TREVO NXT 4MM X 28MM - US

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE THE SUBJECT DEVICE RETRIEVER DETACHED OUT OF DELIVERY WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND ONE PASS TICI 3 WAS ACHIEVED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

Additional Manufacturer Narrative

BASED ON THE RESULTS OF THE DEVICE HISTORY RECORD (DHR) REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING, OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. DURING VISUAL INSPECTION, THE RETRIEVER WAS DETACHED FROM THE CORE WIRE, THE CORE WIRE WAS KINKED, AND THE RETRIEVER COILS WERE DAMAGED, THE RETRIEVER WAS DETACHED, THE CATHETER RETURNED WAS INTACT. A FUNCTIONAL TEST WAS UNABLE TO BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE REPORTED EVENT WAS CONFIRMED DURING THE DEVICE ANALYSIS. THE DEVICE FAILED TO MEET SPECIFICATION WHEN RETURNED BASED ON THE DAMAGE NOTED. 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 WAS RETURNED, AND IT WAS NOTED THAT THE RETRIEVER SHAPED SECTION HAD SEPARATED FROM THE CORE WIRE, DAMAGE WAS NOTED TO THE RETRIEVER. THERE WAS A MICROCATHETER RETURNED WITH THE DEVICE AND WAS FOUND TO BE INTACT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO PREPARATION OF THE DEVICE, THERE WERE NO ANOMALIES NOTED TO THE DEVICE AFTER REMOVAL FROM THE PACKAGING OR PRIOR TO PREPARATION, THE DEVICE WAS PREPARED AS PER THE DFU AND CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE. ALSO, THE ADDITIONAL INFORMATION INDICATED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS WHICH MAY HAVE CONTRIBUTED TO THE EVENT. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED 'RETRIEVER FRACTURE/BROKEN DURING USE' AND TO THE ANALYSED 'RETRIEVER CORE WIRE BROKEN DURING USE', ¿RETRIEVER CORE WIRE KINKED' AND 'RETRIEVER COILS DAMAGED', AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU 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 PROCEDURE THE SUBJECT DEVICE RETRIEVER DETACHED OUT OF DELIVERY WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND ONE PASS TICI 3 WAS ACHIEVED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.