TREVO NXT 4MM X 41MM - CE

Additional Manufacturer Narrative

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 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. 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. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PHYSICIAN REPORTED THE FACT THAT THERE WERE NO ANOMALIES WITH THE STENT AND THE STENT BOX BEFORE OPENING 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. WHILE THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED ISSUE OF RETRIEVER FRACTURE/BROKEN DURING USE, 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 THIS COMPLAINT.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE FOR STROKE TREATMENT, THE SUBJECT STENT BROKE INSIDE THE PATIENT¿S VASCULATURE. IT IS UNCLEAR IF THE PHYSICIAN REMOVED THE SUBJECT STENT FROM PATIENT VASCULATURE OR IF THE BROKEN PIECE WHICH WAS LEFT IN THE PATIENT. THE PATIENT'S CONDITION COULD NOT BE IMPROVED COMPARED TO BEFORE THE PROCEDURE AS VASCULAR PATENCY COULD NOT BE OBTAINED. PROCEDURE WAS NOT COMPLETED. PATIENT WAS STABLE AFTER THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 6-JAN-2022 STATED THAT MCA (MIDDLE CEREBRAL ARTERY) M1 SEGMENT MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED FOR STROKE TREATMENT ON THE HEMIPLEGIC PATIENT. WHILE RETRIEVER OF THE SUBJECT STENT AFTER TWO ATTEMPTS, IT BROKE INSIDE THE PATIENT¿S VASCULATURE. DOCTOR COULDN¿T BE ABLE TO RETRIEVE THE BROKEN PART AND THE BROKEN PIECE OF DEVICE REMAINED AT DISTAL ICA (INTERNAL CAROTID ARTERY) TO MCA (MIDDLE CEREBRAL ARTERY) M1 SEGMENT VASCULATURE. AS THE STENT BROKE, PROCEDURE WAS NOT COMPLETED AND ORIGINAL CLOT, WHICH WAS THE REASON FOR ISCHEMIC STROKE, WAS NOT ABLE TO RETRIEVE AND THEREFORE VASCULAR PATENCY COULD NOT BE OBTAINED. THE PATIENT'S CONDITION (HEMIPLEGIA NOTED BEFORE STENT RETRIEVER USAGE) COULD NOT BE IMPROVED COMPARED TO BEFORE THE PROCEDURE. PATIENT WAS STABLE AFTER THE PROCEDURE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE FOR STROKE TREATMENT, THE SUBJECT STENT BROKE INSIDE THE PATIENT¿S VASCULATURE. IT IS UNCLEAR IF THE PHYSICIAN REMOVED THE SUBJECT STENT FROM PATIENT VASCULATURE OR IF THE BROKEN PIECE WHICH WAS LEFT IN THE PATIENT. THE PATIENT'S CONDITION COULD NOT BE IMPROVED COMPARED TO BEFORE THE PROCEDURE AS VASCULAR PATENCY COULD NOT BE OBTAINED. PROCEDURE WAS NOT COMPLETED. PATIENT WAS STABLE AFTER THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 6-JAN-2022 STATED THAT MCA (MIDDLE CEREBRAL ARTERY) M1 SEGMENT MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED FOR STROKE TREATMENT ON THE HEMIPLEGIC PATIENT. WHILE RETRIEVER OF THE SUBJECT STENT AFTER TWO ATTEMPTS, IT BROKE INSIDE THE PATIENT¿S VASCULATURE. DOCTOR COULDN¿T BE ABLE TO RETRIEVE THE BROKEN PART AND THE BROKEN PIECE OF DEVICE REMAINED AT DISTAL ICA (INTERNAL CAROTID ARTERY) TO MCA (MIDDLE CEREBRAL ARTERY) M1 SEGMENT VASCULATURE. AS THE STENT BROKE, PROCEDURE WAS NOT COMPLETED AND ORIGINAL CLOT, WHICH WAS THE REASON FOR ISCHEMIC STROKE, WAS NOT ABLE TO RETRIEVE AND THEREFORE VASCULAR PATENCY COULD NOT BE OBTAINED. THE PATIENT'S CONDITION (HEMIPLEGIA NOTED BEFORE STENT RETRIEVER USAGE) COULD NOT BE IMPROVED COMPARED TO BEFORE THE PROCEDURE. PATIENT WAS STABLE AFTER THE PROCEDURE.

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE FOR STROKE TREATMENT, THE SUBJECT STENT BROKE INSIDE THE PATIENT¿S VASCULATURE. IT IS UNCLEAR IF THE PHYSICIAN REMOVED THE SUBJECT STENT FROM PATIENT VASCULATURE OR IF THE BROKEN PIECE WHICH WAS LEFT IN THE PATIENT. THE PATIENT'S CONDITION COULD NOT BE IMPROVED COMPARED TO BEFORE THE PROCEDURE AS VASCULAR PATENCY COULD NOT BE OBTAINED. PROCEDURE WAS NOT COMPLETED. PATIENT WAS STABLE AFTER THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.