BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 19297497 · Received May 13, 2024

    Report

    Report Number
    2135147-2024-02138
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    April 23, 2024
    Report Date
    July 26, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031594
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. H6 - MEDICAL DEVICE PROBLEM CODE: 2017 - IMPROPER OR INCORRECT PROCEDURE OR METHOD. THE FLEXNAV DELIVERY SYSTEM DESCRIBED IN B5 WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 0

    H6 MEDICAL DEVICE PROBLEM CODES 2017 WAS REMOVED AND REPLACED WITH 1494. AN EVENT OF OFF-LABEL USE AND MIGRATION OR EXPULSION OF DEVICE 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. INFORMATION FROM THE FIELD INDICATED THAT 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. THERE WAS NO TENSION IN THE DELIVERY SYSTEM. A REPLACEMENT 27MM NAVITOR WAS IMPLANTED VALVE IN VALVE AT A DEPTH OF 3MM. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE OF THE REPORTED DEVICE MIGRATION COULD NOT BE DETERMINED. THE REPORTED OFF-LABEL USE APPEARS TO BE RELATED TO USER AS THE USER IMPLANTED THE NAVITOR VALVE INTO A PREVIOUSLY IMPLANTED (VALVE-IN-VALVE IMPLANTED). 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 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
    846212 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 8948617 05415067031594

    Patients

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