TREVO NXT 6MM X 37MM - CE

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED DURING THE PROCEDURE FOR CAROTID TOP OCCLUSION, WHEN THE SUBJECT STENT RETRIEVER WAS USED TO ATTEMPT TO REMOVE A DETACHED/LOSE STENT IN THE PATIENTS ANATOMY, THE SUBJECT STENT WAS PARTIALLY BROKEN. NO OTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THIS IS 2/2 REPORT. H4 MANUFACTURING DATE ¿ ADDED. H3 DEVICE EVALUATED BY MFG ¿UPDATED. H3 SUMMARY ATTACHED - UPDATED. D4 EXPIRATION DATE - ADDED. D9 PRODUCT AVAILABLE TO STRYKER ¿ UPDATED. D9 RETURNED TO MANUFACTURER ON ¿UPDATED. D10 CONCOMITANT PRODUCT GRID - UPDATED. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL/MICROSCOPIC INSPECTION, THE RETRIEVER/CORE WIRE WAS RETURNED WITH A CATHETER. THE CORE WIRE WAS SEEN TO BE SEVERELY KINKED/BENT. THERE WAS DAMAGE NOTED TO THE RETRIEVER DELIVERY WIRE PEBAX /POLYMER LAYER. THERE WAS A BROKEN DISTAL PART OF THE CATHETER NOTED STUCK AT THE RETRIEVER CORE WIRE. THE RETRIEVER SHAPED SECTION WAS SEEN TO BE SLIGHTLY DAMAGED, NO FRACTURES WERE NOTED. THE INSERTION TOOL WAS NOT RETURNED. FUNCTIONAL INSPECTION COULD NOT BE CARRIED OUT DUE TO THE DAMAGE NOTED TO THE CORE WIRE. 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 EVENT OF DEVICE INTERACTION WITH ANOTHER DEVICE COULD NOT BE REPLICATED DURING DEVICE ANALYSIS; HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE REPORTED EVENT OF RETRIEVER FRACTURE/BROKEN DURING USE WAS NOT CONFIRMED DURING 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 CATHETER AND PLACED THE 1ST STENT RETRIEVER THROUGH THE CLOT. AFTER 5-MIN SHE TRIED TO RETRIEVE THE 1ST STENT RETRIEVER DEVICE BUT THE STENT BROKE LOSE FROM THE PUSHER WIRE. AFTER THAT THE PHYSICIAN TRIED TO GET THE 1ST STENT RETRIEVER OUT BY PUTTING A 2ND STENT RETRIEVER (SUBJECT DEVICE) THROUGH BUT THESE INTERACTED AND RESULTED IN A PARTIALLY BROKEN 2ND STENT RETRIEVER (SUBJECT DEVICE). AS PER THE ADDITIONAL INFORMATION, RESISTANCE WAS ENCOUNTERED WHEN THE PHYSICIAN WANTED TO RETRIEVE THE 1ST STENT RETRIEVER. WHEN SHE WANTED TO PULL BACK THE 1ST STENT RETRIEVER THE PHYSICIAN NEEDED TO PULL STRONG AND THEN IT BROKE LOOSE. RESISTANCE WAS EXPERIENCED DURING RETRACTION OF THE 1ST STENT RETRIEVER. THE 2ND STENT RETRIEVER (SUBJECT DEVICE) WAS RETURNED AND THE RETRIEVER CORE WIRE WAS NOTED TO BE EXTENSIVELY KINKED WITH DAMAGE TO THE PEBAX JACKET/POLYMER LAYER AND THE RETRIEVER SHAPED SECTION WAS NOTED TO BE SLIGHTLY DAMAGED. THERE WAS NO FRACTURES NOTED TO THE DEVICE. IT IS PROBABLE THAT THE RETRIEVER CORE WIRE WAS DAMAGED AND THE SHAPED SECTION WERE DAMAGED AS A RESULT OF THE ATTEMPT MADE TO RETRIEVER THE FRACTURED 1ST STENT RETRIEVER PREVIOUSLY FRACTURED WITHIN THE VESSEL. AN ASSIGNABLE CAUSE OF NOT CONFIRMED WILL BE ASSIGNED TO THE REPORTED RETRIEVER FRACTURE/BROKEN DURING USE, AS THERE WAS NO EVIDENCE OF FRACTURE TO THE RETURNED DEVICE. AN ASSIGNABLE CAUSE OF CAUSED BY OTHER WILL BE ASSIGNED TO THE REPORTED DEVICE INTERACTION WITH ANOTHER DEVICE, AND TO THE ANALYZED RETRIEVER CORE WIRE KINKED, RETRIEVER DELIVERY WIRE LAMINATION DAMAGE/PEELING AND RETRIEVER SHAPED SECTION DAMAGE, AS THIS DAMAGE OCCURRED AS A RESULT F THE ATTEMPT TO RETRIEVE THE DETACHED RETRIEVER SHAPED SECTION.

Description of Event or Problem

IT WAS REPORTED DURING THE PROCEDURE FOR CAROTID TOP OCCLUSION, WHEN THE SUBJECT STENT RETRIEVER WAS USED TO ATTEMPT TO REMOVE A DETACHED/LOSE STENT IN THE PATIENTS ANATOMY, THE SUBJECT STENT WAS PARTIALLY BROKEN. NO OTHER INFORMATION IS AVAILABLE.