TREVO NXT 4MM X 41MM - CE

Description of Event or Problem

THE SUBJECT RETRIEVER WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT RETRIEVER SHAPED SECTION HAD BEEN FRACTURED FROM THE CORE WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT¿ MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE SUBJECT RETRIEVER CORE WIRE DISTAL END WAS NOTED TO BE EXTENSIVELY DEFORMED WITH THE RETRIEVER SHAPED SECTION DETACHED. THERE WAS NECKING NOTED TO THE CORE WIRE FRACTURE POINT. THE MICROCATHETER WAS RETURNED WITHIN THE ASPIRATION CATHETER. THERE WAS FLATTENING AND KINKING NOTED TO THE DISTAL SECTION OF THE ASPIRATION CATHETER. THERE WAS KINKING NOTED TO THE MICROCATHETER AT 28CM & 35CM FROM THE PROXIMAL END. DURING FUNCTIONAL INSPECTION THE MICROCATHETER WAS JAMMED WITHIN THE ASPIRATION CATHETER DUE TO THE DAMAGE NOTED TO THE DISTAL END OF THE ASPIRATION CATHETER. THE ASPIRATION CATHETER WAS FLUSHED, AND THE MICROCATHETER WAS REMOVED WITH FRICTION NOTED. ONCE REMOVED THE MICROCATHETER WAS NOTED TO BE DOUBLED OVER TO THE DISTAL 20MM SECTION WITH THE RETRIEVER SHAPED SECTION ENTANGLED. THE RETRIEVER SHAPED SECTION WAS DOUBLED OVER ON ITSELF AND EXTENSIVELY DEFORMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS 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 DIFFICULTY TO ADVANCE THE RETRIEVER THROUGH THE CATHETER WAS UNABLE TO BE REPLICATED, HOWEVER THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE RETUNED DEVICE FAILED TO MEET SPECIFICATION WHEN RETURNED DUE TO THE DAMAGE NOTED TO THE DEVICE. IT WAS REPORTED THAT THE RETRIEVER WAS STUCK IN THE DISTAL ACCESS CATHETER. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE, CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE, IT IS UNKNOWN IF THE ANATOMY WAS TORTUOUS, IT IS UNKNOWN IF THERE WAS ANY FORCE APPLIED TO OVERCOME RESISTANCE TO ADVANCE OR WITHDRAW THE RETRIEVER. THE DEVICE WAS RETURNED AND IT WAS NOTED THAT THE RETRIEVER SHAPED SECTION HAD BEEN FRACTURED FROM THE CORE WIRE, THERE WAS SIGNIFICANT DAMAGE NOTED TO THE DISTAL END OF THE CORE WIRE. THE RETURNED MICROCATHETER WAS RETURNED STUCK WITHIN THE GUIDE CATHETER, ONCE REMOVED THE RETRIEVER SHAPED SECTION WAS NOTED TO BE ENTANGLED WITHIN THE DISTAL TIP OF THE MICROCATHETER. THERE WAS KINKING AND FLATTENING NOTED TO THE DISTAL SECTION OF THE GUIDE CATHETER IN THE LOCATION WHERE THE MICROCATHETER AND THE RETRIEVER WERE STUCK. IT IS PROBABLE THAT THE GUIDE CATHETER WAS DAMAGED DURING THE PROCEDURE CAUSING THE MICROCATHETER AND THE RETRIEVER TO BECOME STUCK, THE RETRIEVER WAS LIKELY DAMAGED AND FRACTURED IN THE ATTEMPT TO MANEUVER AND REMOVE FROM THE DELIVERY SYSTEM. AN ASSIGNABLE CAUSE OF CAUSED BY OTHER WILL BE ASSIGNED TO THE REPORTED "RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT "AND TO THE ANALYZED "RETRIEVER CORE WIRE BROKEN DURING USE", "RETRIEVER CORE WIRE KINKED" AND "RETRIEVER SHAPED SECTION DAMAGE", AS THE INVESTIGATION REVEALED THAT THE ISSUE WAS CAUSED BY THE GUIDE CATHETER.