EXCELSIOR SL-10 PRE-SHAPED 45 150CM

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE FOR A PATIENT THAT HAD A WIDE NECKED ACOMA ANEURYSM STENT ASSISTED COIL EMBOLIZATION WAS PLANNED. WHEN PUSHING THE STENT INTO THE SUBJECT MICROCATHETER FOR DELIVERY, THE PHYSICIAN ENCOUNTERED RESISTANCE IN THE MIDDLE SECTION . HOWEVER, THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THERE WAS CATHETER POLYTETRAFLUOROETHYLENE (PTFE) INNER LINING PEELING. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

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 MICROCATHETER WAS RETURNED WITH A STENT DEPLOYED WITHIN THE LUMEN AT THE PROXIMAL END. THE MICROCATHETER WAS CUT IN ORDER TO REMOVE THE STENT. THERE WAS AN UNKNOWN MATERIAL POTENTIALLY POLYTETRAFLUOROETHYLENE (PTFE) PRESENT ON THE STENT. DURING FUNCTIONAL INSPECTION THE MICROCATHETER SHAFT WAS ABLE TO BE FLUSHED. A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE MICROCATHETER SHAFT WHEN INSERTED INTO THE MICROCATHETER HUB. A 0.0158" PATENCY MANDREL WAS ABLE TO BE COMPLETELY ADVANCED THROUGH THE MICROCATHETER, RESISTANCE WAS NOTED WHERE THE STENT WAS LOCATED. THE REPORTED EVENT 'CATHETER SHAFT FRICTION' WAS CONFIRMED. 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 AND CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE. IT WAS REPORTED "THE PATIENT HAD A WIDE-NECKED ACOMA ANEURYSM, AND STENT-ASSISTED COIL EMBOLIZATION WAS PLANNED. AFTER DELIVERING THE STENT MICROCATHETER TO THE DESIGNATED POSITION, THE PHYSICIAN BEGAN TO ADVANCE THE STENT. WHEN PUSHING THE STENT INTO THE MICROCATHETER FOR DELIVERY, THE PHYSICIAN ENCOUNTERED RESISTANCE IN THE MIDDLE SECTION OF THE STENT AND FOUND IT IMPOSSIBLE TO ADVANCE FURTHER. SUBSEQUENTLY, THE PHYSICIAN REPLACED IT WITH A NEW PRE-SHAPED MICROCATHETER AND STENT TO COMPLETE THE PROCEDURE.". THE MICROCATHETER WAS RETURNED WITH AN STENT DEPLOYED WITHIN THE LUMEN AT THE PROXIMAL END. THE MICROCATHETER WAS CUT IN ORDER TO REMOVE THE STENT. THERE WAS AN UNKNOWN MATERIAL POTENTIALLY POLYTETRAFLUOROETHYLENE (PTFE) PRESENT ON THE STENT. THE MICROCATHETER SHAFT WAS ABLE TO BE FLUSHED. A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE MICROCATHETER SHAFT WHEN INSERTED INTO THE MICROCATHETER HUB. A 0.0158" PATENCY MANDREL WAS ABLE TO BE COMPLETELY ADVANCED THROUGH THE MICROCATHETER, RESISTANCE WAS NOTED WHERE THE STENT WAS LOCATED. BASED ON THE AVAILABLE INFORMATION AND ANALYSIS OF THE RETURNED DEVICE, IT IS LIKELY THAT THE PTFE INNER LAYER WAS DAMAGED WHEN RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT DURING THE PROCEDURE. THE CONCURRENT STENT MAY ALSO HAVE BEEN DAMAGED DURING TRANSFER DUE TO PROCEDURAL FACTORS. ADDITIONAL DAMAGE TO THE MICROCATHETER INNER LAYER MAY HAVE OCCURRED DURING ATTEMPTS TO REMOVE THE STENT FROM THE MICROCATHETER LUMEN. THE REPORTED EVENT 'CATHETER SHAFT FRICTION' AS WELL AS THE ANALYSED EVENT ¿CATHETER SHAFT FRICTION' AND 'CATHETER PTFE INNER LINING PEELING' WILL BE ASSIGNED A PROBABLE ASSIGNABLE CAUSE OF PROCEDURAL FACTORS 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.