BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREVO NXT 6MM X 37MM - US

    MDR report key: 16363358 · Received February 13, 2023

    Report

    Report Number
    3012931345-2023-00017
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    February 6, 2023
    Report Date
    May 10, 2023
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
    Product Code
    POL
    UDI-DI
    07613327299953
    PMA / PMN Number
    K200117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H4 MANUFACTURING DATE ¿ ADDED. H3 DEVICE EVALUATED BY MFG ¿UPDATED. H3 SUMMARY ATTACHED ¿ UPDATED. D4 EXPIRATION DATE - ADDED. D9 PRODUCT AVAILABLE TO STRYKER ¿ UPDATED. D9 RETURNED TO MANUFACTURER ON ¿UPDATED. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE DEVICE WAS RETURNED, AND THE LOT NUMBER WAS CONFIRMED WITH THE PACKAGING RETURNED WITH THE DEVICE. DURING VISUAL INSPECTION, THE RETRIEVER SHAPED SECTION WAS BROKEN/DETACHED FROM THE CORE WIRE AT THE CORE WIRE MSJ TO PEBAX TRANSITION LENGTH JUNCTION. A FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE DAMAGE NOTED TO THE 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 REPORTED COMPLAINT WAS CONFIRMED BASED ON ANALYSIS. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO DEPLOY THE STENT FROM M2 TO M1, THE RETRIEVER WAS BROKEN OFF FROM THE DELIVERY WIRE AT THE FIRST PASS. THE STENT REMAINING IN THE BODY WAS RETRIEVED USING A SNARE DEVICE. ADDITIONAL INFORMATION STATES THAT RESISTANCE WAS EXPERIENCED WITHIN THE MICROCATHETER, THE WAS DEVICE PREPARED FOR USE AS PER THE DIRECTIONS FOR USE, THE DEVICE WAS 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 THE PATIENTS ANATOMY WAS NORMAL. THE DEVICE WAS RETURNED AND THE RETRIEVER CORE WIRE WAS CONFIRMED O BE BROKEN/ FRACTURED AT THE MSJ TO PEBAX TRANSITION LENGTH JUNCTION. SEM IMAGING WAS PERFORMED ON THE FRACTURE POINT WHICH SHOWED BENDING AT THE FRACTURE POINT WITH EVIDENCE OF DUCTILE OVERLOAD FAILURE UNDER BENDING LOAD. IT IS PROBABLE THAT SOME STRESSES MAY HAVE BEEN EXERTED ON THE RETRIEVER CORE WIRE CAUSING THE REPORTED BREAK/FRACTURE, DUE TO THE RESISTANCE THAT WAS EXPERIENCED WITHIN THE MICROCATHETER. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED EVENTS OF RETRIEVER FRACTURE/BROKEN DURING USE AND RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT AND TO THE ANALYSED EVENT OF RETRIEVER CORE WIRE BROKEN DURING USE, AS THESE ISSUES ARE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A THROMBUS REMOVAL PROCEDURE WHEN ATTEMPTING TO DEPLOY THE RETRIEVER (SUBJECT DEVICE) IT DETACHED FROM THE DELIVERY WIRE. A SNARE WAS USED TO REMOVE THE SUBJECT RETRIEVER FROM THE PATIENT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A THROMBUS REMOVAL PROCEDURE WHEN ATTEMPTING TO DEPLOY THE RETRIEVER (SUBJECT DEVICE) IT DETACHED FROM THE DELIVERY WIRE. A SNARE WAS USED TO REMOVE THE SUBJECT RETRIEVER FROM THE PATIENT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388081 TREVO NXT 6MM X 37MM - US NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT POL STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY 90315 0000105274 07613327299953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention PHENOM21 MICROCATHETER (MEDRONIC)| SNARE (UNKNOWN)