BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 18596901 · Received January 29, 2024

    Report

    Report Number
    2135147-2024-00398
    Event Type
    Malfunction
    Date Received
    January 29, 2024
    Date of Event
    November 2, 2023
    Report Date
    March 20, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031587
    PMA / PMN Number
    P190023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Additional Manufacturer Narrative · 0

    AN EVENT OF DIFFICULTIES IN ADVANCING THE VALVE IN THE DELIVERY SYSTEM WAS REPORTED. INFORMATION FROM THE FIELD INDICATED THAT THE MISLOADING OF ONE OF THE TABS WAS OBSERVED ON CINE REACHING ANNULUS. THE CAUSE OF THE MISLOADING OF ONE OF THE TABS ON CINE WAS THOUGHT TO BE AS A RESULT OF DIFFICULT INSERTION FROM FEMORAL ACCESS POINT. 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 THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6)2023, A SMALL FLEXNAV DELIVERY SYSTEM (9122203) WAS SELECTED TO IMPLANT A 25MM NAVITOR VALVE (20003067). THE NATIVE ANNULUS AND LEAFLETS WERE NOTED TO BE MILDLY TO MODERATELY CALCIFIED. SEVERAL ATTEMPTS WERE MADE FOR THE SYSTEM TO CROSS THE RIGHT FEMORAL ACCESS SITE, BUT THE SYSTEM DID NOT CROSS THE ACCESS SITE. THIS DEVICE WAS REMOVED FROM THE PATIENT, RELEASED, INSPECTED, PREPARED, AND RELOADED WITH A SECOND FLEXNAV DELIVERY SYSTEM (9092349), AND A 14F NON-ABBOTT SHEATH WAS INSERTED AT THE ACCESS SITE. THERE WAS STILL DIFFICULTY DURING INSERTION AT THE RIGHT FEMORAL ACCESS SITE. IT WAS OBSERVED THAT ONE OF THE TABS ON CINE WAS MISALIGNED ONCE REACHING THE ANNULUS, WHICH WAS BELIEVED TO BE DUE TO THE DIFFICULTY WITH INSERTION FROM THE FEMORAL ACCESS POINT. THE VALVE WASN'T DEPLOYED AND WAS REMOVED FROM THE PATIENT. A NEW 25MM NAVITOR VALVE (19994657) AND FLEXNAV DELIVERY SYSTEM (9092349) WERE USED AND THE VALVE IMPLANTED WITH EXCELLENT RESULTS. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854882 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 9137581 05415067031587

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male