TREVO NXT 6MM X 37MM - US

Description of Event or Problem

IT WAS REPORTED THAT THE SUBJECT STENT RETRIEVER WAS DISCONNECT DURING THE PROCEDURE AND WAS LEFT INSIDE THE PATIENT. PHYSICIAN MADE ATTEMPTS TO RETRIEVE THE BROKEN PART BUT WAS UNSUCCESSFUL. THERE WAS A SURGICAL DELAY BUT THE DURATION IS NOT KNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

Additional Manufacturer Narrative

B2: OUTCOMES ATTRIBUTED TO AE: UPDATED. B5: EXECUTIVE SUMMARY : UPDATED. D10: CONCOMITANT PRODUCTS GRID : UPDATED. F10 / H6: HEALTH EFFECT - CLINICAL CODE: UPDATED. F10 / H6: HEALTH EFFECT - IMPACT CODE: UPDATED. D: SUSPECT MEDICAL DEVICE INFORMATION: UPDATED. D4: EXPIRATION DATE - ADDED. H4: MANUFACTURING DATE ¿ ADDED. 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. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PHYSICIAN REPORTED THE FACT THAT THERE WERE NO ANOMALIES WITH THE STENT PRIOR TO USE ON THE PATIENT AND EVERYTHING WAS PREPARED AS DESCRIBED IN DFU. THE SUBJECT RETRIEVER STENT BROKE AND THE BROKEN PIECE OF THE SUBJECT STENT COULD NOT BE REMOVED FROM PATIENT VASCULATURE. ALSO ADDITIONAL INFORMATION INDICATED THAT AN ATTEMPT WAS MADE TO RETRIEVE THE STENT WITH A SNARE. WHILE THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED ISSUE, BECAUSE REVIEW AND ANALYSIS OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE AND THE DEVICE WAS NOT RETURNED, AN ASSIGNABLE CAUSE OF 'UNDETERMINABLE' WILL BE ASSIGNED TO THE AS REPORTED RETRIEVER FRACTURE/BROKEN DURING USE', ' UN-RETRIEVED DEVICE FRAGMENTS AND 'RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT'. THE AS REPORTED 'PATIENT INTRACRANIAL HEMORRHAGE' WILL BE ASSIGNED 'ANTICIPATED PROCEDURAL COMPLICATIONS' AS THIS IS KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND/OR PATIENT CONDITION NOTED WITH THE DIRECTIONS FOR USE, PRODUCT LABELING AND/OR RISK DOCUMENTATION FILES.

Description of Event or Problem

IT WAS REPORTED THAT THE SUBJECT STENT RETRIEVER WAS DISCONNECT DURING THE PROCEDURE AND WAS LEFT INSIDE THE PATIENT. PHYSICIAN MADE ATTEMPTS TO RETRIEVE THE BROKEN PART BUT WAS UNSUCCESSFUL. THERE WAS A SURGICAL DELAY BUT THE DURATION IS NOT KNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A COMBINATION MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED FOR NIHSS 18 IN A PATIENT WITH INTRA CRANIAL ATHEROSCLEROTIC DISEASE IN THE RIGHT MIDDLE CEREBRAL ARTERY WITH CALCIFIED CLOT. DURING THE FIRST PASS MILD RESISTANCE WAS FELT IN THE PROXIMAL SUPRACLINOID WHILE ADVANCING THE SUBJECT RETRIEVER STENT AND WHEN ATTEMPTED TO RETRIEVE THE SUBJECT RETRIEVER STENT CORE WIRE BROKE. AN ATTEMPT WAS MADE TO RETRIEVE THE BROKEN SUBJECT RETRIEVER STENT USING A SNARE, BUT IT WAS NOT SUCCESSFUL AND THEREFORE THE SUBJECT RETRIEVER STENT WAS LEFT INSIDE THE PATIENT¿S VASCULAR ANATOMY (IN THE RIGHT MIDDLE CEREBRAL ARTERY). FOLLOW UP CT SCAN SHOWED SUBARACHNOID HEMORRHAGE WHICH WAS TREATED WITH MEDICAL MANAGEMENT. THE PROCEDURE COULD NOT BE COMPLETED, AND THE PATIENT WAS IN THE ICU (INTENSIVE CARE UNIT) ON A DAY WE RECEIVED THE INFORMATION.