BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR VISION

    MDR report key: 19843686 · Received July 26, 2024

    Report

    Report Number
    2135147-2024-03641
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    July 3, 2024
    Report Date
    July 26, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067045782
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF OBSTRUCTION/OCCLUSION POST PROCEDURE WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE AND WAS NOT RETURNED FOR ANALYSIS. POSSIBLE CAUSES OF DEVICE OBSTRUCTION/OCCLUSION INCLUDE DEVICE OVERSIZING AND SUBOPTIMAL IMPLANT DEPTH. THE CORRECT VALVE SIZE WAS USED AS PER THE INSTRUCTION FOR USE (IFU). FINAL IMPLANT 2MM AT NON-CORONARY CUSP AND 1MM AT LEFT CORONARY CUSP. 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. HOWEVER, SUBOPTIMAL IMPLANT DEPTH COULD CONTRIBUTE TO THE OBSTRUCTION OF THE CORONARY ARTERIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 25M NAVITOR VISON VALVE WAS CHOSEN FOR A PROCEDURE USING A SMALL FLEXNAV DELIVERY SYSTEM. THE PERIMETER OF THE ANNULUS WAS 71.1MM. THE VALVE WAS IMPLANTED AT A DEPTH OF 2MM AT NON-CORONARY CUSP AND 1MM AT LEFT CORONARY CUSP. THE DAY AFTER THE SURGERY, THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND A CORONARY OCCLUSION WAS NOTED. AN AORTIC VALVE REPLACEMENT (AVR) WAS PERFORMED AND NAVITOR VALVE WAS EXPLANTED. THE PATIENT WAS REPORTED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528920 NAVITOR VISION AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 10246626 05415067045782

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention