TREVO NXT 6MM X 37MM - US

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE RETRIEVER SHAPED SECTION WAS NOTED TO HAVE BEEN BROKEN/FRACTURED FROM THE CORE WIRE AT 9.5 CM FROM THE MSJ (MID SOLDER JOINT) TO PEBAX TRANSITION. THE PROXIMAL FRACTURE WAS IMAGED. THE DISTAL FRACTURE WAS IMAGED. THE CORE WIRE WAS KINKED AT 3CM PROXIMAL TO THE FRACTURE POINT. THE CORE WIRE WAS KINKED AT 1.5CM DISTAL TO THE FRACTURE POINT. DURING FUNCTIONAL TEST, THE RETRIEVER SHAPED SECTION WAS FOUND WITHIN THE RETURNED CATHETER. 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 ¿RETRIEVER CORE WIRE BROKEN DURING USE' AND ¿DIFFICULT/UNABLE TO WITHDRAW RETRIEVER¿ WERE CONFIRMED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER THE STENT WAS BROKEN OFF WHILE RETRIEVING THE THROMBUS. THE BROKEN STENT WAS RETRIEVED WITH A SNARE. 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. THE DEVICE WAS RETURNED FOR INVESTIGATION, AND THE CORE WIRE WAS SEEN TO BE KINKED/BEND AND BROKEN. THE RETRIEVER SHAPED SECTION WAS FOUND WITHIN THE RETURNED CATHETER. SEM (SCANNING ELECTRON MICROSCOPE) IMAGING WAS PERFORMED ON THE FRACTURE POINT SHOWING EVIDENCE OF DUCTILE OVERLOAD FAILURE UNDER BENDING AND TENSION. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED ¿RETRIEVER CORE WIRE BROKEN DURING USE¿ AND ¿DIFFICULT/UNABLE TO WITHDRAW RETRIEVER¿ AND AS ANALYZED ¿RETRIEVER CORE WIRE KINKED¿ AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE FOR M1 CEREBRAL INFARCTION IN A PATIENT, THERE WAS RESISTANCE WHEN THE SUBJECT STENT RETRIEVER WAS WITHDRAWN FROM THE PATIENT ANATOMY AND THE SUBJECT STENT CORE WIRE BROKE OFF WHILE RETRIEVING THE THROMBUS WITH ASPIRATION CATHETER. THE BROKEN SUBJECT STENT WAS RETRIEVED WITH A SNARE. RECANALIZATION COULD NOT BE OBTAINED; THE PROCEDURE WAS COMPLETED AS IT WAS. ALTHOUGH THE INFARCTED NEST HAS SPREAD, IT WAS NOT CAUSED BY A PRODUCT DEFECT.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE FOR M1 CEREBRAL INFARCTION IN A PATIENT, THERE WAS RESISTANCE WHEN THE SUBJECT STENT RETRIEVER WAS WITHDRAWN FROM THE PATIENT ANATOMY AND THE SUBJECT STENT CORE WIRE BROKE OFF WHILE RETRIEVING THE THROMBUS WITH ASPIRATION CATHETER. THE BROKEN SUBJECT STENT WAS RETRIEVED WITH A SNARE. RECANALIZATION COULD NOT BE OBTAINED; THE PROCEDURE WAS COMPLETED AS IT WAS. ALTHOUGH THE INFARCTED NEST HAS SPREAD, IT WAS NOT CAUSED BY A PRODUCT DEFECT.