BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LVIS EVO

    MDR report key: 17012249 · Received May 26, 2023

    Report

    Report Number
    2032493-2023-00749
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    May 15, 2023
    Report Date
    May 22, 2023
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    UDI-DI
    00842429103449
    PMA / PMN Number
    P170013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ITEMS RETURNED FOR INVESTIGATION: PUSHER, MICROCATHETER. ITEMS NOT RETURNED FOR INVESTIGATION: STENT, INTRODUCER. THE PUSHER WAS RETURNED BROKEN AT THE DISTAL TIP. THE MICROCATHETER WAS WAVY AT 50CM FROM THE DISTAL TIP. THE PUSHER DISTAL TIP WAS EXAMINED UNDER HIGH MAGNIFICATION CONFIRMING THAT THE TIP WAS BROKEN.

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE IS REPORTED AVAILABLE BUT HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TREATMENT OF A PATIENT ENROLLED IN THE SELANT STUDY, AN LVIS EVO WAS USED FOR A STENT ASSISTED COILING CASE. IT WAS OBSERVED THAT FOLLOWING SUCCESSFUL DEPLOYMENT OF THE STENT AND SUBSEQUENT WITHDRAWAL OF THE DELIVERY WIRE, THE RADIO-OPAQUE TIP DETACHED FROM THE DELIVERY WIRE. A FOLLOW UP POST PROCEDURE X-RAY AND MR CONFIRMED THERE WERE NO CLINICAL ISSUES. ADDITIONAL INFORMATION INDICATED THE RADIO-OPAQUE TIP REMAINED WITHIN THE STENT. NO INTERVENTION WAS TAKEN TO REMOVE THE TIP. THE PATIENT WAS REPORTED TO BE WELL AND DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL TREATMENT WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728641 LVIS EVO INTRALUMINAL DEVICES QCA MICROVENTION, INC. LEV2522-MVE 0000327229 00842429103449

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other