TREVO NXT 4MM X 41MM - US

Description of Event or Problem

IT WAS REPORTED THAT DURING THE MIDDLE CEREBRAL ARTERY CLOT RETRIEVAL PROCEDURE, THE DISTAL ACCESS CATHETER AND MICROCATHETER COAXIALLY ADVANCED DISTAL TO THE LESION NAVIGATED BY THE GUIDEWIRE. THE SUBJECT DEVICE WAS PASSED THROUGH THE STENTED ARTERY AND DEPLOYED INSIDE THE PATIENT'S ANATOMY. DURING THE FIRST PASS, RECANALIZATION WAS NOT ACHIEVED. THEREFORE, A SECOND PASS WAS PERFORMED AS SAME AS THE FIRST PASS. WHILE RETRIEVING THE SUBJECT RETRIEVER, IT'S GOT STUCK IN THE PATIENT'S ANATOMY AND NOT ABLE TO BE REMOVED. THE PHYSICIAN ADVANCED THE DISTAL ACCESS CATHETER TO COVER THE SUBJECT RETRIEVER AND REMOVED TOGETHER FROM THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE MIDDLE CEREBRAL ARTERY CLOT RETRIEVAL PROCEDURE, THE DISTAL ACCESS CATHETER AND MICROCATHETER COAXIALLY ADVANCED DISTAL TO THE LESION NAVIGATED BY THE GUIDEWIRE. THE SUBJECT DEVICE WAS PASSED THROUGH THE STENTED ARTERY AND DEPLOYED INSIDE THE PATIENT'S ANATOMY. DURING THE FIRST PASS, RECANALIZATION WAS NOT ACHIEVED. THEREFORE, A SECOND PASS WAS PERFORMED AS SAME AS THE FIRST PASS. WHILE RETRIEVING THE SUBJECT RETRIEVER, IT'S GOT STUCK IN THE PATIENT'S ANATOMY AND NOT ABLE TO BE REMOVED. THE PHYSICIAN ADVANCED THE DISTAL ACCESS CATHETER TO COVER THE SUBJECT RETRIEVER AND REMOVED TOGETHER FROM THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

Additional Manufacturer Narrative

DEVICE EVALUATED BY MFG ¿UPDATED. SUMMARY ATTACHED - UPDATED. MANUFACTURING DATE ¿ ADDED. EXPIRATION DATE - ADDED. THE DEVICE HISTORY RECORD (DHR) CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DURING VISUAL INSPECTION, THE RETRIEVER SHAPED SECTION WAS DAMAGED AND THERE WAS PROCEDURAL FLUID ON THE SHAPED SECTION. THE RETRIEVER SHAPED SECTION STRUT WAS FOUND BROKEN AND THE CORE WIRE WAS FOUND KINKED. THE PEBAX WAS DAMAGED AT THE MID SOLDER. FUNCTIONAL TESTING COULD NOT BE CONFIRMED AS THE SUBJECT DEVICE WAS DAMAGED. 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. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT AND WAS PREPARE AS PER THE DFU, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE, THE TORTUOSITY OF THE PATIENT'S ANATOMY WAS NORMAL, RESISTANCE WAS ENCOUNTERED IN THE VESSEL DURING THE PROCEDURE, THE RETRIEVER PASSED THROUGH A STENTED ARTERY (MIDDLE CEREBRAL ARTERY), AND THE PROCEDURE WAS COMPLETED BY COVERING THE DEVICE WITH A DISTAL ACCESS CATHETER TO RETRIEVE THE CLOT. DURING ANALYSIS, THE RETRIEVER SHAPED SECTION WAS FOUND TO BE DAMAGED WITH ONE OF THE STENT STRUTS OBSERVED TO BE BROKEN. ADDITIONALLY, THE CORE WIRE WAS FOUND TO BE KINKED AND THE PEBAX WAS DAMAGED AT THE MID SOLDER JOINT. GIVEN THAT THERE WAS RESISTANCE NOTED IN THE VESSEL LIKELY DUE TO THE RETRIEVER PASSING THROUGH A STENTED ARTERY (MIDDLE CEREBRAL ARTERY), IT APPEARS THAT THE DEVICE WAS SUBJECT TO FORCES DURING THE PROCEDURE THAT LED TO THE OBSERVED DEFECTS AND REPORTED EVENT. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED 'DIFFICULT/UNABLE TO WITHDRAW RETRIEVER' AND 'RETRIEVER CLOT INTEGRATION ISSUE' AS WELL AS THE AS ANALYZED 'RETRIEVER PLATINUM WIRE DAMAGE/BREAK', 'RETRIEVER SHAPED SECTION DAMAGE' AND 'RETRIEVER CORE WIRE KINKED' SINCE THESE ISSUES ARE 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.