BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXNAV DELIVERY SYSTEM

    MDR report key: 19297516 · Received May 13, 2024

    Report

    Report Number
    2135147-2024-02139
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 23, 2024
    Report Date
    June 6, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031389
    PMA / PMN Number
    P190023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF DIFFICULT TO REMOVE (ENTANGLEMENT WITH THE VALVE) 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. THE COMPLAINT DATABASE WAS REVIEWED, AND THERE WERE NO RELATED INCIDENTS FOUND FOR THE LOT. INFORMATION FROM THE FIELD INDICATED THAT AFTER DEPLOYMENT, THE VALVE MIGRATED TOWARDS THE ASCENDING AORTA. THERE WAS REPORTEDLY INTERACTION OF THE DELIVERY SYSTEM WITH THE VALVE, BUT DID NOT CAUSE THE MIGRATION. THERE WAS NO TENSION IN THE DELIVERY SYSTEM. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING. THE ADDITIONAL NVTR-27 DEVICE REFERENCED IN B5 IS FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.

    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

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 23 APRIL 2024, A 27MM NAVITOR VALVE (SERIAL: (B)(6)) WAS CHOSEN FOR IMPLANTATION UTILIZING A FLEXNAV DELIVERY SYSTEM (LOT: 9138320). THE PATIENT PRESENTED WITH SUFFICIENT CALCIUM. AT 80% DEPLOYMENT THE VALVE WAS AT A DEPTH OF 2MM.THE VALVE WAS DEPLOYED AT A DEPTH OF 2MM. AFTER DEPLOYMENT, THE VALVE MIGRATED TOWARDS THE ASCENDING AORTA. THERE WAS REPORTEDLY INTERACTION OF THE DELIVERY SYSTEM WITH THE VALVE, BUT DID NOT CAUSE THE MIGRATION. NO POST DILATATION WAS PERFORMED. THERE WAS NO TENSION IN THE DELIVERY SYSTEM. A REPLACEMENT 27MM NAVITOR (SERIAL: (B)(6)) WAS IMPLANTED VALVE IN VALVE AT A DEPTH OF 3MM UTILIZING A REPLACEMENT FLEXNAV (LOT: 9943385). THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842177 FLEXNAV DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 9138320 05415067031389

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Male LARGE FLEXNAV DELIVERY SYSTEM