TREVO NXT 4MM X 41MM - CE

Description of Event or Problem

IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE SUBJECT STENT RETRIEVER WAS PLACED IN THE M1 TO RETRIEVE THE BLOOD CLOT. THE SUBJECT DEVICE DELIVERY WIRE WAS PULLED BACK INTO THE ASPIRATION CATHETER AND WHEN THE PHYSICIAN PULLED OUT THE DELIVERY WIRE, THERE WAS NO STENT ATTACHED. IT BECAME DISLODGED IN THE ASPIRATION CATHETER DURING RETRIEVAL. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF 5 MIN DUE TO THIS EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL/MICROSCOPIC INSPECTION, THE FRACTURED TREVO RETRIEVER SHAPED SECTION WAS RETURNED WITHIN THE DISTAL END OF A SIGNIFICANTLY DEFORMED MICROCATHETER (MC). THE CORE WIRE WAS CONFIRMED TO BE FRACTURED AT THE DISTAL END WITHIN THE PEBAX JACKED. THE DISTAL END OF THE RETRIEVER WAS EXTENDED FROM THE MC. THE RETRIEVER WAS REMOVED FROM THE MC AND THE PROXIMAL END OF THE RETRIEVER WAS NOTED TO BE SEVERELY DEFORMED. THE FRACTURE WAS CONFIRMED TO THE PROXIMAL END OF THE RETRIEVER/CORE WIRE. UNABLE TO PERFORM FUNCTIONAL TESTING AS THE RETRIEVER WAS FRACTURED. 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 WAS CONFIRMED. THE DEVICE FAILED TO MEET SPECIFICATION WHEN RECEIVED, BASED ON THE DAMAGE NOTED. IT WAS REPORTED THAT THE TREVO DELIVERY WIRE WAS PULLED BACK INTO THE ASPIRATION CATHETER AND WHEN THE PHYSICIAN PULLED OUT THE DELIVERY WIRE, THERE WAS NO STENT ATTACHED. IT BECAME DISLODGED IN THE ASPIRATION CATHETER DURING RETRIEVAL. AS PER THE ADDITIONAL INFORMATION, THE MICROCATHETER/ ASPIRATION CATHETER DISTAL END WAS NOT POSITIONED AT THE PROXIMAL END OF THE RETRIEVER AND WERE THE ASPIRATION CATHETER AND THE RETRIEVER POSITIONS MAINTAINED AND REMOVED AS A UNIT DURING THE RETRIEVAL ATTEMPT, THERE WAS AN ATTEMPT MADE TO WITHDRAW THE RETRIEVER WITH INTEGRATED CLOT BACK THROUGH THE ASPIRATION CATHETER. AS PER THE TREVO RETRIEVER IFU: IMMEDIATELY AFTER UNSHEATHING RETRIEVER, POSITION MICROCATHETER OR ASPIRATION CATHETER TIP MARKER OVER THE PROXIMAL SECTION OF THE RETRIEVER. MAINTAIN THIS POSITION DURING MANIPULATION AND WITHDRAWAL. IF RETRIEVER IS DIFFICULT TO WITHDRAW FROM THE VESSEL, DO NOT TORQUE RETRIEVER. ADVANCE MICROCATHETER OR ASPIRATION CATHETER OVER THE RETRIEVER AND REMOVE DEVICES AS A UNIT. IF UNDUE RESISTANCE IS MET WHEN WITHDRAWING THE RETRIEVER INTO THE MICROCATHETER, CONSIDER EXCHANGING FOR A LARGER DIAMETER ASPIRATION CATHETER. GENTLY WITHDRAW THE RETRIEVER AND LARGER DIAMETER CATHETER AS A UNIT. THE DEVICE WAS RETURNED, AND IT WAS CONFIRMED THAT THE RETRIEVER CORE WIRE WAS FRACTURED JUST PROXIMAL TO THE SHAPED SECTION (STENT) AND THERE WAS SEVERE DAMAGE NOTED TO THE SHAPED SECTION, THE ASPIRATION CATHETER WAS ALSO NOTED TO BE SIGNIFICANTLY DAMAGED. THE DAMAGE NOTED TO THE RETRIEVER SHAPED SECTION AND TO THE SOFIA CATHETER ARE INDICATIVE OF DIFFICULTY TO RETRACT THE RETRIEVER INTO THE CATHETER. IT IS LIKELY THAT THE RETRIEVER WITH INTEGRATED CLOT WERE PULLED BACK INTO THE ASPIRATION CATHETER, THE SIZE AND CONSISTENCY OF THE CLOT MAY HAVE CAUSED DIFFICULTY TO PULL THE RETRIEVER BACK INTO THE ASPIRATION CATHETER CAUSING THE REPORTED FRACTURE AND RETRIEVER DAMAGE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED AND ANALYZED RETRIEVER CORE WIRE BROKEN DURING USE AND THE ANALYZED RETRIEVER SHAPED SECTION DAMAGE, 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 THAT DURING A THROMBECTOMY PROCEDURE SUBJECT STENT RETRIEVER WAS PLACED IN THE M1 TO RETRIEVE THE BLOOD CLOT. THE SUBJECT DEVICE DELIVERY WIRE WAS PULLED BACK INTO THE ASPIRATION CATHETER AND WHEN THE PHYSICIAN PULLED OUT THE DELIVERY WIRE, THERE WAS NO STENT ATTACHED. IT BECAME DISLODGED IN THE ASPIRATION CATHETER DURING RETRIEVAL. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF 5 MIN DUE TO THIS EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.