TREVO NXT 4MM X 41MM - US
Received Jan 25, 2021 · Event occurred Dec 29, 2020
Report 3012931345-2021-00020 · MDR key 11227208
Device
Generic name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Manufacturer
Stryker Neurovascular-utah-salt Lake CityModel number
90314Catalog number
90314
Lot number
UNKNOWN
Product problems
- Difficult to Remove
- Difficult to Remove
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE RETRIEVER (SUBJECT DEVICE) HAD DIFFICULTY BEING WITHDRAWN FROM THE PATIENT'S VESSEL DURING THE PROCEDURE. THE SUBJECT RETRIEVER EXPERIENCED RESISTANCE INSIDE THE MICROCATHETER WHILE BEING REMOVED FROM THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Additional Manufacturer Narrative
ALTHOUGH THE DHR COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER REMAINS UNKNOWN, THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, VISUAL AND FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. 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. IT WAS REPORTED THAT THE "SUBJECT RETRIEVER FELT STICKY AND JUMPY WHEN DELIVERING THROUGH A MICROCATHETER AND DURING UNSHEATHE WHICH THEY SAID WAS UNSETTLING. EVERY PASS WAS DIFFICULT IN TRACKING." ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT NO ANOMALIES WERE NOTED TO THE DEVICE AFTER REMOVAL FROM THE PACKAGING OR PRIOR TO PREPARATION, THE DEVICE WAS PREPARED AS PER THE DFU, THE ANATOMY WAS MODERATELY TORTUOUS, CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE LOADING BUT "JUMPING" WAS FELT WHILE THE DEVICE WAS BEING UNSHEATHED IN THE VESSEL, AND FORCE WAS APPLIED TO OVERCOME RESISTANCE TO ADVANCE/WITHDRAW THE RETRIEVER. 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 THIS COMPLAINT.
Additional Manufacturer Narrative
THIS IS 2ND OF 2 REPORTS. DEVICE IS NOT AVAILABLE TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT THE RETRIEVER (SUBJECT DEVICE) HAD DIFFICULTY BEING WITHDRAWN FROM THE PATIENT'S VESSEL DURING THE PROCEDURE. THE SUBJECT RETRIEVER EXPERIENCED RESISTANCE INSIDE THE MICROCATHETER WHILE BEING REMOVED FROM THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.