EXCELSIOR SL-10 PRE-SHAPED 45 150CM

Description of Event or Problem

THE SUBJECT MICROCATHETER WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT FROM THE SUBJECT MICROCATHETER THERE WAS UNKNOWN MATERIAL POTENTIALLY POLYTETRAFLUOROETHYLENE (PTFE) WAS FOUND TO BE PRESENT ON THE STENT. 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) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE.DURING VISUAL INSPECTION, THE SUBJECT CATHETER WAS RETURNED WITH THE STENT DEPLOYED WITHIN THE LUMEN AT THE PROXIMAL END.THE CATHETER WAS CUT IN ORDER TO REMOVE THE STENT. THERE WAS AN UNKNOWN MATERIAL POTENTIALLY POLYTETRAFLUOROETHYLENE(PTFE) PRESENT ON THE STENT. THE CATHETER SHAFT WAS KINKED/BENT TOWARDS THE DISTAL END. DURING FUNCTIONAL INSPECTION, THE CATHETER SHAFT COULD NOT BE FLUSHED. A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE CATHETER SHAFT WHEN INSERTED INTO THE CATHETER HUB. A 0.0158" PATENCY MANDREL WAS ABLE TO BE COMPLETELY ADVANCED THROUGH THE MICROCATHETER, RESISTANCE WAS NOTED.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 EVENT WAS DEVICE PROBLEM UNKNOWN/UNCLEAR. THE DEVICE DID NOT MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE.IT WAS REPORTED "THE PATIENT 78 YEARS OLD, FEMALE WAS DIAGNOSED WITH AN ANTERIOR COMMUNICATING ARTERY ANEURYSM AND PLANNED TO UNDERGO STENT-ASSISTED COIL EMBOLIZATION. AFTER ESTABLISHING THE ACCESS SYSTEM, THE STENT WAS SELECTED, RETRIEVED FROM THE DISTRIBUTION LOOP, AND RINSED. DURING DELIVERY THROUGH THE MICROCATHETER, APPROXIMATELY ONE-FOURTH OF THE STENT WAS ADVANCED INTO THE MICROCATHETER WHEN FURTHER ADVANCEMENT BECAME IMPOSSIBLE. DESPITE SLIGHT WITHDRAWAL AND SUBSEQUENT RE-ATTEMPTS, SIGNIFICANT RESISTANCE PERSISTED, PREVENTING SUCCESSFUL ADVANCEMENT. THE MICROCATHETER AND STENT SYSTEM WERE THEREFORE WITHDRAWN AS AN ASSEMBLY. UPON EXTRACORPOREAL WITHDRAWAL OF THE STENT GUIDEWIRE, STENT DISLODGEMENT WITHIN THE MICROCATHETER WAS IDENTIFIED. A NEW MICROCATHETER AND STENT WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.".THE CATHETER WAS RETURNED WITH THE STENT DEPLOYED WITHIN THE LUMEN AT THE PROXIMAL END. THE CATHETER WAS CUT IN ORDER TO REMOVE THE STENT. THERE WAS AN UNKNOWN MATERIAL POTENTIALLY POLYTETRAFLUOROETHYLENE (PTFE) PRESENT ON THE STENT. THE CATHETER SHAFT WAS KINKED/BENT TOWARDS THE DISTAL END. THE CATHETER SHAFT COULD NOT BE FLUSHED. A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE CATHETER SHAFT WHEN INSERTED INTO THE CATHETER HUB. A 0.0158" PATENCY MANDREL WAS ABLE TO BE COMPLETELY ADVANCED THROUGH THE MICROCATHETER, RESISTANCE WAS NOTED.BASED ON THE AVAILABLE INFORMATION AND ANALYSIS OF THE RETURNED DEVICE, IT IS LIKELY THAT THE CATHETER PTFE INNER LAYER WAS DAMAGED WHEN RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT DURING THE PROCEDURE. ADDITIONAL DAMAGE TO THE CATHETER INNER LAYER MAY HAVE OCCURRED DURING ATTEMPTS TO REMOVE THE STENT FROM THE CATHETER LUMEN. THE CONCURRENT STENT MAY HAVE BEEN DAMAGED DURING TRANSFER, CAUSING FRICTION WITHIN THE CATHETER DUE TO PROCEDURAL FACTORS.THE AS REPORTED 'DEVICE PROBLEM UNKNOWN/UNCLEAR' AS WELL AS THE ANALYSED 'CATHETER SHAFT FRICTION', 'CATHETER SHAFT KINKED/BENT', 'CATHETER PTFE INNER LINING PEELING', AND 'DEVICE DIFFICULT TO FLUSH' 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.