TREVO NXT 6MM X 37MM - US

Description of Event or Problem

IT WAS REPORTED THAT DURING THE THROMBECTOMY OF INTERNAL CAROTID ARTERY (ICA) OCCLUSION, A SECOND APPROACH WAS PERFORMED DUE TO RESIDUAL THROMBUS. THE STENT DEPLOYMENT PROCEEDED WITHOUT ISSUE, BUT DURING RETRIEVAL, DESPITE PULLING THE ENTIRE SYSTEM, THE SUBJECT STENT DELIVERY WIRE BECAME FRACTURED, LEAVING THE SUBJECT STENT AND PART OF THE WIRE IN THE BODY. SUBSEQUENTLY, ATTEMPTS WERE MADE TO RETRIEVE THE REMAINING DEVICES USING A STENT RETRIEVER AND SNARE DEVICE, BUT THESE PROVED UNSUCCESSFUL. THEREFORE, TREATMENT WAS CONCLUDED WITH THE DEVICES REMAINING INSIDE THE PATIENT'S BODY. THE PATIENT'S ADL WAS ALREADY POOR, AND THE IMPACT OF THIS EVENT IS UNCLEAR.

Additional Manufacturer Narrative

D9 PRODUCT AVAILABLE TO STRYKER: UPDATED. D9 RETURNED TO MANUFACTURER ON: UPDATED. H3 DEVICE EVALUATED BY MFG: UPDATED. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE SUBJECT CORE WIRE WAS CONFIRMED TO HAVE BEEN FRACTURED. THERE WAS EVIDENCE OF NECKING/STRETCHING NOTED TO THE LAMINATION AND THE CORE WIRE. THE DISTAL SECTION OF THE CORE WIRE AND RETRIEVER WERE NOT RETURNED. A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE CORE WIRE HAD BEEN FRACTURED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTION 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 CORE WIRE FRACTURE WAS CONFIRMED BASED ON THE DEVICE ANALYSIS. THE REPORTED RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT WAS UNABLE TO BE REPLICATED DURING ANALYSIS AS THE DISTAL END OF THE RETRIEVER WAS NOT RETURNED. THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED, BASED ON THE DAMAGE NOTED. IT WAS REPORTED THAT THE 1ST PASS HAD NO ISSUE USING THE SUBJECT STENT RETRIEVER. A SECOND APPROACH WAS PERFORMED DUE TO RESIDUAL THROMBUS. THE SUBJECT STENT DEPLOYMENT PROCEEDED WITHOUT ISSUE, BUT DURING RETRIEVAL, DESPITE PULLING THE ENTIRE SYSTEM, THE STENT DELIVERY WIRE BECAME FRACTURED, LEAVING THE STENT AND PART OF THE WIRE REMAINED IN THE BODY. SUBSEQUENTLY, ATTEMPTS WERE MADE TO RETRIEVE THE REMAINING DEVICES USING A STENT RETRIEVER AND SNARE DEVICE, BUT THESE PROVED UNSUCCESSFUL. AS PER THE ADDITIONAL INFORMATION, IT IS UNKNOWN IF ANY FORCE WAS APPLIED AGAINST THE RESISTANCE, TORQUE WAS NOT APPLIED WHEN RETRIEVING THE DEVICE FROM THE BLOOD VESSEL, THE MICROCATHETER DISTAL TIP MARKER WAS MAINTAINED AT THE PROXIMAL END OF THE STENT DURING MANIPULATION OR REMOVAL, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE AND THE PATIENTS ANATOMY WAS OF AVERAGE TORTUOSITY. THE DEVICE WAS RETURNED, AND IT WAS CONFIRMED THAT THE RETRIEVER CORE WIRE HAD BEEN FRACTURED, THERE WAS ALSO DAMAGE NOTED TO THE LAMINATION AT THE FRACTURE LOCATION. IT IS PROBABLE THAT THERE WERE PROCEDURAL AND/OR ANATOMICAL FACTORS PRESENT DURING THE CLINICAL PROCEDURE WHICH CAUSED THE DIFFICULTY TO ADVANCE THE RETRIEVER THROUGH THE CATHETER AND THE SUBSEQUENT RETRIEVER CORE WIRE FRACTURE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED EVENT RETRIEVER CORE WIRE BROKEN DURING USE AND UN-RETRIEVED DEVICE FRAGMENTS AND TO THE ANALYZED DEFECTS RETRIEVER CORE WIRE BROKEN/FRACTURED DURING USE AND RETRIEVER DELIVERY WIRE LAMINATION ISSUE, AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE THROMBECTOMY OF INTERNAL CAROTID ARTERY (ICA) OCCLUSION, A SECOND APPROACH WAS PERFORMED DUE TO RESIDUAL THROMBUS. THE STENT DEPLOYMENT PROCEEDED WITHOUT ISSUE, BUT DURING RETRIEVAL, DESPITE PULLING THE ENTIRE SYSTEM, THE SUBJECT STENT DELIVERY WIRE BECAME FRACTURED, LEAVING THE SUBJECT STENT AND PART OF THE WIRE IN THE BODY. SUBSEQUENTLY, ATTEMPTS WERE MADE TO RETRIEVE THE REMAINING DEVICES USING A STENT RETRIEVER AND SNARE DEVICE, BUT THESE PROVED UNSUCCESSFUL. THEREFORE, TREATMENT WAS CONCLUDED WITH THE DEVICES REMAINING INSIDE THE PATIENT'S BODY. THE PATIENT'S ADL WAS ALREADY POOR, AND THE IMPACT OF THIS EVENT IS UNCLEAR.