NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE

Description of Event or Problem

THE SUBJECT STENT WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT STENT WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

DUE TO AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) HAS CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. VISUAL/MICROSCOPIC INSPECTION WAS PERFORMED AS THE SUBJECT STENT WAS RECEIVED IN A DEPLOYED CONDITION, WHICH IS ALIGNED WITH THE EVENT DESCRIPTION. A NON-STRYKER DELIVERY WIRE WAS RETURNED. THE INTRODUCER SHEATH WAS NOT RETURNED. THE SUBJECT STENT WAS DEFORMED AND BROKEN/FRACTURED. ALL THREE MARKER BANDS WERE PRESENT ON BOTH ENDS OF THE SUBJECT STENT. FUNCTIONAL INSPECTION WAS UNABLE TO PERFORM AS THE SUBJECT STENT WAS RETURNED IN A DEPLOYED STATE. THE AS REPORTED ¿STENT DIFFICULT/UNABLE TO ADVANCE OR PULLBACK THROUGH CATHETER' AND ¿SDW (STENT DELIVERY WIRE) KINKED/BENT' COULD NOT BE REPLICATED AS THE SUBJECT STENT WAS RETURNED IN A DEPLOYED CONDITION. HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE RETURNED DEVICE DID NOT MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. 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. 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 'MODERATELY TORTUOUS'. IN THE FOLLOW-UP REPLIES, IT WAS NOTED BY THE USER THAT THE SUBJECT STENT WAS DEPLOYED OUTSIDE THE BODY ON PURPOSE. THE SUBJECT STENT WAS RETURNED FOR ANALYSIS IN A DEPLOYED CONDITION WHICH IS ALIGNED WITH THE EVENT DESCRIPTION. THE SUBJECT STENT WAS NOTED TO BE DEFORMED AND ALSO BROKEN/FRACTURED. A NON-STRYKER STENT DELIVERY WIRE (SDW) WAS RETURNED. THE INTRODUCER SHEATH WAS NOT RETURNED FOR ANALYSIS. ACCORDING TO THE EVENT DESCRIPTION, THE SUBJECT STENT WAS SUCCESSFULLY TRANSFERRED INTO THE MICROCATHETER (MC) LUMEN WITH NO ISSUES NOTED. THE SUBJECT STENT WAS THEN ADVANCED APPROXIMATELY 80CM INSIDE THE MC WHEN SIGNIFICANT RESISTANCE WAS NOTED. THIS ABILITY TO ADVANCE THE SUBJECT STENT THIS FAR DISTALLY IN THE MC IS NOT TYPICALLY ASSOCIATED WITH SUBJECT STENT TRANSFER DIFFICULTY. IT IS MORE LIKELY THAT, DUE TO SOME UNKNOWN PROCEDURAL FACTOR AND/OR THE TORTUOUS NATURE OF THE TARGET ANATOMY, THE USER EXPERIENCED RESISTANCE WHILE ATTEMPTING TO CONTINUE TO ADVANCE THE SUBJECT STENT. IT IS LIKELY THAT SOME OF THE DAMAGE NOTED DURING ANALYSIS MAY HAVE OCCURRED DURING EFFORTS TO REMOVE THE SUBJECT STENT FROM THE MICROCATHETER. HOWEVER, IT IS NOT CLEAR HOW THE SUBJECT STENT ENDED UP BROKEN/FRACTURED. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS HAS BEEN ASSIGNED TO THE AS REPORTED ¿STENT DIFFICULT/UNABLE TO ADVANCE OR PULLBACK THROUGH CATHETER' AND 'SDW KINKED/BENT' AND AS ANALYZED ¿STENT DEFORMED, STENT BROKEN/FRACTURED DURING USE¿ 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.