BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXNAV DELIVERY SYSTEM

    MDR report key: 19298040 · Received May 13, 2024

    Report

    Report Number
    2135147-2024-02142
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 23, 2024
    Report Date
    June 24, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031372
    PMA / PMN Number
    P190023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF DIFFICULT TO INSERT AND MATERIAL DEFORMATION WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. REPORTEDLY, THE PATIENT HAVE TORTUOUS AND CALCIFIED ANATOMY. WHILE ADVANCING THE FLEXNAV THROUGH THE ANATOMY, IT WAS UNABLE TO PASS THROUGH THE RIGHT EXTERNAL ILIAC ARTERY. CONSIDERABLE LOAD WAS APPLIED TO THE FLEXNAV, RESULTING IN THE VALVE CAPSULE BECOMING BENT. BASED ON THE INFORMATION RECEIVED, A CAUSE FOR THE REPORTED DIFFICULT TO INSERT AND MATERIAL DEFORMATION APPEAR TO BE RELATED TO PATIENT ANATOMY AND PROCEDURE CONDITION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM NAVITOR VALVE (SERIAL: (B)(6)) WAS CHOSEN FOR IMPLANTATION UTILIZING A SMALL FLEXNAV DELIVERY SYSTEM (LOT: 9212797). THE HAD TORTUOUS AND CALCIFIED ANATOMY. WHILE ADVANCING THE FLEXNAV THROUGH THE ANATOMY, IT WAS UNABLE TO PASS THROUGH THE RIGHT EXTERNAL ILIAC ARTERY. CONSIDERABLE LOAD WAS APPLIED TO THE FLEXNAV, RESULTING IN THE VALVE CAPSULE BECOMING BENT. A REPLACEMENT FLEXNAV (LOT: 9212797) AND 25MM NAVITOR (SERIAL: (B)(6)) WAS THEN IMPLANTED SUCCESSFULLY, USING A INTRODUCER SHEATH. THE PATIENT WAS REPORTED TO BE STABLE. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843208 FLEXNAV DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 9212797 05415067031372

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female