TREVO NXT 3MM X 32MM - CE

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, THE DISTAL END OF THE STENT RETRIEVER (SUBJECT DEVICE), ONE OF THE STRUTS HAS COME LOOSE AND IS HANGING BY A "THREAD". THE RETRIEVER (SUBJECT DEVICE) FORMED SECTION IS DAMAGED. ADDITIONALLY, THE RETRIEVER (SUBJECT DEVICE) WAS BROKEN/FRACTURED PRESUMABLY DURING RETRIEVAL. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE. THE DETACHED RETRIEVER (SUBJECT DEVICE) WAS RESTORED BY UNKNOWN MEDICAL INTERVENTION. IT WAS REPORTED THAT THE PATIENT'S GENERAL CONDITION WAS SEVERELY REDUCED, THEY WERE INTUBATED FOR THROMBECTOMY UNDER ANESTHESIOLOGICAL MONITORING, HAD HIGH-GRADE RIGHT HEMIPARESIS AND APHASIA WITH CAROTID T OCCLUSION AND NIHSS 7 POINTS. BUT, IT WAS UNKNOWN IF THE PATIENT'S GENERAL CONDITION WAS PRE PROCEDURE OR POST PROCEDURE. NO OTHER INFORMATION IS CURRENTLY AVAILABLE.

Additional Manufacturer Narrative

H4 MANUFACTURING DATE ¿ ADDED. H3 DEVICE EVALUATED BY MFG ¿UPDATED. H3 SUMMARY ATTACHED - UPDATED. D4 EXPIRATION DATE - ADDED. D4 LOT # - CORRECTED FROM UNKNOWN TO 0000052301. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE RETRIEVER SHAPED SECTION WAS INTACT, THE CORE WIRE WAS INTACT, THE INSERTION TOOL WAS NOT RETURNED AND THERE WAS DRIED PROCEDURAL FLUID ON THE SHAPED SECTION. A FUNCTIONAL TEST WAS NOT REQUIRED. THE REPORTED WAS NOT CONFIRMED DURING THE DEVICE ANALYSIS, THE DEVICE MET SPECIFICATIONS WHEN RETURNED FOR ANALYSIS. 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. IT WAS REPORTED THAT THE STENT RETRIEVER WAS FULLY RETRIEVED BY MEDICAL INTERVENTION. BASED UPON MEDICAL REVIEW, THE HARM OBSERVED IN THE COMPLAINT IS ANTICIPATED IN NATURE AS PER THE DEVICE RISK ASSESSMENT. THE DEVICE WAS RETURNED, AND A REVIEW OF ANALYSIS AND ALL AVAILABLE INFORMATION FAILS TO INDICATE AN ASSIGNABLE CAUSE OR PROBABLE ASSIGNABLE CAUSE FOR THE REPORTED EVENT, AN ASSIGNABLE CAUSE OF NOT CONFIRMED WILL BE ASSIGNED TO THIS COMPLAINT. NO ISSUE WAS NOTED WITH THE RETURNED RETRIEVER.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, THE DISTAL END OF THE STENT RETRIEVER (SUBJECT DEVICE), ONE OF THE STRUTS HAS COME LOOSE AND IS HANGING BY A "THREAD". THE RETRIEVER (SUBJECT DEVICE) FORMED SECTION IS DAMAGED. ADDITIONALLY, THE RETRIEVER (SUBJECT DEVICE) WAS BROKEN/FRACTURED PRESUMABLY DURING RETRIEVAL. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE. THE DETACHED RETRIEVER (SUBJECT DEVICE) WAS RESTORED BY UNKNOWN MEDICAL INTERVENTION. IT WAS REPORTED THAT THE PATIENT'S GENERAL CONDITION WAS SEVERELY REDUCED, THEY WERE INTUBATED FOR THROMBECTOMY UNDER ANESTHESIOLOGICAL MONITORING, HAD HIGH-GRADE RIGHT HEMIPARESIS AND APHASIA WITH CAROTID T OCCLUSION AND NIHSS 7 POINTS. BUT, IT WAS UNKNOWN IF THE PATIENT'S GENERAL CONDITION WAS PRE PROCEDURE OR POST PROCEDURE. NO OTHER INFORMATION IS CURRENTLY AVAILABLE.