TREVO NXT 4MM X 28MM - CE

Additional Manufacturer Narrative

THIS IS 1/2 REPORT. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL/MICROSCOPIC INSPECTION, THE RETRIEVER CORE WIRE WAS NOTED TO BE BROKEN/FRACTURED AT 199.5 CM FROM THE PROXIMAL END. THE RETRIEVER SHAPED SECTION WAS NOT RETURNED. THE INSERTION TOOL WAS NOT RETURNED. FUNCTIONAL INSPECTION WAS NOT CARRIED OUT 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. THE REPORTED EVENTS CAN BE CONFIRMED BASED ON THE DEVICE ANALYSIS. THE DEVICE FAILED TO MEET SPECIFICATION, BASED ON THE DAMAGE NOTED TO THE DEVICE. IT WAS REPORTED THAT THE PATIENT TORTUOSITY WAS PRETTY HIGH, PHYSICIAN MANAGED TO GET THE SOFIA6 UP AND PLACED THE STENT RETRIEVER THROUGH THE CLOT. AFTER 5-MIN SHE TRIED TO RETRIEVE THE SUBJECT STENT RETRIEVER BUT THE STENT BROKE LOSE FROM THE PUSHER WIRE. AFTER THAT THE PHYSICIAN TRIED TO GET THE SUBJECT STENT RETRIEVER OUT BY PUTTING ANOTHER (2ND) STENT RETRIEVER THROUGH BUT THESE INTERACTED AND RESULTED IN A PARTIALLY BROKEN 2ND RETRIEVER DEVICE. AS PER THE ADDITIONAL INFORMATION, RESISTANCE WAS ENCOUNTERED WHEN THE PHYSICIAN WANTED TO RETRIEVE THE SUBJECT STENT RETRIEVER. WHEN SHE WANTED TO PULL BACK THE SUBJECT STENT RETRIEVER THE PHYSICIAN NEEDED TO PULL STRONG AND THEN IT BROKE LOOSE. RESISTANCE WAS EXPERIENCED DURING RETRACTION OF THE SUBJECT STENT RETRIEVER. THE RETRIEVER CORE WIRE WAS RETURNED AND THE RETRIEVER SHAPED SECTION WAS NOTED TO HAVE BEEN DETACHED FROM THE CORE WIRE WITH A FRACTURE TO THE CORE WIRE. THE RETRIEVER SHAPED SECTION WAS NOT RETURNED. IT IS PROBABLE THAT THE RETRIEVER CORE WIRE FRACTURED AS A RESULT OF THE RESISTANCE EXPERIENCED DURING RETRACTION OF THE RETRIEVER. IT CANNOT BE DETERMINED IF THE PATIENTS ANATOMY MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED RETRIEVER CORE WIRE BROKEN DURING USE, UN-RETRIEVED DEVICE FRAGMENTS AND DIFFICULT/UNABLE TO WITHDRAW RETRIEVER AND TO THE ANALYZED RETRIEVER CORE WIRE 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. AN ASSIGNABLE CAUSE OF CAUSED BY OTHER WILL BE ASSIGNED TO THE REPORTED DEVICE INTERACTION WITH ANOTHER DEVICE, AS THE SECOND RETRIEVER WAS USED TO ATTEMPT TO REMOVE THE DETACHED SUBJECT RETRIEVER SHAPED SECTION.

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE FOR CAROTID TOP OCCLUSION, WHEN THE PHYSICIAN TRIED TO RETRIEVE THE SUBJECT STENT RETRIEVER, THERE WAS RESISTANCE AND IT BROKE LOSE FROM THE PUSHERWIRE. AFTER THAT THE PHYSICIAN TRIED TO GET THE SUBJECT STENT RETRIEVER OUT BY PUTTING ANOTHER STENT RETRIEVER THROUGH BUT FAILED SO IT IS STILL IN THE PATIENTS CAROTID TOP. NO FURTHER INFORMATION IS AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE FOR CAROTID TOP OCCLUSION, WHEN THE PHYSICIAN TRIED TO RETRIEVE THE SUBJECT STENT RETRIEVER, THERE WAS RESISTANCE AND IT BROKE LOSE FROM THE PUSHERWIRE. AFTER THAT THE PHYSICIAN TRIED TO GET THE SUBJECT STENT RETRIEVER OUT BY PUTTING ANOTHER STENT RETRIEVER THROUGH BUT FAILED SO IT IS STILL IN THE PATIENTS CAROTID TOP. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H3 OTHER TEXT : THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.