TREVO NXT 4MM X 41MM - US

Additional Manufacturer Narrative

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 WAS RETURNED DETACHED. THE RETRIEVER WAS FRACTURED AT THE CORE WIRE. THE DETACHED AREA OF THE CORE WIRE WAS PUSHED BACK WITHIN THE RETRIEVER SHAPED SECTION. THE RETRIEVER SHAPED SECTION WAS DAMAGED. THE INSERTION TOOL WAS NOT RETURNED. THE POLYMER JACKET IS SHOWN TO HAVE SLIGHT DEFORMATION NOTED, THERE IS A BEND ON CORE WIRE JUST PROXIMAL TO FRACTURE SITE AS. THE CORE WIRE WAS BENT. FUNCTIONAL TEST: NOT REQUIRED AS THE CORE WIRE WAS FRACTURED. 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 THE SUBJECT DEVICE FRACTURED WHEN IT BECAME STUCK IN NON-STRYKER CATHETER (COULD NOT BE PULLED OUT). IT IS PROBABLE THAT THERE WERE PROCEDURAL AND/OR ANATOMICAL FACTORS PRESENT DURING THE CLINICAL PROCEDURE WHICH CAUSED THE EVENT. 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/AS ANALYZED CODE 'RETRIEVER CORE WIRE BROKEN DURING USE' AND THE ANALYZED 'RETRIEVER SHAPED SECTION DAMAGE', 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 MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED IN A PATIENT WITH ACUTE CEREBRAL INFARCTION IN MCA (MIDDLE COMMUNICATING ARTERY) WITH VERY TORTUOUS VASCULAR ANATOMY. DURING THE PROCEDURE, THE LEFT M1 DISTAL THROMBUS WAS RETRIEVED WITH THE SUBJECT RETRIEVER STENT AND MICROCATHETER. WHEN THE THIRD PASS WAS COMPLETED AND THE SUBJECT STENT RETRIEVER WAS STUCK INSIDE THE MICROCATHETER. PHYSICIAN TRIED TO MOVE THE DELIVERY WIRE BACK AND FORTH BUT ONLY THE SUBJECT RETRIEVER STENT DELIVERY WIRE CAME OUT. WHEN THE LOCATION OF THE STENT WAS CHECKED UNDER FLUOROSCOPY, IT WAS CONFIRMED THAT THE SUBJECT RETRIEVER STENT WAS STUCK AT THE TIP, INSIDE THE MICROCATHETER. THE SUBJECT RETRIEVER STENT ALONG WITH THE MICROCATHETER WERE RETRIEVED OUT OF THE PATIENT'S VASCULAR ANATOMY. PTA (PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY) WAS PERFORMED USING BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

Description of Event or Problem

IT WAS REPORTED THAT MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED IN A PATIENT WITH ACUTE CEREBRAL INFARCTION IN MCA (MIDDLE COMMUNICATING ARTERY) WITH VERY TORTUOUS VASCULAR ANATOMY . DURING THE PROCEDURE, THE LEFT M1 DISTAL THROMBUS WAS RETRIEVED WITH THE SUBJECT RETRIEVER STENT AND MICROCATHETER. WHEN THE THIRD PASS WAS COMPLETED AND THE SUBJECT STENT RETRIEVER WAS STUCK INSIDE THE MICROCATHETER. PHYSICIAN TRIED TO MOVE THE DELIVERY WIRE BACK AND FORTH BUT ONLY THE SUBJECT RETRIEVER STENT DELIVERY WIRE CAME OUT. WHEN THE LOCATION OF THE STENT WAS CHECKED UNDER FLUOROSCOPY, IT WAS CONFIRMED THAT THE SUBJECT RETRIEVER STENT WAS STUCK AT THE TIP, INSIDE THE MICROCATHETER. THE SUBJECT RETRIEVER STENT ALONG WITH THE MICROCATHETER WERE RETRIEVED OUT OF THE PATIENT'S VASCULAR ANATOMY. PTA (PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY) WAS PERFORMED USING BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.