BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR VISION

    MDR report key: 22346654 · Received June 27, 2025

    Report

    Report Number
    2135147-2025-03479
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    June 2, 2025
    Report Date
    July 29, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067045799
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 STROKE POST-IMPLANT 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. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED STROKE COULD NOT BE CONCLUSIVELY DETERMINED. IT IS POSSIBLE PROCEDURAL CONDITION CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, THIS CANNOT BE CONFIRMED. THE REPORTED SURGICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES AS A PERMANENT PACEMAKER WAS IMPLANTED. 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) 2025, A 27MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). A PRE-BAV WAS PERFORMED USING A 22MM NON-ABBOTT BALLOON. THE VALVE WAS SUCCESSFULLY IMPLANTED, BUT WHILE REMOVING THE DS AT THE END OF THE PROCEDURE, IT WAS UNABLE TO BE REMOVED FROM THE OVER THE NON-ABBOTT GUIDEWIRE. THE PHYSICIAN USED A PAIR OF SCISSORS TO CUT THE WIRE TO RESOLVE THE EVENT. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. AT AN UNKNOWN DATE THE PATIENT HAD A STROKE AND REQUIRED A PACEMAKER IMPLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, A 27 MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). A PRE-BAV WAS PERFORMED USING A 22 MM NON-ABBOTT BALLOON. THE VALVE WAS SUCCESSFULLY IMPLANTED, BUT WHILE REMOVING THE DS AT THE END OF THE PROCEDURE, IT WAS UNABLE TO BE REMOVED FROM THE OVER THE NON-ABBOTT GUIDEWIRE. THE PHYSICIAN USED A PAIR OF SCISSORS TO CUT THE WIRE TO RESOLVE THE EVENT. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. AT AN UNKNOWN DATE THE PATIENT HAD A STROKE AND REQUIRED A PACEMAKER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003855 NAVITOR VISION AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL NVRO-27 10359816 05415067045799

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| S