BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT INTRODUCER, UNKNOWN

    MDR report key: 18614924 · Received January 31, 2024

    Report

    Report Number
    3008452825-2024-00064
    Event Type
    Injury
    Date Received
    January 31, 2024
    Report Date
    March 4, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN JACC: CARDIOVASCULAR INTERVENTIONS. 2023;16(23):2854-2865. ELSEVIER INC. (DEC 11, 2023) "1-YEAR OUTCOMES FOLLOWING TRANSFEMORAL TRANSSEPTAL TRANSCATHETER MITRAL VALVE REPLACEMENT: THE HIGHLIFE TSMVR FEASIBILITY STUDY"; SCHNEIDER L, WORTHLEY S, NICKENIG G, ET AL. THIS PROSPECTIVE, MULTICENTER, NONRANDOMIZED FEASIBILITY STUDY EVALUATED THE SAFETY AND PERFORMANCE OF THE HIGHLIFE TSMVR SYSTEM IN PATIENTS WITH MODERATE TO SEVERE OR SEVERE SYMPTOMATIC MR DURING 1-YEAR FOLLOW-UP. ECHOCARDIOGRAPHIC DATA WERE ASSESSED AT AN INDEPENDENT CORE LABORATORY. A TOTAL OF 30 PATIENTS WITH SEVERE MR WERE TREATED AT 13 SITES. IN 27 OF THE 30 PATIENTS, THE HIGHLIFE TSMVR SYSTEM WAS IMPLANTED SUCCESSFULLY. DEVICE SUCCESS AT 30 DAYS WAS 83%. AFTER 1 YEAR, 5 PATIENTS HAD DIED. NONE OF THE PATIENTS WHO UNDERWENT IMPLANTATION REQUIRED MITRAL VALVE REINTERVENTION. ALL PATIENTS WHO UNDERWENT IMPLANTATION HAD NO OR TRACE OR MILD MR, THE MEAN GRADIENT OF THE HIGHLIFE VALVE WAS 5.1 MM HG, AND THERE WERE NO SIGNS OF LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION. ONE PATIENT EXPERIENCED BLEEDING FROM THE VENOUS ACCESS SITE REQUIRING SURGICAL FEMORAL VEIN REPAIR AND ONE FROM THE ARTERIAL ACCESS SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415410 AGILIS NXT INTRODUCER, UNKNOWN INTRODUCER, CATHETER DYB ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L