TREVO NXT 4MM X 41MM - US

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, VISUAL TESTING AS WELL AS FUNCTIONAL TESTING CANNOT BE PERFORMED. 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 COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT AND WAS PREPARED FOR USE AS PER THE DFU, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE, THE ISSUE OCCURRED IN THE LEFT MCA WHEN RETRIEVING THE THROMBUS, THERE WAS NO DAMAGE NOTED TO THE MICROCATHETER OR INSERTION TOOL PRIOR TO USE, THE INSERTION TOOL WAS CORRECTLY SEATED IN THE MICROCATHETER HUB, 2 RETRIEVAL ATTEMPTS WERE MADE WITH THE SUBJECT RETRIEVER, AND THE RETRIEVER PASSED THROUGH STENTED ARTERIES. BASED ON THE INFORMATION PROVIDED, IT IS POSSIBLE THE RETRIEVER MAY HAVE GOTTEN CAUGHT ON A STENTED ARTERY AND THEN FRACTURED DURING MANIPULATION TO RETRIEVE IT. HOWEVER, THIS COULD NOT BE DEFINITIVELY DETERMINED AS IT IS UNKNOWN WHETHER ANY RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE. WHILE THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED ISSUE, BECAUSE REVIEW OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WAS ASSIGNED TO THIS COMPLAINT.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE FOR LEFT MCA MIDDLE CEREBRAL ARTERY ACUTE CEREBRAL INFARCTION, SUBJECT RETRIEVER PASSED THROUGH ANY STENTED ARTERIES AND 2 RETRIEVAL ATTEMPTS WERE MADE. WHILE RETRIEVING THE THROMBUS THE CORE WIRE OF THE SUBJECT STENT RETRIEVER WAS BROKEN OFF FROM THE DELIVERY WIRE IN THE PATIENT'S BODY. THE BROKEN FRAGMENT REMAINS IN PLACE WITHOUT RETRIEVAL. UNKNOWN MEDICATION IS ADDED. THE PATIENT IS CURRENTLY IN HOSPITAL, HEALTH CONDITION IS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE FOR LEFT MCA MIDDLE CEREBRAL ARTERY ACUTE CEREBRAL INFARCTION, SUBJECT RETRIEVER PASSED THROUGH ANY STENTED ARTERIES AND 2 RETRIEVAL ATTEMPTS WERE MADE. WHILE RETRIEVING THE THROMBUS THE CORE WIRE OF THE SUBJECT STENT RETRIEVER WAS BROKEN OFF FROM THE DELIVERY WIRE IN THE PATIENT'S BODY. THE BROKEN FRAGMENT REMAINS IN PLACE WITHOUT RETRIEVAL. UNKNOWN MEDICATION IS ADDED. THE PATIENT IS CURRENTLY IN HOSPITAL, HEALTH CONDITION IS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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