TREVO NXT 4MM X 41MM - CE

Additional Manufacturer Narrative

H4: MANUFACTURING DATE ¿ ADDED. D4: EXPIRATION DATE - ADDED. B5: EXECUTIVE SUMMARY ¿ UPDATED. F10 / H6: HEALTH EFFECT - CLINICAL CODE ¿ UPDATED. 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, 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 CANNOT BE CONFIRMED THAT THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. IT WAS REPORTED THAT A STENT RETRIEVER RUPTURED AND DETACHED AT THE A1-A2 ANGLE OF THE LEFT ANTERIOR CEREBRAL ARTERY, IN THE ABSENCE OF SIGNIFICANT RESISTANCE DURING DEVICE RETRACTION; ATTEMPTED STENT RETRIEVAL WITH A SECOND STENT RETRIEVER, FAILED. NO FURTHER INFORMATION WAS AVAILABLE. AS THE DEVICE WAS NOT RETURNED AND A REVIEW OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A CAUSE FOR THE REPORTED EVENT, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THE AS REPORTED ¿RETRIEVER FRACTURED/BROKEN DURING USE¿ AND ¿UN-RETRIEVED DEVICE FRAGMENTS.

Description of Event or Problem

DURING A MECHANICAL THROMBECTOMY PROCEDURE, WHILE RECANALIZING THE ANTERIOR CEREBRAL ARTERY IN A2-A3 TRACT THE SUBJECT STENT RETRIEVER WAS BROKEN AT THE A1-A2 ANGLE OF THE LEFT ANTERIOR CEREBRAL ARTERY. THE PHYSICIAN USED ANOTHER STENT RETRIEVER TO REMOVE THE BROKEN FRAGMENT OUT OF THE PATIENT ANATOMY. HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL AND THE BROKEN FRAGMENT WAS LEFT INSIDE THE PATIENT. THERE WAS IMPAIRMENT OF A BODILY FUNCTION NOTED TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

Description of Event or Problem

DURING A MECHANICAL THROMBECTOMY PROCEDURE, WHILE RECANALIZING THE ANTERIOR CEREBRAL ARTERY IN A2-A3 TRACT THE SUBJECT STENT RETRIEVER WAS BROKEN AT THE A1-A2 ANGLE OF THE LEFT ANTERIOR CEREBRAL ARTERY. THE PHYSICIAN USED ANOTHER STENT RETRIEVER TO REMOVE THE BROKEN FRAGMENT OUT OF THE PATIENT ANATOMY. HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL AND THE BROKEN FRAGMENT WAS LEFT INSIDE THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.