BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREVO NXT 4MM X 41MM - US

    MDR report key: 10947273 · Received December 4, 2020

    Report

    Report Number
    3012931345-2020-00211
    Event Type
    Injury
    Date Received
    December 4, 2020
    Date of Event
    November 8, 2020
    Report Date
    March 10, 2021
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
    Product Code
    POL
    UDI-DI
    07613327299946
    PMA / PMN Number
    K200117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H4 MANUFACTURING DATE ¿ ADDED H3 DEVICE EVALUATED BY MFG ¿UPDATED H3 SUMMARY ATTACHED - UPDATED D4 EXPIRATION DATE - ADDED BASED ON THE RESULTS OF THE DEVICE HISTORY RECORD (DHR) REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. THE REPORTED LOT NUMBER WAS CONFIRMED FROM THE RETURNED PACKAGING. THE DEVICE WAS RETURNED WITHOUT THE INSERTION TOOL AND CATHETER THAT WAS USED. THE REPORTED LOT NUMBER WAS CONFIRMED FROM THE RETURNED PACKAGING. ON VISUAL INSPECTION, AFTER DECONTAMINATION THE TREVO NXT RETRIEVER DEVICE WAS EXAMINED AND IT WAS OBSERVED THAT THE TREVO NXT RETRIEVER WAS FRACTURED. THE TREVO NXT RETRIEVER STENT SECTION (DISTAL FRAGMENT) WAS LEFT IN PATIENT. THE REST OF THE DEVICE WAS FOUND OUTSIDE OF THE SOFIA WITHIN THE PACKAGING. THE TREVO NXT RETRIEVER CORE WIRE AND PROXIMAL SHAFT COIL WERE EXAMINED. DAMAGE WAS SEEN ON THE PEBAX LAMINATE/JACKET NEAR THE CORE WIRE FRACTURE SITE. THE CORE WIRE WAS BROKEN. THE FRACTURE OCCURRED DISTAL TO THE ROUND-TO-FLAT CORE WIRE TRANSITION REGION, BUT PROXIMAL TO THE STENT (NEAR MSJ, MID SOLDER JUNCTION). PERFORMANCE TESTING WAS NOT PERFORMED DUE TO THE CONDITION THE DEVICE WAS RECEIVED. 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 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. AN ASSIGNABLE CAUSE OF 'PROCEDURAL FACTORS' WILL BE ASSIGNED TO THE AS REPORTED AND AS ANALYZED CODE '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 · 0

    IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE IN A TRUNCATED OCCLUDED RIGHT MIDDLE CEREBRAL ARTERY, THE SUBJECT RETRIEVER FRACTURED AT THE JUNCTION AND WAS UNABLE TO BE REMOVED FROM THE PATIENT ANATOMY. PATIENT ANATOMY WAS NOT TORTUOUS AND RESISTANCE DURING THE PROCEDURE WAS NOT REPORTED. THE PHYSICIAN TRIED TO REMOVE THE FRAGMENT FOR TWO HOURS WITH A SNARE AND ADDITIONAL STENT RETRIEVER WHICH WAS DEPLOYED DISTALLY TO TRY AND LATCH BUT WAS NOT SUCCESSFUL. PATIENT WAS REPORTED TO BE ALIVE AND ADDITIONAL IMAGING WAS REQUIRED TO DETERMINE IF ADDITIONAL MEDICATION WOULD BE GIVEN DUE TO THIS EVENT. THE CLOT WAS PARTIALLY REMOVED AND PERFUSION SCORE OF THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 2B WAS ACHIEVED. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE IN A TRUNCATED OCCLUDED RIGHT MIDDLE CEREBRAL ARTERY, THE SUBJECT RETRIEVER FRACTURED AT THE JUNCTION AND WAS UNABLE TO BE REMOVED FROM THE PATIENT ANATOMY. PATIENT ANATOMY WAS NOT TORTUOUS AND RESISTANCE DURING THE PROCEDURE WAS NOT REPORTED. THE PHYSICIAN TRIED TO REMOVE THE FRAGMENT FOR TWO HOURS WITH A SNARE AND ADDITIONAL STENT RETRIEVER WHICH WAS DEPLOYED DISTALLY TO TRY AND LATCH BUT WAS NOT SUCCESSFUL. PATIENT WAS REPORTED TO BE ALIVE AND ADDITIONAL IMAGING WAS REQUIRED TO DETERMINE IF ADDITIONAL MEDICATION WOULD BE GIVEN DUE TO THIS EVENT. THE CLOT WAS PARTIALLY REMOVED AND PERFUSION SCORE OF THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 2B WAS ACHIEVED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411764 TREVO NXT 4MM X 41MM - US NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT POL STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY 90314 0000044937 07613327299946

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| R HEADWAY 21 CATHETER (UNKNOWN)| HEADWAY 21 CATHETER (UNKNOWN)