TREVO NXT 3MM X 32MM - US

Description of Event or Problem

IT WAS REPORTED THAT DURING THE UNRUPTURED CEREBRAL ANEURYSM CASE, PHYSICIAN DEPLOYED THE SUBJECT STENT RETRIEVER INTO THE TORTUROUS VESSEL. THE SUBJECT STENT RETRIEVER COULD NOT BE USED AND WAS REMOVED FROM THE PATIENT'S ANATOMY. POST-PROCEDURE PATIENT WAS PRESENTED WITH SEVERE STROKE (SAH). PHYSICIAN THOUGHT THAT THE ADVERSE EVENT WAS DUE TO THE SUBJECT STENT RETRIEVER DEPLOYMENT. PATIENT WAS GIVEN ANTIHYPERTENSIVE AND HEMOSTATIC MEDICATIONS. ONE MONTH LATER, PATIENT WAS RECOVERED BUT HAD SEQUELAE. NO ADDITIONAL INFORMATION AVAILABLE

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, FUNCTIONAL TESTING AS WELL AS VISUAL 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. THE PATIENT HAD SEVERE VASCULAR TORTUOSITY, SO THE SUBJECT STENT RETRIEVER WAS DEPLOYED IN A VESSEL AND A CATHETER WAS ATTEMPTED TO BE GUIDED TO THE DISTAL VESSEL USING THE SUBJECT STET RETRIEVER AS A SUPPORT, BUT IT COULD NOT BE GUIDED AND IT WAS REMOVED. THE REPORTED 'PATIENT INTRACRANIAL HEMORRHAGE' IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND PATIENT CONDITION AND IS LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE. THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THIS EVENT.