TREVO NXT 4MM X 41MM - US

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

Description of Event or Problem

IT WAS REPORTED DURING PROCEDURE TO PERFORM ACUTE BLOOD CIRCULATION RECANALIZATION THERAPY FOR M2 OBSTRUCTION, A MICROCATHETER AND SUBJECT RETRIEVER WAS GUIDED USING GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS WHICH CAUSED DIFFICULTY IN ADVANCING THE DEVICES TO THE TARGET SITE. SUBJECT DEVICE WAS ABLE TO CROSS THE OBSTRUCTION SITE AND WAS DEPLOYED. ACCOMPANYING MICROCATHETER WAS REMOVED AND A DIFFERENT CATHETER WAS PLACED ALONG THE SUBJECT RETRIEVER WIRE. PHYSICIAN CONFIRMED BLEEDING FROM THE LESION SITE VIA IMAGING IMMEDIATELY AFTER INDUCTION, INTEGRATION WITH THE STENT RETRIEVER AND REMOVAL FROM THE BODY. A BALLOON CATHETER WAS EXPANDED AND WAITED FOR SEVERAL MINUTES UNDER BLOOD COLLECTION BLOCKAGE, BUT HEMOSTASIS WAS NOT OBTAINED. THE PHYSICIAN THEN GUIDED ANOTHER MICROCATHETER AND VASCULAR EMBOLIZATION WAS PERFORMED USING 3 COILS AND NBCA (N-BUTYL CYANOACRYLATE). AFTER THE PROCEDURE PATIENT WAS NOTED TO HAVE PARALYSIS AND APHASIA. PREOPERATIVE CONDITION OF THE PATIENT IS UNKNOWN AND IT IS UNABLE TO CONFIRM WHETHER THE SYMPTOM HAVE WORSENED. NO FURTHER INFORMATION WAS PROVIDED.

Description of Event or Problem

IT WAS REPORTED DURING PROCEDURE TO PERFORM ACUTE BLOOD CIRCULATION RECANALIZATION THERAPY FOR M2 OBSTRUCTION, A MICROCATHETER AND SUBJECT RETRIEVER WAS GUIDED USING GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS WHICH CAUSED DIFFICULTY IN ADVANCING THE DEVICES TO THE TARGET SITE. SUBJECT DEVICE WAS ABLE TO CROSS THE OBSTRUCTION SITE AND WAS DEPLOYED. ACCOMPANYING MICROCATHETER WAS REMOVED AND A DIFFERENT CATHETER WAS PLACED ALONG THE SUBJECT RETRIEVER WIRE. PHYSICIAN CONFIRMED BLEEDING FROM THE LESION SITE VIA IMAGING IMMEDIATELY AFTER INDUCTION, INTEGRATION WITH THE STENT RETRIEVER AND REMOVAL FROM THE BODY. A BALLOON CATHETER WAS EXPANDED AND WAITED FOR SEVERAL MINUTES UNDER BLOOD COLLECTION BLOCKAGE, BUT HEMOSTASIS WAS NOT OBTAINED. THE PHYSICIAN THEN GUIDED ANOTHER MICROCATHETER AND VASCULAR EMBOLIZATION WAS PERFORMED USING 3 COILS AND NBCA (N-BUTYL CYANOACRYLATE). AFTER THE PROCEDURE PATIENT WAS NOTED TO HAVE PARALYSIS AND APHASIA. PREOPERATIVE CONDITION OF THE PATIENT IS UNKNOWN AND IT IS UNABLE TO CONFIRM WHETHER THE SYMPTOM HAVE WORSENED. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, VISUAL AND FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. BASED ON THE RESULTS OF THE DHR REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. 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 COULD NOT BE CONFIRMED AND IT CANNOT BE CONFIRMED IF THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. AS PER THE ADDITIONAL INFORMATION THE DEVICE WAS PREPARED FOR USE AS PER THE DIRECTIONS FOR USE, NO DAMAGE NOTED TO THE PACKAGING PRIOR TO OPENING THE PACKAGING, DEVICE CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE, AND PATIENT ANATOMY WAS 'VERY TORTUOUS'. AS A PRODUCT RELATED ROOT CAUSE DOES NOT APPLY AND THE ISSUE IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND/OR PATIENT CONDITION NOTED WITH THE DIRECTIONS FOR USE, PRODUCT LABELING AND/OR RISK DOCUMENTATION FILES, AN ASSIGNABLE CAUSE OF PATIENT-ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THE AS REPORTED 'NV - PATIENT HEMORRHAGE, BLOOD LOSS WITH SEQUELAE' AND 'NV - PATIENT NEUROLOGICAL DEFICIT'. 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 'NV - DEVICE DIFFICULTY ENGAGING TARGET VESSEL'. H3 OTHER TEXT : THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.