BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 23694574 · Received December 2, 2025

    Report

    Report Number
    2135147-2025-07060
    Event Type
    Death
    Date Received
    December 2, 2025
    Date of Event
    November 7, 2025
    Report Date
    January 21, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    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

    A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE ATTACHMENT: OUTCOMES OF HEMODIALYSIS PATIENTS UNDERGOING CONTEMPORARY TRANSCATHETER AORTIC VALVE IMPLANTATION. B2: DEATH DATE WAS ESTIMATED. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF NAVITOR DEVICE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HEART FAILURE, HYPERTENSION, DIABETES, CANCER, STROKE, CHRONIC OBSTRUCTIVE CORONARY DISEASE, ATRIAL FIBRILLATION, CAROTID ARTERY DISEASE, MITRAL REGURGITATION, TRICUSPID REGURGITATION, AND PRIOR MYOCARDIAL INFARCTION, PERCUTANEOUS CORONARY INTERVENTION, CORONARY ARTERY BYPASS GRAFT, AND CORONARY ARTERY DISEASE. COMPLICATIONS REPORTED INCLUDED DEATH, STROKE, RENAL FAILURE, ATRIAL FIBRILLATION, SURGICAL INTERVENTION (PACEMAKER IMPLANT), HOSPITALIZATION/PROLONGED HOSPITALIZATION; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. LITERATURE ATTACHMENT: OUTCOMES OF HEMODIALYSIS PATIENTS UNDERGOING CONTEMPORARY TRANSCATHETER AORTIC VALVE IMPLANTATION B3: EVENT DATE WAS ESTIMATED D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE ARTICLE, "OUTCOMES OF HEMODIALYSIS PATIENTS UNDERGOING CONTEMPORARY TRANSCATHETER AORTIC VALVE IMPLANTATION", WAS REVIEWED. THIS RESEARCH ARTICLE IS A PROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE SHORT- AND MID-TERM OUTCOMES OF TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN HEMODIALYSIS PATIENTS TO THOSE IN NON-HEMODIALYSIS PATIENTS AND STRATIFY THE RISK OF ALL-CAUSE MORTALITY AFTER TAVI IN HEMODIALYSIS PATIENTS. THE DEVICES INCLUDED IN THIS STUDY WERE NAVITOR, NAVITOR VISION, SAPIEN3, SAPIEN3 ULTRA RESILIA, EVOLUT R, EVOLUT PRO, EVOLUT PRO+, AND EVOLUT FX. THE ARTICLE CONCLUDED THAT MID-TERM ALL-CAUSE AND MORTALITY AND HEART FAILURE HOSPITALIZATION WERE MORE FREQUENTLY OBSERVED IN HEMODIALYSIS PATIENTS. HEMODIALYSIS ITSELF WAS NOT ASSOCIATED WITH ALL-CAUSE MORTALITY OR THE COMPOSITE OUTCOME. [THE PRIMARY AND CORRESPONDING AUTHOR WAS RYOSUKE HIGUCHI, DEPARTMENT OF CARDIOLOGY, SAKAKIBARA HEART INSTITUTE, 3-16-1 ASAHICHO, FUCHU, TOKYO 183-0003, JAPAN, WITH CORRESPONDING EMAIL: [email protected].]. THIS STUDY INCLUDED PATIENTS WHO UNDERWENT TAVI BETWEEN 01 JANUARY 2021 TO 31 DECEMBER 2024. A TOTAL OF 2,888 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 85 YEARS OLD. THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HEART FAILURE, HYPERTENSION, DIABETES, CANCER, STROKE, CHRONIC OBSTRUCTIVE CORONARY DISEASE, ATRIAL FIBRILLATION, CAROTID ARTERY DISEASE, MITRAL REGURGITATION, TRICUSPID REGURGITATION, AND PRIOR MYOCARDIAL INFARCTION, PERCUTANEOUS CORONARY INTERVENTION, CORONARY ARTERY BYPASS GRAFT, AND CORONARY ARTERY DISEASE.

    Description of Event or Problem · 0

    THE ARTICLE, "OUTCOMES OF HEMODIALYSIS PATIENTS UNDERGOING CONTEMPORARY TRANSCATHETER AORTIC VALVE IMPLANTATION", WAS REVIEWED. THIS RESEARCH ARTICLE IS A PROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE SHORT- AND MID-TERM OUTCOMES OF TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN HEMODIALYSIS PATIENTS TO THOSE IN NON-HEMODIALYSIS PATIENTS AND STRATIFY THE RISK OF ALL-CAUSE MORTALITY AFTER TAVI IN HEMODIALYSIS PATIENTS. THE DEVICES INCLUDED IN THIS STUDY WERE NAVITOR, NAVITOR VISION, SAPIEN3, SAPIEN3 ULTRA RESILIA, EVOLUT R, EVOLUT PRO, EVOLUT PRO+, AND EVOLUT FX. THE ARTICLE CONCLUDED THAT MID-TERM ALL-CAUSE AND MORTALITY AND HEART FAILURE HOSPITALIZATION WERE MORE FREQUENTLY OBSERVED IN HEMODIALYSIS PATIENTS. HEMODIALYSIS ITSELF WAS NOT ASSOCIATED WITH ALL-CAUSE MORTALITY OR THE COMPOSITE OUTCOME. [THE PRIMARY AND CORRESPONDING AUTHOR WAS RYOSUKE HIGUCHI, DEPARTMENT OF CARDIOLOGY, SAKAKIBARA HEART INSTITUTE, 3-16-1 ASAHICHO, FUCHU, TOKYO 183-0003, JAPAN, WITH CORRESPONDING EMAIL: [email protected].] THIS STUDY INCLUDED PATIENTS WHO UNDERWENT TAVI BETWEEN 01 JANUARY 2021 TO 31 DECEMBER 2024. A TOTAL OF 2,888 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 85 YEARS OLD. THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HEART FAILURE, HYPERTENSION, DIABETES, CANCER, STROKE, CHRONIC OBSTRUCTIVE CORONARY DISEASE, ATRIAL FIBRILLATION, CAROTID ARTERY DISEASE, MITRAL REGURGITATION, TRICUSPID REGURGITATION, AND PRIOR MYOCARDIAL INFARCTION, PERCUTANEOUS CORONARY INTERVENTION, CORONARY ARTERY BYPASS GRAFT, AND CORONARY ARTERY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2736093 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL UNK NAVITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death