TREVO NXT 6MM X 37MM - US

Additional Manufacturer Narrative

DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) 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. IT WAS REPORTED THAT THE DOCTOR REMOVED THE WIRE WITH THE STENT RETRIEVER, THE SUBJECT DEVICE BECOME DETACHED FROM THE WIRE. AS PER THE ADDITIONAL INFORMATION, THERE WAS A SURGICAL DELAY OF 10 MINUTES, THE STENT FRACTURE OCCURRED DURING RETRIEVAL. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AND A REVIEW OF ALL AVAILABLE INFORMATION FAILS TO INDICATE AN ASSIGNABLE CAUSE FOR THE REPORTED EVENT, THEREFORE AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THIS COMPLAINT.

Description of Event or Problem

IT WAS REPORTED THAT DURING LARGE VESSEL OCCLUSION LVO PROCEDURE, WHEN THE SUBJECT STENT RETRIEVER WAS RETRACTED, THE RETRIEVER BECAME DETACHED FROM THE WIRE. THERE WAS A SURGICAL DELAY OF 10MIN DUE TO THE REPORTED EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING LARGE VESSEL OCCLUSION LVO PROCEDURE, WHEN THE SUBJECT STENT RETRIEVER WAS RETRACTED, THE RETRIEVER BECAME DETACHED FROM THE WIRE. THERE WAS A SURGICAL DELAY OF 10MIN DUE TO THE REPORTED EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.