TREVO NXT 4MM X 41MM - US

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE DEVICE WAS RETURNED FOR ANALYSIS. DURING VISUAL INSPECTION, THE CORE WIRE WAS SEEN TO BE KINKED/BEND APPROX. 142 CM FROM THE PROXIMAL END. THE CORE WIRE WAS SEEN TO BE BROKEN AT THE DISTAL END OF THE DEVICE, APPROX.194CM FROM THE PROXIMAL END. THE RETRIEVER SHAPED SECTION AND THE INSERTION TOOL WERE NOT RETURNED. SEM (SCANNING ELECTRON MICROSCOPY) WAS PERFORMED ON THE FRACTURE. THERE WERE DIMPLES AND VOIDS ON FRACTURE SURFACE. THERE WAS A BEND ANGLE IN THE FRACTURE WIRE. THERE WAS NARROWING AND NECKING IN THE WIRE LEADING UP TO FRACTURE SURFACE. SAMPLING HANDLING DEFECT WAS VISIBLE. 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 COMPLAINT WAS CONFIRMED BASED ON ANALYSIS. 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 THE RETRIEVER BROKE OFF IN THE PATIENT'S MCA AND WAS LEFT IN THE PATIENT'S ANATOMY. 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 CORE WIRE COMPONENT OF THE DEVICE WAS RETURNED FOR INVESTIGATION, AND THE CORE WIRE WAS SEEN TO BE KINKED/BEND AND BROKEN AT THE DISTAL END. THE RETRIEVER SHAPED SECTION AND INSERTION TOOL WERE NOT RETURNED. SEM IMAGING WAS PERFORMED ON THE FRACTURE POINT WHICH SHOWED BENDING AT THE FRACTURE POINT WITH EVIDENCE OF DUCTILE OVERLOAD FAILURE UNDER BENDING LOAD. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED AND ANALYZED EVENTS OF RETRIEVER FRACTURE/BROKEN DURING USE, UN-RETRIEVED DEVICE FRAGMENTS, RETRIEVER CORE WIRE KINKED AND RETRIEVER CORE WIRE BROKEN DURING USE SINCE THESE ISSUES APPEAR TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT RETRIEVER (SUBJECT DEVICE) BROKE OFF IN THE PATIENT. THE RETRIEVER WAS UNABLE TO BE REMOVED AND REMAINS IN THE PATIENT. THERE WAS AN UNKNOWN SURGICAL DELAY AS A RESULT OF THE EVENT. LIFELONG ANTIPLATELET MEDICATIONS ARE LIKELY REQUIRED AS A RESULT OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT RETRIEVER (SUBJECT DEVICE) BROKE OFF IN THE PATIENT. THE RETRIEVER WAS UNABLE TO BE REMOVED AND REMAINS IN THE PATIENT. THERE WAS AN UNKNOWN SURGICAL DELAY AS A RESULT OF THE EVENT. LIFELONG ANTIPLATELET MEDICATIONS ARE LIKELY REQUIRED AS A RESULT OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.