TREVO NXT 6MM X 37MM - US

Additional Manufacturer Narrative

THE SUBJECT DEVICE IS NOT YET RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN AIS TREATMENT, THE SUBJECT RETRIEVER DETACHED FROM ITS DELIVERY WIRE UPON DEPLOYMENT. THE PHYSICIAN REMOVED THE FRAGMENT BY USING A SNARE. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS VERY MEANDERING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

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 DETACHED 8CM FROM THE MID SOLDER JOINT. THE PEBAX WAS STRETCHED AND CORE WIRE FRACTURED. THE RETRIEVER SHAPED SECTION WAS DAMAGED AND THERE WAS PROCEDURAL FLUID PRESEN. THE RETRIEVER CORE WIRE WAS BENT. THE PEBAX WAS DAMAGED AT THE MID SOLDER JOINT. FUNCTIONAL INSPECTION WAS NOT REQUIRED AS THE FRACTURE WAS CONFIRMED. AS PER SEM ANALYSIS BY RD, THE DELIVERY WIRE SEEMS TO HAVE A REALLY BAD BEND/KINK, WHICH CAUSES LOSS OF PUSHABILITY AND ULTIMATELY FRACTURE. FRACTOGRAPHY CONFIRMS DUCTILE FRACTURE AT KINK LOCATION. 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. IT WAS REPORTED THAT THE SUBJECT RETRIEVER GOT STUCK IN THE CATHETER AND THE STENT BROKE OFF DURING MANIPULATION INSIDE THE CATHETER. THE SUBJECT RETRIEVER WAS USED WITH A MICROCATHETER AND AN INTERMEDIATE CATHETER. THE SUBJECT RETRIEVER WAS RETURNED TOGETHER WITH PACKAGING CONTENTS AND ENTIRE DEVICE FRAGMENTS (PROXIMAL AND DISTAL). DURING ANALYSIS, THE CORE WIRE WAS FOUND TO BE BROKEN AND DETACHED FROM THE RETRIEVER SHAPED SECTION. THE RETRIEVER SHAPED SECTION WAS DETACHED 8CM FROM THE MID SOLDER JOINT REGION. THE STENT RETRIEVER PURPLE PEBAX SECTION WAS OBSERVED TO BE STRETCHED AND CORE WIRE FRACTURED. PER RD SEM ANALYSIS, THE DELIVERY WIRE SEEMS TO HAVE A REALLY BAD BEND/KINK, WHICH CAUSES LOSS OF PUSHABILITY AND ULTIMATELY FRACTURE. FRACTOGRAPHY CONFIRMS DUCTILE FRACTURE AT KINK LOCATION. THE AS REPORTED 'RETRIEVER FRACTURE/BROKEN DURING USE' WAS CONFIRMED AS THE SHAPED SECTION WAS RETURNED BROKEN. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT ANATOMY WAS "VERY MEANDERING", WHICH MAY HAVE CONTRIBUTED TO THE DAMAGE SEEN ON THE RETURNED DEVICE AND THE NOTED DEFECTS. IT IS PROBABLE THAT DURING THE USE OF THE RETURNED STENT RETRIEVER THERE WERE PROCEDURAL AND/OR ANATOMICAL FACTORS PRESENT DURING THE CLINICAL PROCEDURE WHICH CAUSED THE EVENT. THEREFORE, AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED 'RETRIEVER FRACTURE/BROKEN DURING USE' AND AS ANALYZED 'RETRIEVER CORE WIRE BROKEN DURING USE', 'RETRIEVER DELIVERY WIRE LAMINATION DAMAGE/PEELING', 'RETRIEVER SHAPED SECTION DAMAGE', AND 'RETRIEVER CORE WIRE KINKED' SINCE THESE ISSUES ARE 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 AN AIS TREATMENT, THE SUBJECT RETRIEVER DETACHED FROM ITS DELIVERY WIRE UPON DEPLOYMENT. THE PHYSICIAN REMOVED THE FRAGMENT BY USING A SNARE. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS VERY MEANDERING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.