TREVO NXT 6MM X 37MM - CE

Description of Event or Problem

IT WAS REPORTED THAT DURING THROMBECTOMY PROCEDURE AS PART OF ACUTE STROKE PROCEDURE, THE OPERATOR USED THE SUBJECT STENT RETRIEVER TOGETHER WITH AN ASPIRATION CATHETER. THE ANATOMY WAS TORTUOUS AND THE OPERATOR HAD DIFFICULTIES BRINGING THE ASPIRATION CATHETER UP, SO IT WAS DECIDED TO PULL THE ENTIRE SYSTEM OUT. HOWEVER, AFTER CHECKING THE RESULTS OF THE FIRST PASS, IT WAS NOTICED THAT THE SUBJECT STENT RETRIEVER WAS STILL IN PLACE. THE SUBJECT DEVICE RIPPED OF AT THE DISTAL POINT OF THE PUSHER WIRE. THE SUBJECT STENT WAS FULLY APPOSED AGAINST THE VESSEL WALL SO IT WAS DECIDED TO STOP THE THROMBECTOMY. THE SUBJECT STENT RETRIEVER REMAINS INTRACRANIALLY IN THE FRONTAL M2 BRANCH OF THE MIDDLE CEREBRAL ARTERY AS FAR AS THE CAVERNOUS SECTION OF THE LEFT INTERNAL CAROTID ARTERY; AND PART OF THE WIRE REMAINS IN THE INTERNAL CAROTID ARTERY. THROMBOCYTE AGGREGATION INHIBITION WITH TIROFIBAN WAS INITIATED THERAPEUTICALLY; WITH SUBSEQUENT SWITCH TO ACETYLSALICYLIC ACID AND CLOPIDOGREL; LIFELONG MEDICATION (IN A MODIFIED FORM) NECESSARY. THE PATIENT IS IN A GOOD CONDITION AND HAD NO FURTHER INFARCT.

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. VISUAL AND FUNCTIONAL INSPECTIONS WERE NOT PERFORMED DUE TO THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. 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 WAS UNABLE TO BE CONFIRMED AND IT CANNOT BE CONFIRMED THAT THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. THE DEVICE FAILED TO MEET SPECIFICATION WHEN RECEIVED, BASED ON THE DAMAGE NOTED. IT WAS REPORTED THAT AFTER DELIVERING EVERYTHING (THE ANATOMY WAS TORTUOUS AND THE OPERATOR HAD DIFFICULTIES BRINGING THE ASPIRATION CATHETER UP), THE OPERATOR WANTED TO PULL OUT THE SYSTEM TOGETHER IN ONE. WHEN CHECKING THE RESULTS OF THE FIRST PASS, THE OPERATOR NOTICED, THAT THE STENT RETRIEVER WAS STILL IN PLACE. THE DEVICE RIPPED OF AT THE DISTAL POINT OF THE PUSHER WIRE. LUCKILY, THE STENT WAS FULLY OPEN AND HAD GOOD WALL APPOSITION. THE OPERATOR DECIDED TO STOP THE THROMBECTOMY, GAVE SOME ANTICOAGULATION AND OBSERVED THE PATIENT VERY WELL. AS PER THE ADDITIONAL INFORMATION, THE DEVICE WAS PREPARED FOR USE AS PER THE DIRECTIONS FOR USE, THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE AND THE PATIENT¿S ANATOMY WAS SEVERELY TORTUOUS. AFTER STENT RETRIEVER PLACEMENT, THE PHYSICIAN WANTED TO BRING UP THE ASPIRATION CATHETER MORE, SO SHE PULLED ON THE STENT RETRIEVER WIRE AND PUSHED UP THE ASPIRATION CATHETER. THE ASPIRATION CATHETER DID NOT MOVE AT ALL, SO SHE LEFT IT THERE AND PROCEEDED WITH THE INTERVENTION. IT WAS MENTIONED THAT THE PATIENT¿S ANATOMY WAS SEVERELY TORTUOUS AND THERE WAS DIFFICULTY TO ADVANCE THE ASPIRATION CATHETER, DURING THE ATTEMPT TO ADVANCE THE ASPIRATION CATHETER THE STENT RETRIEVER WIRE WAS PULLED WHILE THE ASPIRATION CATHETER WAS PUSHED, IT IS LIKELY THAT THIS ACTION MAY HAVE CAUSED THE RETRIEVER CORE WIRE TO FRACTURE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED EVENTS: RETRIEVER CORE WIRE BROKEN DURING USE AND UN-RETRIEVED DEVICE FRAGMENTS, 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 THROMBECTOMY PROCEDURE AS PART OF ACUTE STROKE PROCEDURE, THE OPERATOR USED THE SUBJECT STENT RETRIEVER TOGETHER WITH AN ASPIRATION CATHETER. THE ANATOMY WAS TORTUOUS AND THE OPERATOR HAD DIFFICULTIES BRINGING THE ASPIRATION CATHETER UP, SO IT WAS DECIDED TO PULL THE ENTIRE SYSTEM OUT. HOWEVER, AFTER CHECKING THE RESULTS OF THE FIRST PASS, IT WAS NOTICED THAT THE SUBJECT STENT RETRIEVER WAS STILL IN PLACE. THE SUBJECT DEVICE RIPPED OF AT THE DISTAL POINT OF THE PUSHER WIRE. THE SUBJECT STENT WAS FULLY APPOSED AGAINST THE VESSEL WALL SO IT WAS DECIDED TO STOP THE THROMBECTOMY. THE SUBJECT STENT RETRIEVER REMAINS INTRACRANIALLY IN THE FRONTAL M2 BRANCH OF THE MIDDLE CEREBRAL ARTERY AS FAR AS THE CAVERNOUS SECTION OF THE LEFT INTERNAL CAROTID ARTERY; AND PART OF THE WIRE REMAINS IN THE INTERNAL CAROTID ARTERY. THROMBOCYTE AGGREGATION INHIBITION WITH TIROFIBAN WAS INITIATED THERAPEUTICALLY; WITH SUBSEQUENT SWITCH TO ACETYLSALICYLIC ACID AND CLOPIDOGREL; LIFELONG MEDICATION (IN A MODIFIED FORM) NECESSARY. THE PATIENT IS IN A GOOD CONDITION AND HAD NO FURTHER INFARCT.