BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVITOR VISION

    MDR report key: 24716486 · Received March 30, 2026

    Report

    Report Number
    2135147-2026-01977
    Event Type
    Death
    Date Received
    March 30, 2026
    Date of Event
    March 4, 2026
    Report Date
    May 8, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067045799
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 OF VALVE MIGRATION, CORONARY OCCLUSION, AND DEATH WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND 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 AND MEDICAL REVIEW, THE CAUSE FOR THE REPORTED VALVE MIGRATION IS LIKELY DUE TO CALCIFICATION, HOWEVER THIS CANNOT BE DETERMINED. THE REPORTED CORONARY OCCLUSION IS A CASCADING EFFECT FROM THE EVENT. THE REPORTED DEATH IS LIKELY RELATED TO THE CORONARY OCCLUSION. 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) 2026, A 27MM NAVITOR VISION VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT'S AORTIC VALVE ANGLE (AV ANGLE FROM 3MENSIO) WAS 37º. THERE WAS A NODULE OF CONCENTRATED CALCIUM BETWEEN THE NON-CORONARY SINUS (NCS) AND RIGHT CORONARY SINUS (RCS). DURING PROCEDURE, A PRE-DILATION WAS PERFORMED WITH A 22MM NON-ABBOTT BALLOON. THE VALVE DEPTH WAS 4-5 MM AND IT GOT MIGRATED TOWARDS AORTA. THE REASON FOR THE MIGRATION WAS THE CALCIUM NODULE THAT HAD TO DISPLACE THE VALVE UPWARDS DURING THE RELEASE. THEY DECIDED TO INSERT A NEW 27MM NAVITOR VISION VALVE AND, DESPITE RECOMMENDATIONS TO PULL OUT THE FIRST ONE WITH A LOOP, THE DOCTORS DECIDED NOT TO MOVE IT DUE TO PATIENT CONDITION AND TO INSERT THE SECOND ONE, CAUSING A CORONARY OCCLUSION AND RESULTING IN THE PATIENT'S DEATH. THE CAUSE OF DEATH WAS BLOCK THE LEFT CORONARY ARTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2026, A 27MM NAVITOR VISION VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT'S AORTIC VALVE ANGLE (AV ANGLE FROM 3MENSIO) WAS 37º. THERE WAS A NODULE OF CONCENTRATED CALCIUM BETWEEN THE NON-CORONARY SINUS (NCS) AND RIGHT CORONARY SINUS (RCS). DURING PROCEDURE, A PRE-DILATION WAS PERFORMED WITH A 22 MM NON-ABBOTT BALLOON. THE VALVE DEPTH WAS 4-5 MM AND IT GOT MIGRATED TOWARDS AORTA. THE REASON FOR THE MIGRATION WAS THE CALCIUM NODULE THAT HAD TO DISPLACE THE VALVE UPWARDS DURING THE RELEASE. THEY DECIDED TO INSERT A NEW 27 MM NAVITOR VISION VALVE AND, DESPITE RECOMMENDATIONS TO PULL OUT THE FIRST ONE WITH A LOOP, THE DOCTORS DECIDED NOT TO MOVE IT DUE TO PATIENT CONDITION AND TO INSERT THE SECOND ONE, CAUSING A CORONARY OCCLUSION AND RESULTING IN THE PATIENT'S DEATH. THE CAUSE OF DEATH WAS BLOCK THE LEFT CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37346 NAVITOR VISION AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL NVRO-27 11076919 05415067045799

    Patients

    Seq Age Sex Outcome Treatment
    1