TREVO NXT 3MM X 32MM - CE

Additional Manufacturer Narrative

H4: MANUFACTURING DATE: ADDED. D4: EXPIRATION DATE: ADDED. 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 RISK OF 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. IT WAS REPORTED THAT DURING A CLINICAL STUDY, A SERIOUS ADVERSE EVENT OCCURRED: CARDIAC DECOMPENSATION, HEMORRHAGIC REMODELING PARENCHYMAL HEMATOMA PH1 WITHOUT MASS EFFECT, WITHOUT COMMITMENT. THE GOOD FAITH EFFORT ATTEMPTS HAVE BEEN COMPLETED IN OUR EFFORT TO OBTAIN ANSWERS TO FOLLOW UP QUESTIONS. HOWEVER, AS OF TODAY, NO RESPONSE HAS BEEN RECEIVED. AS A PRODUCT RELATED ROOT CAUSE DOES NOT APPLY AND THE ISSUE IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND/OR PATIENT CONDITION NOTED WITH THE DIRECTIONS FOR USE, PRODUCT LABELING AND/OR RISK DOCUMENTATION FILES, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION, WILL BE ASSIGNED TO THIS COMPLAINT.

Description of Event or Problem

IT WAS REPORTED THAT AFTER AN ENDOVASCULAR PROCEDURE IN A PATIENT USING THE SUBJECT DEVICE, THERE WAS CARDIAC DECOMPENSATION, HEMORRHAGIC REMODELING PH1 (PARENCHYMAL HEMATOMA 1) WITHOUT MASS EFFECT, WITHOUT COMMITMENT. INITIAL SYMPTOMS INCLUDED ACUTE PULMONARY EDEMA, DETERIORATION OF RENAL FUNCTION, DISTURBANCES OF ALERTNESS. LEFT LOWER EXTREMITY PLEGIA (SIDE 4 ON THE NIHSS NATIONAL INSTITUTE OF HEALTH STROKE SCALE), ALERTNESS DISORDERS. PATIENT RECOVERED ON (B)(6) 2023. NO OTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

]THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

Description of Event or Problem

IT WAS REPORTED THAT AFTER AN ENDOVASCULAR PROCEDURE IN A PATIENT USING THE SUBJECT DEVICE, THERE WAS CARDIAC DECOMPENSATION, HEMORRHAGIC REMODELING PH1 (PARENCHYMAL HEMATOMA 1) WITHOUT MASS EFFECT, WITHOUT COMMITMENT. INITIAL SYMPTOMS INCLUDED ACUTE PULMONARY EDEMA, DETERIORATION OF RENAL FUNCTION, DISTURBANCES OF ALERTNESS. LEFT LOWER EXTREMITY PLEGIA (SIDE 4 ON THE NIHSS NATIONAL INSTITUTE OF HEALTH STROKE SCALE), ALERTNESS DISORDERS. PATIENT RECOVERED ON (B)(6) 2023. NO OTHER INFORMATION IS AVAILABLE.