BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR VISION

    MDR report key: 23322904 · Received October 17, 2025

    Report

    Report Number
    2135147-2025-05886
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 18, 2025
    Report Date
    November 14, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067045782
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT FOR PATIENT EFFECTS OF HEART BLOCK 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 INVESTIGATION WAS UNABLE TO DETERMINE THE CAUSE FOR THE REPORTED HEART BLOCK. THE REPORTED SURGICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. 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

    CLINICAL INFORMATION: (B)(4) - ENVISION IDE STUDY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM NAVITOR VISION VALVE WAS CHOSEN FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A SMALL FLEXNAV DELIVERY SYSTEM. DURING PROCEDURE, THE ACTIVATED CLOTTING LEVELS (ACT) WERE 122-267-116S AND HEPARIN WAS ADMINISTERED. A PRE-IMPLANT BALLOON VALVULOPLASTY DONE WITH A 22MM NON-ABBOTT BALLOON. DURING DEPLOYMENT, A INTRAPROCEDURAL COMPLETE HEART BLOCK (CHB) AND NEW LEFT BUNDLE BRANCH BLOCK (LBBB) WERE NOTED. THE PATIENT REQUIRED UNPLANNED IN-PATIENT HOSPITALIZATION. ON (B)(6) 2025, A SINGLE CHAMBER PACEMAKER WAS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 0

    CLINICAL INFORMATION: (B)(6) - ENVISION IDE STUDY, PATIENT SITE ID: (B)(6) (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM NAVITOR VISION VALVE WAS CHOSEN FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A SMALL FLEXNAV DELIVERY SYSTEM. DURING PROCEDURE, THE ACTIVATED CLOTTING LEVELS (ACT) WERE 122-267-116S AND HEPARIN WAS ADMINISTERED. A PRE-IMPLANT BALLOON VALVULOPLASTY DONE WITH A 22MM NON-ABBOTT BALLOON. DURING DEPLOYMENT, A INTRAPROCEDURAL COMPLETE HEART BLOCK (CHB) AND NEW LEFT BUNDLE BRANCH BLOCK (LBBB) WERE NOTED. THE PATIENT REQUIRED UNPLANNED IN-PATIENT HOSPITALIZATION. ON (B)(6) 2025, A SINGLE CHAMBER PACEMAKER WAS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298482 NAVITOR VISION AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL NVRO-25 10815992 05415067045782

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention| H