TREVO NXT 4MM X 41MM - US

Description of Event or Problem

IT WAS REPORTED DURING THE THROMBECTOMY PROCEDURE THERE WAS RESISTANCE WHEN THE SUBJECT STENT RETRIEVER WAS PLACED. UPON REMOVAL OF THE STENT, IT WAS OBSERVED THAT THE DISTAL MESH OF THE STENT WAS DEFORMED. THE PHYSICIAN SUSPECTED THAT THERE MIGHT BE A BREAK IN THE MESH. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

Additional Manufacturer Narrative

D9 PRODUCT AVAILABLE TO STRYKER ¿ UPDATED. D9 RETURNED TO MANUFACTURER ON ¿UPDATED. H3 DEVICE EVALUATED BY MFG ¿UPDATED. DUE TO THE AUTOMATED (MANUFACTURING EXECUTION SYSTEM) MES SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE DISTAL END OF THE RETRIEVER SHAPED SECTION WAS NOTED TO HAVE A FRACTURE TO ONE OF THE STENT STRUTS. THERE WERE NO OTHER ANOMALIES NOTED TO THE RETRIEVER SHAPED SECTION. THERE WERE NO ANOMALIES NOTED TO THE INSERTION TOOL. DURING THE FUNCTIONAL INSPECTION THE INSERTION TOOL WAS FLUSHED AND THE RETRIEVER WAS ABLE TO BE ADVANCED WITHOUT DIFFICULTY. THE RETRIEVER WAS ADVANCED THROUGH A DEMONSTRATION MICROCATHETER, AND SOME SLIGHT RESISTANCE WAS NOTED AS THE RETRIEVER APPROACHED THE DISTAL END OF THE MICROCATHETER. THE REPORTED EVENT OF THE RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT AND RETRIEVER FRACTURED/BROKEN DURING USE WERE CONFIRMED. THE DEVICE FAILED TO MEET SPECIFICATION WHEN RETURNED DUE TO THE DAMAGE NOTED TO THE DEVICE. 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. IT WAS REPORTED THAT THE OPERATOR USED A STENT RETRIEVER. DURING THE FIRST THROMBECTOMY, THERE WAS SIGNIFICANT RESISTANCE. UPON REMOVAL OF THE STENT, IT WAS OBSERVED THAT THE DISTAL MESH OF THE STENT WAS DEFORMED. THE OPERATOR SUSPECTED THAT THERE MIGHT BE A BREAK IN THE MESH AND DECIDED TO REPLACE THE STENT RETRIEVER AND FINALLY THE VESSEL WAS SUCCESSFULLY RECANALIZED, AND THE SURGERY ENDED SMOOTHLY. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE AND THE PATIENTS ANATOMY WAS MODERATELY TORTUOUS. THE DEVICE WAS RETURNED AND IT WAS CONFIRMED THAT THE RETRIEVER SHAPED SECTION BRAID HAD FRACTURED TO THE DISTAL END OF THE SHAPED SECTION. THERE WAS DIFFICULTY TO ADVANCE THE RETRIEVER THROUGH THE DISTAL END OF A DEMONSTRATION MICROCATHETER. IT IS LIKELY THAT THE RETRIEVER WAS DAMAGED/ FRACTURED AS A RESULT OF THE SIGNIFICANT RESISTANCE EXPERIENCED DURING THE FIRST PASS, THE TORTUOSITY OF THE PATIENTS ANATOMY MAY HAVE CAUSED OR CONTRIBUTED TO THE RESISTANCE EXPERIENCED. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED EVENT OF THE RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT, RETRIEVER FRACTURED/BROKEN DURING USE, AND RETRIEVER SHAPED SECTION DAMAGE AND TO THE ANALYZED EVENT OF THE RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT AND RETRIEVER FRACTURED/BROKEN DURING USE, AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.

Description of Event or Problem

IT WAS REPORTED DURING THE THROMBECTOMY PROCEDURE THERE WAS RESISTANCE WHEN THE SUBJECT STENT RETRIEVER WAS PLACED. UPON REMOVAL OF THE STENT, IT WAS OBSERVED THAT THE DISTAL MESH OF THE STENT WAS DEFORMED. THE PHYSICIAN SUSPECTED THAT THERE MIGHT BE A BREAK IN THE MESH. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.