BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXNAV DELIVERY SYSTEM

    MDR report key: 20695255 · Received November 15, 2024

    Report

    Report Number
    2135147-2024-05782
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 23, 2024
    Report Date
    December 30, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031389
    PMA / PMN Number
    P190023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF DIFFICULT TO ADVANCE THROUGH PATIENT ANATOMY AND BENT ON THE DELIVERY SYSTEM WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REPORTEDLY, DURING THE PROCEDURE, FLEXNAV WAS UNABLE TO ADVANCE THROUGH THE RIGHT FEMORAL ARTERY, CAUSING THE FLEXNAV VALVE CAPSULE TO BECOME DAMAGED. THE SYSTEM WAS REMOVED AND REPLACED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    ¿ INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 29MM NAVITOR VISION TRANSCATHETER AORTIC VALVE (SERIAL: (B)(6) WAS CHOSEN FOR IMPLANTATION UTILIZING A LARGE FLEXNAV DELIVERY SYSTEM (LOT: 10191770). THE FLEXNAV WAS UNABLE TO ADVANCE THROUGH THE RIGHT FEMORAL ARTERY, CAUSING THE FLEXNAV VALVE CAPSULE TO BECOME DAMAGED. THE VESSEL SIZE WAS GREATER THAN 5.5MM AND THERE WAS NO CALCIFICATION. A REPLACEMENT 29MM NAVITOR VISION (SERIAL: (B)(6) AND LARGE FLEXNAV DELIVERY SYSTEM (LOT: 9061754) WERE USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324192 FLEXNAV DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 10191770 05415067031389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown