NEUROFORM ATLAS 4.0MM X 15MM NO TIP - CE

Description of Event or Problem

IT WAS REPORTED THAT THE SUBJECT STENT GOT STUCK IN THE MIDDLE PART OF THE MICROCATHETER. WHEN THE PHYSICIAN WITHDREW THE SUBJECT STENT OUT, IT GOT DEPLOYED AT HUB OF MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT STENT WAS DEPLOYED PREMATURELY DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

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 SUBJECT STENT DELIVERY WIRE (SDW)AND THE INTRODUCER SHEATH WERE RETURNED. THE SUBJECT STENT COULD NOT BE REMOVED FROM THE MICROCATHETER. THE SDW WAS KINKED/BENT AT THE DISTAL END. THE INTRODUCER SHEATH DISTAL TIP WAS DAMAGED. THE FUNCTIONAL INSPECTION WAS UNABLE TO PERFORM AS THE SUBJECT STENT WAS RETURNED IN A DEPLOYED STATE. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTION 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 DEPLOYED PREMATURELY DURING RETRACTION/RE-SHEATHING' WAS NOT CONFIRMED AS PART OF THE STENT HAD DEPLOYED INSIDE THE MICROCATHETER LUMEN. THE REMAINING REPORTED CODE 'STENT DIFFICULT/UNABLE TO ADVANCE OR PULLBACK THROUGH CATHETER' COULD NOT BE REPLICATED AS THE STENT WAS NO LONGER LOADED ON THE SUBJECT STENT DELIVERY WIRE (SDW). 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 'SEVERAL COILS WERE IMPLANTED THROUGH THE FIRST INTRA-ANEURYSMAL MICROCATHETER, AND THEN A SUBJECT STENT WAS PUSHED INTO PLACE VIA THE SECOND MICROCATHETER. HOWEVER, THE SUBJECT STENT GOT STUCK IN THE MIDDLE PART OF THE MICROCATHETER. THE PHYSICIAN THEN WITHDREW THE SUBJECT STENT ALONG WITH THE MICROCATHETER TOGETHER, REPLACED IT WITH A NEW STENT OF THE SAME MODEL'. A PRODUCT CONDITION UPDATE WAS PROVIDED WHICH STATES 'WHEN THE PHYSICIAN WITHDREW THE STENT OUT, IT GOT DEPLOYED AT HUB OF MICROCATHETER'. STRYKER MICROCATHETERS ARE THE RECOMMENDED MICROCATHETERS TO USE WHEN DELIVERING A SUBJECT STENT, BECAUSE THE INTERNAL HUB PROFILE OF BOTH THESE MICROCATHETERS ARE AN EXACT MATCH FOR THE EXTERNAL PROFILE OF THE DISTAL TIP OF THE SUBJECT STENT INTRODUCER SHEATH. THIS IS NOT THE CASE FOR MICROCATHETER USED. PRECISE PLACEMENT OF THE INTRODUCER SHEATH IS CRITICAL WHEN USING A MICROCATHETER (MC). THE SUBJECT STENT WAS RETURNED FOR ANALYSIS IN A DEPLOYED CONDITION. THE DISTAL END OF THE SUBJECT STENT WAS DEPLOYED INSIDE THE PROXIMAL LUMEN OF A MICROCATHETER, LEAVING THE REMAINDER OF THE SUBJECT STENT DEPLOYED INSIDE THE HUB OF THE MC. THE SUBJECT STENT WAS NOTED TO BE DEFORMED BUT IT WAS NOT POSSIBLE TO REMOVE THE STENT FROM THE MICROCATHETER. THE STENT DELIVERY WIRE (SDW) WAS KINKED/BENT TOWARDS THE DISTAL END OF THE WIRE, AND THE DISTAL TIP OF THE INTRODUCER SHEATH WAS DAMAGED. ACCORDING TO THE EVENT DESCRIPTION, THE SUBJECT STENT GOT STUCK IN THE MIDDLE PART OF THE MC. BASED ON THE CONDITION OF THE RETURNED DEVICES, IT APPEARS THAT THE SUBJECT STENT WAS RETRACTED TO THE PROXIMAL END OF THE MC. AS THE PROXIMAL END OF THE SUBJECT STENT IS RETRACTED INTO THE MC HUB, THE DISTAL BUMPER OF THE SDW (WHICH IS SMALLER IN DIAMETER TO THE PROXIMAL BUMPER WHICH IS USED TO ADVANCE THE STENT) CAN SLIP THROUGH THE SUBJECT STENT, LEAVING THE SUBJECT STENT PARTIALLY DEPLOYED PREMATURELY INSIDE THE MICROCATHETER LUMEN. THIS IS THE MOST LIKELY EXPLANATION FOR THE DAMAGE/OBSERVATIONS NOTED DURING ANALYSIS AND THE INFORMATION PROVIDED IN THE EVENT DESCRIPTION. IT IS UNCLEAR WHY THE SUBJECT STENT GOT STUCK WHEN IT REACHED THE MIDDLE SECTION OF THE MC. IT IS LIKELY THAT, DUE TO SOME UNKNOWN PROCEDURAL FACTOR(S) AND/OR THE TORTUOUS NATURE OF THE TARGET ANATOMY, THE USER EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE SUBJECT SYSTEM. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS HAS BEEN ASSIGNED TO THE REPORTED CODE 'STENT DIFFICULT/UNABLE TO ADVANCE OR PULLBACK THROUGH CATHETER' AND THE AS ANALYZED ¿STENT DEPLOYED PREMATURELY DURING USE¿, ¿STENT DEFORMED¿, ¿SDW KINKED/BENT¿, ¿STENT INTRODUCER SHEATH DISTAL TIP DAMAGED¿ 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/ANATOMICAL FACTORS DURING USE. THE REPORTED CODE ¿STENT DEPLOYED PREMATURELY DURING RETRACTION/RE-SHEATHING' HAS BEEN ASSIGNED NOT CONFIRMED.