TREVO NXT 4MM X 28MM - US

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT, WHILE RETRIEVING THE SUBJECT STENT INTO THE ASPIRATION CATHETER, THE CORE WIRE OF THE SUBJECT STENT RETRIEVER BROKE OFF INSIDE THE ASPIRATION CATHETER. THE BROKEN FRAGMENT WAS REMOVED FROM THE PATIENT ANATOMY BY REMOVING THE ASPIRATION CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT, WHILE RETRIEVING THE SUBJECT STENT INTO THE ASPIRATION CATHETER, THE CORE WIRE OF THE SUBJECT STENT RETRIEVER BROKE OFF INSIDE THE ASPIRATION CATHETER. THE BROKEN FRAGMENT WAS REMOVED FROM THE PATIENT ANATOMY BY REMOVING THE ASPIRATION CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

Additional Manufacturer Narrative

H4 MANUFACTURING DATE ADDED. H3 DEVICE EVALUATED BY MFG ¿UPDATED. H3 SUMMARY ATTACHED - UPDATED. D4 EXPIRATION DATE - ADDED. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL/MICROSCOPIC INSPECTION, THE RETRIEVER CORE WIRE WAS SEEN TO BE BROKEN FRACTURED 8MM FROM THE MSJ. THE INSERTION TOOL WAS NOT RETURNED. THE RETRIEVER SHAPED SECTION WAS CUT FROM THE CORE WIRE TO FACILITATE SCANNING ELECTRON MICROSCOPY SEM IMAGING OF THE FRACTURE TO THE CORE WIRE. FUNCTIONAL INSPECTION WAS NOT REQUIRED. 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 CORE WIRE FRACTURE WAS CONFIRMED DURING ANALYSIS. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. IT WAS REPORTED THAT DURING REMOVAL OF THE RETRIEVER WITHIN THE ASPIRATION CATHETER, THE RETRIEVER BROKE OFF THE CORE WIRE. THE FRAGMENT OF THE SUBJECT DEVICE WAS REMOVED FROM THE PATIENT VASCULATURE IN THE CATHETER, AND FLUSHED IT OUT OF THE CATHETER. THE DEVICE WAS RETURNED AND IT WAS CONFIRMED THAT THE CORE WIRE HAD BEEN FRACTURED. SEM ANALYSIS OF THE CORE WIRE FRACTURE SHOW EVIDENCE OF DUCTILE OVERLOAD FAILURE UNDER BENDING AND ROTATIONAL LOADING. IT IS PROBABLE THAT THE RETRIEVER CORE WIRE WAS SUBJECT TO STRESS DURING REMOVAL THROUGH THE ASPIRATION CATHETER, CAUSING THE REPORTED CORE WIRE FRACTURE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED AND ANALYZED RETRIEVER CORE WIRE BROKEN DURING USE, AS THE ISSUES IS 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 AND/OR ANATOMICAL FACTORS DURING USE.