BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREVO NXT 6MM X 37MM - US

    MDR report key: 10633058 · Received October 6, 2020

    Report

    Report Number
    3012931345-2020-00152
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    September 10, 2020
    Report Date
    January 14, 2021
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
    Product Code
    POL
    UDI-DI
    07613327299953
    PMA / PMN Number
    K200117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. DURING VISUAL INSPECTION A SUBJECT TREVO NXT RETRIEVER CORE WIRE, STENT PORTION AND A NON -STRYKER GUIDE CATHETER (MICROVENTION - SOFIA) WAS RETURNED. THE TREVO NXT RETRIEVER WAS FRACTURED INTO 2 FRAGMENTS. THE TREVO NXT RETRIEVER STENT SECTION (DISTAL FRAGMENT) WAS RETURNED LODGED WITHIN APPROXIMATELY 13 CM FROM THE SOFIA CATHETER DISTAL TIP. 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 NEAR THE CORE WIRE FRACTURE SITE. THE CORE WIRE AND SHAFT COIL PROXIMAL JUNCTION WAS INTACT. THE CORE WIRE WAS BROKEN DISTAL TO THE ROUND-TO-FLAT CORE WIRE TRANSITION REGION, BUT PROXIMAL TO THE STENT (NEAR MSJ, MID SOLDER JUNCTION). FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE CONDITION THE DEVICE. FROM THE CONDITION OF THE PRODUCT IT APPEARS THAT THE PRODUCT HAD BEEN UNDER EXCESSIVE MANIPULATION. 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, THE CORE WIRE PEBAX LAMINATION WAS ALSO DAMAGED. 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 WAS ASSIGNED TO THE REPORTED AND ANALYZED ISSUE RETRIEVER FRACTURED/BROKEN DURING USE AND THE ANALYZED ISSUE RETRIEVER DELIVERY WIRE LAMINATION DAMAGE/PEELING, 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 THE SUBJECT RETRIEVER WAS USED DURING THE THROMBECTOMY PROCEDURE FOR THE ICA OCCLUSION. THE INTRODUCER SHEATH DISTAL END OF THE FIRST RETRIEVER LOOKED TWISTED PRIOR TO THE SECOND PASS; THEREFORE, THE PHYSICIAN NEEDED TO OPEN THE SUBJECT SECOND RETRIEVER. THE SECOND RETRIEVER WAS FRACTURED WHEN RETRACTED FROM THE VASCULATURE. THE DETACHED RETRIEVER WAS REMOVED FROM THE PATIENT ANATOMY. THE PROCEDURE WAS COMPETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT RETRIEVER WAS USED DURING THE THROMBECTOMY PROCEDURE FOR THE ICA OCCLUSION. THE INTRODUCER SHEATH DISTAL END OF THE FIRST RETRIEVER LOOKED TWISTED PRIOR TO THE SECOND PASS; THEREFORE, THE PHYSICIAN NEEDED TO OPEN THE SUBJECT SECOND RETRIEVER. THE SECOND RETRIEVER WAS FRACTURED WHEN RETRACTED FROM THE VASCULATURE. THE DETACHED RETRIEVER WAS REMOVED FROM THE PATIENT ANATOMY. THE PROCEDURE WAS COMPETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101184 TREVO NXT 6MM X 37MM - US NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT POL STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY 90315 0000046689 07613327299953

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR MARKSMAN MICROCATHETER (MEDTRONIC)| SOFIA ASPIRATION CATHETER (MICROVENTION)| TREVO NXT RETRIEVER (STRYKER)| MARKSMAN MICROCATHETER (MEDTRONIC)| SOFIA ASPIRATION CATHETER (MICROVENTION)| TREVO NXT RETRIEVER (STRYKER)