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 SHAPED SECTION WAS SEEN TO BE BROKEN/FRACTURED FROM THE CORE WIRE. THERE WAS APPROX. 8MM OF THE PEBAX JACKET EXPOSED. THE PEBAX WAS STRIPPED BACK TO EXAMINE THE CORE WIRE FRACTURE LOCATION. FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED AS THE RETRIEVER SHAPED SECTION WAS FRACTURED FROM THE CORE WIRE AND NOT RETURNED. 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 EVENTS CAN BE CONFIRMED BASED ON THE DEVICE ANALYSIS. THE DEVICE FAILED TO MEET SPECIFICATION, BASED ON THE DAMAGE NOTED TO THE DEVICE. IT WAS REPORTED THAT DURING THE THIRD PASS, THE SUBJECT STENT RETRIEVER WAS BROKEN BETWEEN THE STENT AND THE DISTAL TIP OF THE DELIVERY WIRE AND THE STENT PART WAS LEFT IN THE PATIENT'S BLOOD VESSEL. THE DOCTOR JUDGED THAT THE STENT PART COULD NOT BE REMOVED, AND THE PROCEDURE WAS TERMINATED WHILE THE STENT WAS LEFT IN THE BLOOD VESSEL. AS PER THE ADDITIONAL INFORMATION, THE FRICTION WAS EXPERIENCED WITHIN THE MICROCATHETER, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE AND THE PATIENTS ANATOMY WAS SEVERELY TORTUOUS. THE DEVICE WAS RETURNED AND THE CORE WIRE WAS NOTED TO BE FRACTURED. IT IS PROBABLE THAT THE PATIENTS SEVERELY TORTUOUS ANATOMY MAY HAVE CAUSED THE FRICTION REPORTED WITHIN THE MICROCATHETER AND CAUSING THE SUBSEQUENT FRACTURE TO THE RETRIEVER CORE WIRE. THEREFORE AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT, RETRIEVER FRACTURE/ BROKEN DURING USE AND UN-RETRIEVED DEVICE FRAGMENTS AND THE ANALYZED RETRIEVER CORE BROKEN DURING USE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE THIRD PASS OF THE THROMBECTOMY PROCEDURE, THERE WAS RESISTANCE WHILE USING THE SUBJECT STENT RETRIEVER WITH MICROCATHETER AND THE SUBJECT STENT RETRIEVER WAS BROKEN BETWEEN THE STENT AND THE DISTAL TIP OF THE DELIVERY WIRE AND THE STENT PART WAS LEFT IN THE PATIENT'S BLOOD VESSEL. THE DOCTOR JUDGED THAT THE STENT PART COULD NOT BE REMOVED, AND THE PROCEDURE WAS TERMINATED WHILE THE SUBJECT STENT RETRIEVER WAS LEFT IN THE BLOOD VESSEL. NO FURTHER INFORMATION IS AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE THIRD PASS OF THE THROMBECTOMY PROCEDURE, THERE WAS RESISTANCE WHILE USING THE SUBJECT STENT RETRIEVER WITH MICROCATHETER AND THE SUBJECT STENT RETRIEVER WAS BROKEN BETWEEN THE STENT AND THE DISTAL TIP OF THE DELIVERY WIRE AND THE STENT PART WAS LEFT IN THE PATIENT'S BLOOD VESSEL. THE DOCTOR JUDGED THAT THE STENT PART COULD NOT BE REMOVED, AND THE PROCEDURE WAS TERMINATED WHILE THE SUBJECT STENT RETRIEVER WAS LEFT IN THE BLOOD VESSEL. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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