TREVO NXT 6MM X 37MM - US

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE THERE WAS RESISTANCE WHEN THE SUBJECT STENT RETRIEVER WAS RETRACTED THROUGH MICROCATHETER AFTER A PASS WAS ATTEMPTED AND SUBJECT RETRIEVER CORE WIRE BROKE OFF. THE BROKEN FRAGMENT OF THE SUBJECT DEVICE WAS REMOVED FROM PATIENT VASCULATURE. THE PATIENT DIED NOT BECAUSE OF THIS REPORTED EVENT BUT BECAUSE SHE WENT FROM A TICI ZERO TO A TICI ZERO BECAUSE PHYSICIAN COULD GAIN ACCESS TO CLOT TO REMOVE IT DUE TO SEVERE VESSEL TORTUOSITY. NO OTHER INFORMATION IS AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE THERE WAS RESISTANCE WHEN THE SUBJECT STENT RETRIEVER WAS RETRACTED THROUGH MICROCATHETER AFTER A PASS WAS ATTEMPTED AND SUBJECT RETRIEVER CORE WIRE BROKE OFF. THE BROKEN FRAGMENT OF THE SUBJECT DEVICE WAS REMOVED FROM PATIENT VASCULATURE. THE PATIENT DIED NOT BECAUSE OF THIS REPORTED EVENT BUT BECAUSE SHE WENT FROM A TICI ZERO TO A TICI ZERO BECAUSE PHYSICIAN COULD GAIN ACCESS TO CLOT TO REMOVE IT DUE TO SEVERE VESSEL TORTUOSITY. NO OTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE RETRIEVER CORE WIRE WAS BROKEN/FRACTURED AT 7CM FROM THE DISTAL END OF THE CORE WIRE WITH STRETCHING NOTED TO THE PEBAX JACKET. THERE WAS SIGNIFICANT DAMAGE/BENDING AND KINKING NOTED TO THE DISTAL FRACTURED SECTION OF THE CORE WIRE. THERE WAS NO DAMAGE NOTED TO THE RETRIEVER SHAPED SECTION. DURING FUNCTIONAL TEST, THE RETRIEVER WAS NOT ATTEMPTED TO BE ADVANCED INTO A DEMO MICROCATHETER, AS THE RETRIEVER CORE WIRE 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 REPORTED RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT COULD NOT BE DUPLICATED DURING DEVICE ANALYSIS; HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE DEVICE FAILED TO MEET SPECIFICATION WHEN RECEIVED, BASED ON THE DAMAGE NOTED. IT WAS REPORTED THAT THE TREVO BROKE OFF WHEN IT WAS RETRACTED THROUGH MICROCATHETER. AS PER THE ADDITIONAL INFORMATION, THERE WAS FRICTION AND WIRE WAS PULLED OUT WITHOUT A TREVO ATTACHED, THE PATIENT'S ANATOMY WAS VERY TORTUOUS, RESISTANCE WAS ENCOUNTERED UPON PULLING TREVO OUT OF MICROCATHETER MC, THE RETRIEVER WAS BROKEN SEVERAL INCHES BEHIND THE TREVO ON THE WIRE, THE STENT FRACTURE OCCURRED WHILE PULLING THE TREVO OUT OF MC AFTER A PASS WAS ATTEMPTED AND RESISTANCE WAS EXPERIENCED DURING RETRACTION OF THE RETRIEVER. THE DEVICE WAS RETURNED, AND IT WAS CONFIRMED THAT THE DISTAL 7CM SECTION OF THE CORE WIRE WITH THE RETRIEVER SHAPED SECTION ATTACHED, HAD BEEN FRACTURED FROM THE CORE WIRE, THERE WAS SIGNIFICANT DAMAGE NOTED TO THE SEPARATED SECTION OF THE CORE WIRE. IT IS PROBABLE THAT THE PATIENT'S ANATOMY/ PROCEDURAL FACTORS CAUSED THE REPORTED FRICTION DURING THE ATTEMPT TO REMOVE THE RETRIEVER AS IS EVIDENT FROM THE DAMAGE NOTED TO THE RETURNED DEVICE AND CAUSING THE DEVICE TO FRACTURE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED 'RETRIEVER CORE WIRE BROKEN DURING USE' AND 'RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT' AND TO THE ANALYZED 'RETRIEVER CORE WIRE BROKEN/FRACTURED DURING USE' AND 'RETRIEVER CORE WIRE KINKED', 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.