TREVO NXT 6MM X 37MM - US

Description of Event or Problem

IT WAS REPORTED ON THE ATTACHED MEDWATCH REPORT# MW5159284 WHILE THE SUBJECT RETRIEVER STENT WAS BEING REMOVED FROM THE PATIENT, FLUOROSCOPY SHOWED THE RETRIEVER STENT HAD DETACHED INSIDE THE PATIENT'S VESSEL, SPANNING FROM THE RIGHT DISTAL M1 SEGMENT INTO THE CAROTID TERMINUS. THE PROXIMAL OF THE DEVICE REMAINED INSIDE THE CATHETER. THE PHYSICIAN TRIED EXTENSIVE EFFORTS TO REMOVE THE RETRIEVER, BUT IT COULD NOT BE EXTRACTED AND REMAINED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, VISUAL AND FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. 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 COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. IT WAS REPORTED THAT, THE RETRIEVER DEVICE DETACHED IN THE PATIENT DURING THE PROCEDURE. BASED ON THE INFORMATION PROVIDED IN THE COMPLAINT ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE BUT ATTEMPTS WERE UNSUCCESSFUL. THE STENT RETRIEVER REMAINED IN THE PATIENT. THERE WAS 3 1/2 HOURS SURGICAL DELAY, TRYING TO RECOVER THIS MALFUNCTIONING DEVICE. UNABLE TO RETRIEVE THE CATHETER. UNABLE TO RESTORE FLOW IN ALL AREAS. AS PER THE EVENT DESCRIPTION "THE TREVO DEVICE, WHICH IS NOT SUPPOSED TO FULLY DEPLOY, DID SO WHILE BEING REMOVED FROM THE VESSEL. THE MICROCATHETER WAS THEN TAKEN OUT EASILY, BUT INSTEAD OF THE GUIDEWIRE STAYING IN PLACE, IT REMAINED INSIDE THE MICROCATHETER. FLUOROSCOPY SHOWED THAT THE STENT HAD FULLY DETACHED INSIDE THE VESSEL, SPANNING FROM THE RIGHT DISTAL M1 INTO THE CAROTID TERMINUS. THE PROXIMAL PART OF THE DEVICE STAYED INSIDE THE HIPPO CATHETER. DESPITE EXTENSIVE EFFORTS, THE INTENSIVIST COULDN'T EXTRACT THE STENT". THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF ALL AVAILABLE INFORMATION FAILS TO IDENTIFY ANY POTENTIAL CAUSES FOR THE REPORTED EVENT, THEREFORE AN ASSIGNABLE CAUSE OF UNDERMINABLE WILL BE ASSIGNED TO THE REPORTED EVENT OF THE RETRIEVER FRACTURED/BROKEN DURING USE AND TO THE UN-RETRIEVED DEVICE FRAGMENTS.

Description of Event or Problem

IT WAS REPORTED ON THE ATTACHED MEDWATCH REPORT# MW5159284 WHILE THE SUBJECT RETRIEVER STENT WAS BEING REMOVED FROM THE PATIENT, FLUOROSCOPY SHOWED THE RETRIEVER STENT HAD DETACHED INSIDE THE PATIENT'S VESSEL, SPANNING FROM THE RIGHT DISTAL M1 SEGMENT INTO THE CAROTID TERMINUS. THE PROXIMAL OF THE DEVICE REMAINED INSIDE THE CATHETER. THE PHYSICIAN TRIED EXTENSIVE EFFORTS TO REMOVE THE RETRIEVER, BUT IT COULD NOT BE EXTRACTED AND REMAINED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.