OF THE DAMAGE NOTED DURING ANALYSIS IS LIKELY TO HAVE BEEN CAUSED DURING EFFORTS TO RETRACT THE STENT FROM THE MICROCATHETER AND RELOAD IT INTO THE INTRODUCER SHEATH. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS HAS BEEN ASSIGNED TO THE REPORTED EVENT 'STENT DIFFICULT/UNABLE TO ADVANCE OR PULLBACK THROUGH CATHETER' AND TO THE ANALYZED EVENT ¿STENT DEPLOYED PREMATURELY DURING USE AND ¿STENT DEFORMED¿ 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/ANATOMICAL FACTORS DURING USE.

Description of Event or Problem

IT WAS REPORTED THAT DURING A LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE SUBJECT STENT GOT STUCK WHEN BEING PUSHED AT THE DISTAL END OF THE MICROCATHETER. HOWEVER, THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT STENT HAD DEPLOYED PREMATURELY DURING USE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.