TREVO NXT 3MM X 32MM - US

Additional Manufacturer Narrative

DUE TO THE AUTOMATED MES (MANUFACTURING EXECUTION SYSTEM) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT 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 EVENT WAS UNABLE TO BE CONFIRMED AND IT CANNOT BE CONFIRMED THAT THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE SUBJECT RETRIEVER, THE VESSEL STRETCH OCCURRED, AND THE STENT RETRIEVER WAS IMPOSSIBLE TO BE RETRIEVED. A MICROCATHETER WAS PLACED OVER THE VESSEL AND THE SUBJECT STENT RETRIEVER WAS RE-SHEATHED. THEN DEPLOYED THE STENT RETRIEVER AGAIN AND ATTEMPTED TO RETRIEVE THE THROMBUS; HOWEVER, THE BLOOD VESSEL GOT STRETCHED IN THE SAME WAY AND THE STENT RETRIEVER WAS TRAPPED, MAKING IT IMPOSSIBLE TO RETRIEVE THE THROMBUS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE, THE PATIENTS ANATOMY WAS SEVERELY TORTUOSITY. FRICTION OR RESISTANCE WAS FELT IN THE VESSEL. THE BLOOD VESSELS EXPAND AND CONTRACT AFTER THE STENT WAS DEPLOYED, AND THE STENT RETRIEVER WAS TRAPPED IN THE VESSEL. IT IS PROBABLE THAT THERE WERE ANATOMICAL AND/OR PROCEDURAL FACTORS (SEVERELY TORTUOSITY ANATOMY) PRESENT DURING THE CLINICAL PROCEDURE WHICH CAUSED THE FRICTION REPORTED DURING THE ATTEMPT TO REMOVE THE RETRIEVER AND THE SUBSEQUENT VESSEL TRAUMA. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED 'DIFFICULT/UNABLE TO RE-SHEATH THE RETRIEVER' AND 'PATIENT COMPLICATIONS', 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 THROMBUS RETRIEVAL AT M2 USING THE SUBJECT STENT RETRIEVER, THE VESSEL EXPERIENCED STRETCHING AFTER THE STENT RETRIEVER WAS DEPLOYED, MAKING IT IMPOSSIBLE TO RETRIEVE (THE BLOOD VESSELS EXPAND AND CONTRACT AFTER THE STENT WAS DEPLOYED, AND THE STENT RETRIEVER WAS TRAPPED IN THE VESSEL). A MICROCATHETER WAS PLACED, AND THE STENT RETRIEVER WAS RE-SHEATHED AND REDEPLOYED. HOWEVER, THE SAME STRETCHING ISSUE OCCURRED, TRAPPING THE STENT RETRIEVER AND PREVENTING THROMBUS RETRIEVAL. THE STENT RETRIEVER WAS THEN REPLACED, WHICH SUCCESSFULLY RETRIEVED THE THROMBUS WITHOUT COMPLICATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN WHETHER THE VESSEL STRETCHING WAS CAUSED BY THE SUBJECT STENT RETRIEVER. NO ADDITIONAL INFORMATION IS AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THROMBUS RETRIEVAL AT M2 USING THE SUBJECT STENT RETRIEVER, THE VESSEL EXPERIENCED STRETCHING AFTER THE STENT RETRIEVER WAS DEPLOYED, MAKING IT IMPOSSIBLE TO RETRIEVE (THE BLOOD VESSELS EXPAND AND CONTRACT AFTER THE STENT WAS DEPLOYED, AND THE STENT RETRIEVER WAS TRAPPED IN THE VESSEL). A MICROCATHETER WAS PLACED, AND THE STENT RETRIEVER WAS RE-SHEATHED AND REDEPLOYED. HOWEVER, THE SAME STRETCHING ISSUE OCCURRED, TRAPPING THE STENT RETRIEVER AND PREVENTING THROMBUS RETRIEVAL. THE STENT RETRIEVER WAS THEN REPLACED, WHICH SUCCESSFULLY RETRIEVED THE THROMBUS WITHOUT COMPLICATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN WHETHER THE VESSEL STRETCHING WAS CAUSED BY THE SUBJECT STENT RETRIEVER. NO ADDITIONAL INFORMATION IS AVAILABLE.