TREVO NXT 6MM X 37MM - US

Additional Manufacturer Narrative

THE SUBJECT DEVICE IS UNAVAILABLE TO MANUFACTURER.

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE, THE RETRIEVER (SUBJECT DEVICE) HAD DIFFICULTY BEING ADVANCED THROUGH THE MICROCATHETER. UPON THE REMOVAL OF THE CLOT, THE RETRIEVER (SUBJECT DEVICE) WAS STUCK IN THE MICROCATHETER. LUCKILY, THE PHYSICIAN WAS ABLE TO REMOVE THE RETRIEVER (SUBJECT DEVICE) TOGETHER WITH THE MICROCATHETER AND CLOT COMPLETELY FROM PATIENT. THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 3 REVASCULARIZATION WITH FIRST PASS. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

Additional Manufacturer Narrative

SECTION B1 PRODUCT PROBLEM: CORRECTED: NO PRODUCT PROBLEM. SECTION H1: TYPE OF REPORTABLE EVENT: CORRECTED: NO PRODUCT PROBLEM. DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT RETRIEVER DEVICE WAS RETURNED AND THE SUBJECT RETRIEVER DEVICE WAS INTACT. THERE WAS BLOOD ON THE RETRIEVER. THE DELIVERY WIRE WAS INTACT. THE CONCURRENT TRAK 21 CATHETER WAS FOUND TO BE FLATTENED AT THE DISTAL AREA. THE SYSTEM WAS FLUSHED AND THE RETRIEVER WAS INSERTED, ADVANCED AND RETRACTED THROUGH THE CONCURRENT TRAK 21 CATHETER WITHOUT ANY ISSUE. THE DISTAL SHAFT OF THE TRAK 21 CATHETER WAS FOUND DAMAGED BUT THE DIFFICULTY IN THE PROCEDURE WAS FELT AT THE PROXIMAL END OF THE CATHETER. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS RECEIVED. THEREFORE, THE AS REPORTED WILL NOT BE CONFIRMED. 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. IN THE CASE OF THIS COMPLAINT IT IS MOST LIKELY THAT THE ISSUE OCCURRED DUE TO PROCEDURAL OR ANATOMICAL FACTORS DURING THE PROCEDURE. THIS HOWEVER CANNOT BE CONCLUSIVELY DETERMINED. THE DEVICE WAS RETURNED, AND A REVIEW OF ANALYSIS AND ALL AVAILABLE INFORMATION FAILS TO INDICATE AN ASSIGNABLE CAUSE OR PROBABLE ASSIGNABLE CAUSE FOR THE REPORTED EVENT, AN ASSIGNABLE CAUSE OF NOT CONFIRMED WILL BE ASSIGNED TO THIS COMPLAINT. NO ISSUE WAS NOTED WITH THE RETURNED RETRIEVER. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE, THE RETRIEVER (SUBJECT DEVICE) HAD DIFFICULTY BEING ADVANCED THROUGH THE MICROCATHETER. UPON THE REMOVAL OF THE CLOT, THE RETRIEVER (SUBJECT DEVICE) WAS STUCK IN THE MICROCATHETER. LUCKILY, THE PHYSICIAN WAS ABLE TO REMOVE THE RETRIEVER (SUBJECT DEVICE) TOGETHER WITH THE MICROCATHETER AND CLOT COMPLETELY FROM PATIENT. THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 3 REVASCULARIZATION WITH FIRST PASS. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES REPORTED TO THE PATIENT