TREVO NXT 6MM X 37MM - CE

Description of Event or Problem

IT WAS REPORTED THAT THE SUBJECT STENT RETRIEVER WAS TORN OFF THE DELIVERY WIRE DURING THE RETRACTION. SEVERAL STENT RETRIEVERS WERE USED TO TRY TO RECOVER THE TORN-OFF STENT RETRIEVER UNSUCCESSFULLY. A BALLOON WAS USED TO PINCH THE BROKEN STENT RETRIEVER ON THE CATHETER AND PULL IT OUT SUCCESSFULLY. A 180 MINUTES SURGICAL DELAY WAS REPORTED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

Description of Event or Problem

IT WAS REPORTED THAT THE SUBJECT STENT RETRIEVER WAS TORN OFF THE DELIVERY WIRE DURING THE RETRACTION. SEVERAL STENT RETRIEVERS WERE USED TO TRY TO RECOVER THE TORN-OFF STENT RETRIEVER UNSUCCESSFULLY. A BALLOON WAS USED TO PINCH THE BROKEN STENT RETRIEVER ON THE CATHETER AND PULL IT OUT SUCCESSFULLY. A 180 MINUTE SURGICAL DELAY WAS REPORTED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

Additional Manufacturer Narrative

DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION THE CORE WIRE WAS SEEN TO BE BROKEN AT THE DISTAL END OF THE DEVICE, APPROX. 194 CM FROM THE PROXIMAL END. THE RETRIEVER SHAPED SECTION WAS INTACT. THE INSERTION TOOL WAS NOT RETURNED. FUNCTIONAL INSPECTION WAS NOT REQUIRED. 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 ¿RETRIEVER FRACTURE/BROKEN DURING USE¿ WAS NOT CONFIRMED AS IT WAS THE RETRIEVER CORE WIRE THAT WAS FRACTURED; HOWEVER, IT IS LIKELY THAT IT WAS PERCEIVED THAT THE RETRIEVER WAS FRACTURED. THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE RETUNED DEVICE FAILED TO MEET SPECIFICATION WHEN RETURNED DUE TO THE DAMAGE NOTED TO THE DEVICE. IT WAS REPORTED THAT DURING THE SURGERY, THE STENT RETRIEVER WAS TORN OFF THE DELIVERY WIRE DURING RETRACTION. SEVERAL STENT RETRIEVERS WERE USED TO TRY TO RECOVER THE TORN-OFF STENT RETRIEVER. HOWEVER, THIS WAS UNSUCCESSFUL. IN THE END, A BALLOON WAS USED TO PINCH THE STENT RETRIEVER ON THE CATHETER AND PULL IT OUT SUCCESSFULLY. THE DEVICE WAS RETURNED AND IT WAS NOTED THAT THE RETRIEVER CORE WIRE HAD BEEN FRACTURED. RETRIEVAL OF THE RETRIEVER WITH INTEGRATED CLOT INTO THE CATHETER/ASPIRATION CATHETER MAY CAUSE RESISTANCE IF THE CLOT SIZE IS LARGER THAN THE INNER DIAMETER OF THE CATHETER, THEREFORE IT IS RECOMMENDED TO REMOVE THE RETRIEVER AND CATHETER AS A UNIT, WHILE THE RETRIEVER IS POSITIONED AT THE DISTAL END OF THE CATHETER TO PREVENT RETRIEVER DAMAGE. IT IS LIKELY THAT THERE MAY HAVE BEEN DIFFICULTIES ENCOUNTERED DURING RETRIEVAL OF THE RETRIEVER/ CLOT RESULTING IN THE FRACTURE TO THE CORE WIRE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED EVENT ¿RETRIEVER FRACTURED/BROKEN DURING USE¿ AND TO THE ANALYSED EVENT ¿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.