TREVO NXT 6MM X 37MM - CE

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT RETRIEVER WAS RETURNED FOR ANALYSIS; DURING VISUAL INSPECTION IT WAS OBSERVED THAT THE DISTAL PART OF THE RETRIEVER WAS RECOVERED DURING MICROCATHETER INVESTIGATION. THE CORE WIRE WAS SEEN TO BE BROKEN/FRACTURED AND KINKED. THE INSERTION TOOL WAS SEEN TO BE KINKED/BEND. THE RETRIEVER SHAPED SECTION WAS INTACT. FUNCTIONAL INSPECTION COULD NOT BE PERFORMED AS DEVICE WAS BROKEN/FRACTURED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTION 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 EVENT ¿RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT¿ COULD NOT BE REPLICATED DURING DEVICE ANALYSIS; HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE DEVICE FAILED TO MEET SPECIFICATION WHEN RETURNED DUE TO THE DAMAGE NOTED. IT WAS REPORTED THAT THE SUBJECT RETRIEVER STENT WOULD NOT ADVANCE THROUGH THE MICROCRATER AND BECAME ¿BUNCHED UP¿ IN THE MICROCATHETER. THE PHYSICIAN CONFIRMED THAT THE INTRODUCER SHEATH WAS RIGHT UP AGAINST THE HUB OF THE MICROCATHETER FOR TRANSFER. HE HAD TO REMOVE THE MICROCRATER AND STENT AND USE A DIFFERENT DEVICE TO COMPLETE THE TREATMENT. AS PER THE ADDITIONAL INFORMATION, THE CATHETER WAS FLUSHED TO FACILITATE THE RETRIEVER INSERTION, CONTINUOUS FLUSH WAS MAINTAINED FOR THE DURATION OF THE PROCEDURE AND THE DEVICE CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE. THE DEVICE WAS RETURNED AND THE DISTAL END OF THE CORE WIRE WITH RETRIEVER HAD BEEN FRACTURED WITHIN THE RETURNED MICROCATHETER. THERE WAS KINKING NOTED TO THE CORE WIRE AND TO THE INSERTION TOOL. THE RETURNED MICROCATHETER WAS NOTED TO HAVE SOME KINKING AND THERE WAS DRIED PROCEDURAL FLUIDS NOTED WITHIN. THE PRESENCE OF DRIED BLOOD WITHIN THE MICROCATHETER MAY BE AN INDICATION OF INSUFFICIENT FLUSH, WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS, THE KINKING NOTED TO THE EVEN THOUGH LOOKING INSIGNIFICANT, MAY ALSO BE A CONTRIBUTING FACTOR. IT IS PROBABLE THAT THESE AND/OR OTHER PROCEDURAL FACTORS PRESENT DURING USE MAY HAVE CAUSED THE REPORTED EVENTS AND THE DAMAGE NOTED TO THE RETURNED DEVICE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT AND TO THE ANALYSED RETRIEVER CORE WIRE KINKED AND RETRIEVER CORE WIRE BROKEN DURING USE, AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS COMPANY¿S DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED. IT IS LIKELY THAT THE INSERTION TOOL WAS KINKED AS A RESULT OF HANDLING OF THE DEVICE DURING USE OR PRIOR TO USE, IT IS NOT LIKELY TO BE RELATED TO THE REPORTED EVENT. AN ASSIGNABLE CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THE ANALYSED RETRIEVER INSERTION TOOL KINKED/BENT.

Description of Event or Problem

IT WAS REPORTED THAT IN A THROMBECTOMY CASE, THE SUBJECT STENT RETRIEVER WOULD NOT ADVANCE THROUGH THE MICROCATHETER AND BECAME ¿BUNCHED UP¿ IN THE MICROCATHETER. THE PHYSICIAN CONFIRMED THAT THE INTRODUCER SHEATH WAS RIGHT UP AGAINST THE HUB OF THE MICROCATHETER FOR TRANSFER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE STENT RETRIEVER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE CORE WIRE WAS BROKEN/FRACTURED DURING USE.