NEUROFORM ATLAS 4.0MM X 21MM 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 SUBJECT STENT WAS RECEIVED IN A DEPLOYED CONDITION. THE STENT DELIVERY WIRE (SDW) AND THE INTRODUCER SHEATH WERE RETURNED. THE STENT WAS DEFORMED. ALL THREE MARKER BANDS WERE PRESENT ON BOTH ENDS OF THE STENT. THE SUBJECT STENT WAS BROKEN/FRACTURED AT THE PROXIMAL END. THE SUBJECT SDW WAS KINKED/BENT. THE INTRODUCER SHEATH 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 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 REPORTED 'STENT DEPLOYED PREMATURELY DURING RETRACTION/RE-SHEATHING' WAS CONFIRMED. THE REMAINING REPORTED 'STENT DIFFICULT/UNABLE TO ADVANCE OR PULLBACK THROUGH CATHETER' COULD NOT BE REPLICATED AS THE STENT WAS NO LONGER LOADED ON THE 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 'AFTER THE MICROCATHETER WAS PROPERLY POSITIONED DURING THE OPERATION, THE INTRODUCING SHEATH FOR THE STENT WAS INSERTED INTO THE Y-VALVE AND ALIGNED WITH THE TAIL END OF THE MICROCATHETER. THE PHYSICIAN BEGAN TO PUSH THE DELIVERY WIRE FOR ABOUT TWO CENTIMETERS WHEN RESISTANCE WAS FELT, MAKING IT DIFFICULT TO ADVANCE THE STENT. THE PHYSICIAN THEN WITHDREW THE DELIVERY WIRE FOR THE STENT, AND THE STENT DETACHED AT THE HUB OF THE MICROCATHETER'S TAIL END. THE SUBJECT STENT WAS RETURNED FOR ANALYSIS IN A DEPLOYED CONDITION. THE SUBJECT STENT WAS NOTED TO BE DEFORMED AT BOTH THE DISTAL AND PROXIMAL ENDS OF THE DEVICE AND THE PROXIMAL END WAS ALSO NOTED TO BE BROKEN/FRACTURED. THE STENT DELIVERY WIRE (SDW) WAS RETURNED AND WAS NOTED TO BE KINKED/BENT AT BOTH THE DISTAL AND PROXIMAL ENDS OF THE WIRE. THE INTRODUCER SHEATH WAS RETURNED AND WAS UNDAMAGED. BASED ON THE EVENT DESCRIPTION AND ANALYSIS RESULTS, ONE POSSIBILITY IS THAT THE INTRODUCER SHEATH WAS INITIALLY CORRECTLY POSITIONED AS WAS REPORTED BY THE CUSTOMER, BUT SUBSEQUENTLY (AND INADVERTENTLY) MOVED SLIGHTLY PROXIMALLY PRIOR TO STENT ADVANCEMENT OUT OF THE SHEATH (THIS IS SUPPORTED BY THE LACK OF DAMAGE NOTED TO THE DISTAL TIP 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 CREATED BETWEEN THE DISTAL END OF THE SHEATH AND THE PROXIMAL END OF THE MICROCATHETER LUMEN. THE USER WOULD EXPERIENCE INCREASED RESISTANCE DURING ATTEMPTS TO ADVANCE THE STENT INTO THE MICROCATHETER LUMEN. UPON REALIZING THIS (THROUGH INCREASED RESISTANCE), THE USER NORMALLY ATTEMPTS TO WITHDRAW THE STENT. DURING THIS ACTION, THE SUBJECT STENT CAN FULLY DEPLOY IN THE HUB OF THE MICROCATHETER. THIS IS THE MOST LIKELY EXPLANATION FOR THE DAMAGE/OBSERVATIONS NOTED DURING ANALYSIS AND THE INFORMATION PROVIDED IN THE EVENT DESCRIPTION. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS HAS BEEN ASSIGNED TO THE AS REPORTED ¿STENT DIFFICULT/UNABLE TO ADVANCE OR PULLBACK THROUGH CATHETER' AND 'STENT DEPLOYED PREMATURELY DURING RETRACTION/RE-SHEATHING' AND ANALYSED ¿ STENT DEPLOYED PREMATURELY DURING RETRACTION/RE-SHEATHING¿, ¿STENT DEFORMED¿, ¿STENT BROKEN/FRACTURED DURING USE, ¿SDW KINKED/BENT¿ 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

IT WAS REPORTED THAT WHEN THE PHYSICIAN BEGAN TO PUSH THE SUBJECT STENT DELIVERY WIRE FOR ABOUT TWO CENTIMETERS, RESISTANCE WAS FELT, MAKING IT DIFFICULT TO ADVANCE THE SUBJECT STENT. THE PHYSICIAN THEN WITHDREW THE SUBJECT STENT DELIVERY WIRE FOR THE SUBJECT STENT; THE SUBJECT STENT WAS DETACHED AT THE HUB OF THE MICROCATHETER'S TAIL END. 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 PROXIMAL END OF THE SUBJECT STENT WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.