BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVITOR VISION

    MDR report key: 24646198 · Received March 19, 2026

    Report

    Report Number
    2135147-2026-01743
    Event Type
    Death
    Date Received
    March 19, 2026
    Date of Event
    February 22, 2026
    Report Date
    March 19, 2026
    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 AORTIC DISSECTION, EMERGENCY SURGICAL INTERVENTION, BLEEDING, AND PATIENT DEATH DUE TO AN ACUTE TYPE A AORTIC DISSECTION WAS REPORTED. INFORMATION FROM FIELD INDICATED THAT THE PATIENT HAS HORIZONTAL ANATOMY MEASURING TO BE 75 DEGREES. AT 80 PERCENT THE VALVE WAS POSITIONED AT 1-2 MM AND WAS IMPLANTED AT A DEPTH OF 0 MM ON THE NON-CORONARY CUSP (NCC), SHALLOW THAN THE OPTIMAL DEPTH OF 3 MM AS RECOMMENDED IN INSTRUCTIONS FOR USE. THE DEVICE REMAINED IMPLANTED AND NOT RETURNED TO ABBOTT 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 LIMITED PROCEDURAL INFORMATION AVAILABLE AND MEDICAL REVIEW PERFORMED AT ABBOTT, THE EXACT CAUSE OF REPORTED PATIENT EFFECTS COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED DISSECTION, BLEEDING, AND PATIENT DEATH APPEAR TO BE CASCADING EVENTS. IT IS POSSIBLE THAT THE PROCEDURAL AND ANATOMICAL FACTORS (EXTREME HORIZONTAL ANGULATION) MAY HAVE CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. HOWEVER, THIS CANNOT BE CONFIRMED. THE INTERVENTION PERFORMED WAS ASSOCIATED WITH EMERGENCY SURGICAL INTERVENTION DUE TO DISSECTION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING, DESIGN, OR MANUFACTURING OF THE DEVICE. PLEASE NOTE THAT PER THE INSTRUCTIONS FOR USE, "TO MINIMIZE LIKELIHOOD OF PERMANENT PACEMAKER IMPLANTATION (PPI): MAINTAIN IMPLANT DEPTH OF 3 MM (IMPLANT DEPTH OF <3 MM COULD INCREASE RISK OF EMBOLIZATION), MAINTAIN AN IMPLANT DEPTH AT THE NON-CORONARY CUSP LESS THAN THE MEMBRANOUS SEPTUM LENGTH, AND LIMIT MANIPULATIONS ACROSS THE LVOT." CODES REMOVED: MEDICAL DEVICE PROBLEM CODE: 2993.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2026, A 25 MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE PATIENT HAS A PRIOR MEDICAL HISTORY SIGNIFICANT FOR CHRONIC HEART FAILURE, AORTIC VALVE STENOSIS, CHRONIC KIDNEY DISEASE (STAGE 3A¿3B), AND SYNCOPE, WITH A FUNCTIONAL CLASSIFICATION OF NYHA CLASS I. ADDITIONAL FINDINGS FROM 08 FEB. 2026, INCLUDE MILD AORTIC REGURGITATION, SEVERE MITRAL REGURGITATION, MILD TRICUSPID REGURGITATION, A RIGHT VENTRICULAR SYSTOLIC PRESSURE OF 41 MMHG, AND A LEFT VENTRICULAR EJECTION FRACTION OF 46%. THE PATIENT ALSO HAS A HORIZONTAL ANATOMY MEASURING TO BE 75 DEGREES. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 20 MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, AT 80 PERCENT, IT WAS POSITIONED AT 1-2 MM, AND THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 0 MM ON THE NON-CORONARY CUSP (NCC) AND 2 MM ON THE LEFT-CORONARY CUSP (LCC). POST-IMPLANT, A DISSECTION WAS OBSERVED FROM THE OUTFLOW FRAME OF THE NAVITOR VALVE AND EXTENDING RETROGRADELY UP TO THE VICINITY OF SINOTUBULAR JUNCTION (STJ); ANTEROGRADELY UP TO THE ARCH TOP. THE PATIENT WAS TRANSFERRED TO AN EMERGENCY SURGICAL INTERVENTION. ON (B)(6) 2026, THE IMPLANTER REPORTED THAT THE PATIENT'S BLEEDING COULD NOT BE CONTROLLED AND THE PATIENT WAS PRONOUNCED TO BE DECEASED DUE TO AN ACUTE TYPE A AORTIC DISSECTION. THE USER BELIEVES THE DEATH OCCURRED DUE TO THE PERFORMANCE OF THE ABBOTT PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE PATIENT HAS A PRIOR MEDICAL HISTORY SIGNIFICANT FOR CHRONIC HEART FAILURE, AORTIC VALVE STENOSIS, CHRONIC KIDNEY DISEASE (STAGE 3A¿3B), AND SYNCOPE, WITH A FUNCTIONAL CLASSIFICATION OF NYHA CLASS I. ADDITIONAL FINDINGS FROM (B)(6) 2026, INCLUDE MILD AORTIC REGURGITATION, SEVERE MITRAL REGURGITATION, MILD TRICUSPID REGURGITATION, A RIGHT VENTRICULAR SYSTOLIC PRESSURE OF 41 MMHG, AND A LEFT VENTRICULAR EJECTION FRACTION OF 46%. THE PATIENT ALSO HAS A HORIZONTAL ANATOMY MEASURING TO BE 75 DEGREES. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 20MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, AT 80 PERCENT, IT WAS POSITIONED AT 1-2MM, AND THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 0MM ON THE NON-CORONARY CUSP (NCC) AND 2MM ON THE LEFT-CORONARY CUSP (LCC). POST-IMPLANT, A DISSECTION WAS OBSERVED FROM THE OUTFLOW FRAME OF THE NAVITOR VALVE AND EXTENDING RETROGRADELY UP TO THE VICINITY OF SINOTUBULAR JUNCTION (STJ); ANTEROGRADELY UP TO THE ARCH TOP. THE PATIENT WAS TRANSFERRED TO AN EMERGENCY SURGICAL INTERVENTION. ON (B)(6) 2026. THE IMPLANTER REPORTED THAT THE PATIENT'S BLEEDING COULD NOT BE CONTROLLED AND THE PATIENT WAS PRONOUNCED TO BE DECEASED DUE TO AN ACUTE TYPE A AORTIC DISSECTION. THE USER BELIEVES THE DEATH OCCURRED DUE TO THE PERFORMANCE OF THE ABBOTT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707072 NAVITOR VISION AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL NVRO-25 11043806 05415067045782

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female Death| R