TREVO NXT 6MM X 37MM - US

Additional Manufacturer Narrative

BASED ON THE RESULTS OF THE DHR REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. DURING THE VISUAL/ MICROSCOPIC INSPECTION, THE RETRIEVER WAS RETURNED DETACHED. THE RETRIEVER SHAPED SECTION WAS FLATTENED. THE RETRIEVER WAS FRACTURED AT THE CORE WIRE. THE INSERTION TOOL WAS NOT RETURNED. THE POLYMER JACKET IS SHOWN TO HAVE SLIGHT DEFORMATION NOTED, THERE IS A BEND ON CORE WIRE JUST PROXIMAL TO FRACTURE SITE. FUNCTIONAL TESTING WAS NOT REQUIRED AS THE CORE WIRE WAS FRACTURED. 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. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE. BASED ON THE INFORMATION PROVIDED, IT IS MOST LIKELY THAT THE STENT RETRIEVER BECAME DETACHED FROM THE DEVICE DURING CLEANING OF THE DEVICE AFTER THE FIRST PASS. AN ASSIGNABLE CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THE AS REPORTED (AR) DEFECT OF "RETRIEVER FRACTURE/BROKEN DURING USE" AND AS ANALYSED (AA) DEFECTS OF "RETRIEVER CORE WIRE BROKEN DURING PREPARATION" AND "RETRIEVER SHAPED SECTION DAMAGE", BECAUSE THIS COMPLAINT APPEARS TO BE ASSOCIATED WITH HANDLING OF THE PRODUCT OR PORTION OF THE PRODUCT PREPARATION OF THE PRODUCT PRIOR TO USE, A PROBABLE CAUSE OF HANDLING DAMAGE WAS ASSIGNED.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE ACUTE ISCHEMIC STROKE TREATMENT PROCEDURE, THE PHYSICIAN USED THE SUBJECT STENT TO COLLECT THE THROMBUS AT THE MIDDLE CEREBRAL ARTERY (MCA). THE TECHNOLOGIST PUSHED THE DEVICE OUT OF THE CATHETER AFTER THE FIRST PASS AND THE STENT WAS CLEANED AND PLACED UNDER THE TOWEL. THE TECHNOLOGIST DIDN'T NOTICE THE STENT WAS DETACHED FROM THE WIRE UNTIL LATER. THE PHYSICIAN DOESN¿T RECALL WHEN THE DETACHMENT OCCURRED. THE PHYSICIAN DID NOT ATTEMPT TO REUSE THE DEVICE ONCE THEY NOTICED THE FRACTURE OF THE STENT. THE PHYSICIAN ABORTED THE PROCEDURE, BUT NOT DUE TO THE STENT DETACHING. IT WAS ALSO REPORTED THAT THE PATIENT'S ANATOMY WAS NORMALLY TORTUROUS. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE ACUTE ISCHEMIC STROKE TREATMENT PROCEDURE, THE PHYSICIAN USED THE SUBJECT STENT TO COLLECT THE THROMBUS AT THE MIDDLE CEREBRAL ARTERY (MCA). THE TECHNOLOGIST PUSHED THE DEVICE OUT OF THE CATHETER AFTER THE FIRST PASS AND THE STENT WAS CLEANED AND PLACED UNDER THE TOWEL. THE TECHNOLOGIST DIDN'T NOTICE THE STENT WAS DETACHED FROM THE WIRE UNTIL LATER. THE PHYSICIAN DOESN¿T RECALL WHEN THE DETACHMENT OCCURRED. THE PHYSICIAN DID NOT ATTEMPT TO REUSE THE DEVICE ONCE THEY NOTICED THE FRACTURE OF THE STENT. THE PHYSICIAN ABORTED THE PROCEDURE, BUT NOT DUE TO THE STENT DETACHING. IT WAS ALSO REPORTED THAT THE PATIENT'S ANATOMY WAS NORMALLY TORTUROUS. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.