TREVO NXT 4MM X 41MM - US

Description of Event or Problem

IT WAS REPORTED THAT A MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED FOR ACUTE CEREBRAL ISCHEMIA, IN LEFT MIDDLE CRANIAL ARTERY DISTAL OCCLUSION IN A PATIENT. DURING THE PROCEDURE, RECANALIZATION COULD NOT BE OBTAINED IN THE FIRST PASS USING THE SUBJECT RETRIEVER STENT, THUS A SECOND PASS WAS MADE WITH THE SUBJECT RETRIEVER STENT. THE SUBJECT STENT GOT PREMATURELY DEPLOYED BETWEEN M2 AND M1 DURING THE SECOND PASS. THE OPERATOR ATTEMPTED TO RETRIEVE THE SUBJECT RETRIEVER STENT BY ASPIRATING IT THROUGH THE BACK LOCK SYRINGE, WITHOUT REMOVING THE MICROCATHETER. THE OPERATOR WAS ABLE TO RETRIEVE ONLY THE SUBJECT RETRIEVER STENT DELIVERY WIRE OUT, LEAVING THE SUBJECT RETRIEVER STENT INSIDE THE PATIENT'S VASCULAR ANATOMY AS THE SUBJECT STENT WAS FRACTURED AT THE JUNCTION BETWEEN THE STENT AND THE DELIVERY WIRE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT (CONFIRMED ON (B)(6), 2021 BY THE DOCTOR). NO FURTHER INFORMATION IS AVAILABLE ON THE CURRENT CONDITION OF THE PATIENT.

Additional Manufacturer Narrative

H3 SUMMARY ATTACHED - UPDATED. H3 DEVICE EVALUATED BY MFG ¿UPDATED. H4 MANUFACTURING DATE ¿ ADDED. D4 EXPIRATION DATE - ADDED. 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. VISUAL/MICROSCOPIC INSPECTION: THE RETRIEVER SHAPED SECTION WAS DETACHED AND NOT RETURNED. THE INSERTION TOOL WAS NOT RETURNED. THE CORE WIRE WAS KINKED. THE RETRIEVER CORE WIRE WAS BROKEN AND THE PEBAX WAS DAMAGED. FUNCTIONAL TEST: UNABLE TO CARRY OUT DUE TO CONDITION OF RETURNED DEVICE. 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 DEVICE WAS RETURNED AND IT WAS CONFIRMED THAT THE RETRIEVER CORE WIRE WAS FRACTURED. IT IS PROBABLE THAT THERE WERE PROCEDURAL AND/OR ANATOMICAL FACTORS PRESENT DURING THE CLINICAL PROCEDURE WHICH CAUSED THE RETRIEVER CORE WIRE TO FRACTURE DURING THE ATTEMPT TO REMOVE FROM THE PATIENT. NC# (B)(4) WAS OPENED FOR INCREASE IN RETRIEVER CORE WIRE FRACTURE COMPLAINTS. THIS EVENT IS BEING ADDRESSED VIA CAPA# 2878186. AN ASSIGNABLE CAUSE OF 'PROCEDURAL FACTORS' WILL BE ASSIGNED TO THE AS REPORTED 'UN-RETRIEVED DEVICE FRAGMENTS' AND THE AS REPORTED/AS ANALYZED 'RETRIEVER CORE WIRE BROKEN DURING USE' AND THE ANALYZED 'RETRIEVER DELIVERY WIRE LAMINATION DAMAGE/PEELING', AND 'RETRIEVER CORE WIRE KINKED' 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 A MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED FOR ACUTE CEREBRAL ISCHEMIA, IN LEFT MIDDLE CRANIAL ARTERY DISTAL OCCLUSION IN A PATIENT. DURING THE PROCEDURE, RECANALIZATION COULD NOT BE OBTAINED IN THE FIRST PASS USING THE SUBJECT RETRIEVER STENT, THUS A SECOND PASS WAS MADE WITH THE SUBJECT RETRIEVER STENT. THE SUBJECT STENT GOT PREMATURELY DEPLOYED BETWEEN M2 AND M1 DURING THE SECOND PASS. THE OPERATOR ATTEMPTED TO RETRIEVE THE SUBJECT RETRIEVER STENT BY ASPIRATING IT THROUGH THE BACK LOCK SYRINGE, WITHOUT REMOVING THE MICROCATHETER. THE OPERATOR WAS ABLE TO RETRIEVE ONLY THE SUBJECT RETRIEVER STENT DELIVERY WIRE OUT, LEAVING THE SUBJECT RETRIEVER STENT INSIDE THE PATIENT'S VASCULAR ANATOMY AS THE SUBJECT STENT WAS FRACTURED AT THE JUNCTION BETWEEN THE STENT AND THE DELIVERY WIRE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT (CONFIRMED ON (B)(6) 2021 BY THE DOCTOR). NO FURTHER INFORMATION IS AVAILABLE ON THE CURRENT CONDITION OF THE PATIENT.