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. VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS 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. ADDITIONAL INFORMATION RECEIVED INDICATES THAT NO DAMAGE NOTED TO THE PACKAGING, NO DAMAGE NOTED TO THE DEVICE PRIOR USE/DURING PREPARATION, THE DEVICE PREPARED AS PER THE DFU, THERE WAS TORQUEING OF THE STENT DURING PROCEDURE IN ATTEMPT TO RETRIEVE THE CLOT, AND NO PRE-IMPLANTED STENT PRESENT IN THE VASCULATURE. WHILE THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED ISSUE, BECAUSE REVIEW AND ANALYSIS OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE AND THE DEVICE WAS NOT RETURNED, AN ASSIGNABLE CAUSE OF 'UNDETERMINABLE' WAS ASSIGNED TO THIS COMPLAINT.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH AN ISCHEMIC STROKE IN THE M1/M2 REGION FROM ATRIAL FIBRILLATION. DURING THE PROCEDURE, THE PHYSICIAN STARTED WITH ASPIRATION AND THEN USED THE SUBJECT TREVO AS A BAILOUT THERAPY. AT THE FIRST RETRIEVAL ATTEMPT UPON PULLING OUT OF THE RETRIEVER, THE PHYSICIAN NOTICED RESISTANCE. THE PHYSICIAN APPRECIATED THE VESSEL STRETCHING SO HE ¿FLUFFED¿ THE DEVICE TO TAKE OUT WITH RESISTANCE AND WHEN HE PULLED THE DELIVERY WIRE, THE SUBJECT RETRIEVER BROKE AT THE JUNCTION OF THE DELIVERY WIRE AND STENT. THE PHYSICIAN TIED TO RETRIEVE THE BROKEN PART OF THE STENT WITH A SNARE DEVICE, DIRECT ASPIRATION AND TRIED TO SECURE THE STENT WITH AN EMBOTRAP DEVICE; HOWEVER, THE ATTEMPTS WERE NOT SUCCESSFUL. THE BROKEN PART OF THE SENT WAS LEFT INSIDE THE PATIENT IN THE M1/M2 REGION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE SUBJECT DEVICE NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH AN ISCHEMIC STROKE IN THE M1/M2 REGION FROM ATRIAL FIBRILLATION. DURING THE PROCEDURE, THE PHYSICIAN STARTED WITH ASPIRATION AND THEN USED THE SUBJECT TREVO AS A BAILOUT THERAPY. AT THE FIRST RETRIEVAL ATTEMPT UPON PULLING OUT OF THE RETRIEVER, THE PHYSICIAN NOTICED RESISTANCE. THE PHYSICIAN APPRECIATED THE VESSEL STRETCHING SO HE ¿FLUFFED¿ THE DEVICE TO TAKE OUT WITH RESISTANCE AND WHEN HE PULLED THE DELIVERY WIRE, THE SUBJECT RETRIEVER BROKE AT THE JUNCTION OF THE DELIVERY WIRE AND STENT. THE PHYSICIAN TIED TO RETRIEVE THE BROKEN PART OF THE STENT WITH A SNARE DEVICE, DIRECT ASPIRATION AND TRIED TO SECURE THE STENT WITH AN EMBOTRAP DEVICE; HOWEVER, THE ATTEMPTS WERE NOT SUCCESSFUL. THE BROKEN PART OF THE SENT WAS LEFT INSIDE THE PATIENT IN THE M1/M2 REGION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.