TREVO NXT 6MM X 37MM - US

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION THE RETRIEVER WAS RETURNED WITH A SNARE DEVICE. THE CORE WIRE WAS SEEN TO BE KINKED. THE RETRIEVER SHAPED SECTION WAS SEEN TO BE INTACT. THE CORE WIRE WAS SEEN TO BE BROKEN AT THE DISTAL END OF THE DEVICE, WITH TWO BREAK POINTS IDENTIFIED: THE FIRST APPROXIMATELY 8CM FROM THE DISTAL END AND THE SECOND ONE APPROXIMATELY 10CM FROM THE DISTAL END. THE POLYMER JACKET WAS REMOVED, AND THE BREAK POINTS WERE IMAGED. 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 DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THERE WAS AN ISSUE WITH THE STENT RETRIEVER DURING A MEDICAL PROCEDURE. THE STENT RETRIEVER BROKE OFF INSIDE THE PATIENT AND IT HAD TO BE SNARED OUT. THAT THE DEVICE WAS PREPARED FOR USE AS PER THE DFU, 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. THE RETRIEVER AND APPROXIMATELY 10CM OF THE CORE WIRE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RECEIVED, DECONTAMINATED, INSPECTED, MEASURED, AND IMAGED. UPON REVIEW OF THE RETURNED DEVICE, IT WAS NOTED THAT THE CORE WIRE WAS KINKED AND THERE WAS TWO STRETCHING POINTS NOTED ON THE POLYMER JACKET AT THE DISTAL END, WHICH IS INDICATIVE THAT SOME STRESSES MAY HAVE BEEN EXERTED ON THE WIRE THAT COULD HAVE CONTRIBUTED TO THE FRACTURE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED AND ANALYSED EVENT ¿RETRIEVER CORE WIRE BROKEN DURING USE¿ AND ANALYSED EVENT ¿RETRIEVER CORE WIRE KINKED¿, AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS 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 THE RIGHT MCA M1 THROMBECTOMY PROCEDURE THE CORE WIRE OF THE STENT RETRIEVER (SUBJECT DEVICE) BROKE INSIDE THE PATIENT'S ANATOMY. THE OPERATOR USED A SNARE DEVICE TO REMOVE IT. PATIENT¿S ANATOMY WAS AVERAGE AND THERE WAS A SURGICAL DELAY OF 45-60 MIN. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT DURING THE RIGHT MCA M1 THROMBECTOMY PROCEDURE THE CORE WIRE OF THE STENT RETRIEVER (SUBJECT DEVICE) BROKE INSIDE THE PATIENT'S ANATOMY. THE OPERATOR USED A SNARE DEVICE TO REMOVE IT. PATIENT¿S ANATOMY WAS AVERAGE AND THERE WAS A SURGICAL DELAY OF 45-60 MIN. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.