BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 22484540 · Received July 11, 2025

    Report

    Report Number
    2135147-2025-03816
    Event Type
    Death
    Date Received
    July 11, 2025
    Date of Event
    January 1, 2013
    Report Date
    July 30, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. B2: DATE OF DEATH IS ESTIMATED B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: SELF-EXPANDABLE TRANSCATHETER AORTIC VALVES IN PATIENTS WITH SMALL AORTIC ANNULUS: THE SWEDEHEART REGISTRY

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF SELF-EXPANDABLE TRANSCATHETER AORTIC VALVES IN PATIENTS WITH SMALL AORTIC ANNULUS: THE SWEDEHEART REGISTRY WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, DIABETES MELLITUS, CHRONIC KIDNEY DISEASE, AORTIC/MITRAL REGURGITATION, BICUSPID AORTIC VALVE. SOME OF THE COMPLICATIONS REPORTED WERE AORTIC VALVE STENOSIS, DEATH; 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. B2: DATE OF DEATH IS ESTIMATED. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE: SELF-EXPANDABLE TRANSCATHETER AORTIC VALVES IN PATIENTS WITH SMALL AORTIC ANNULUS: THE SWEDEHEART REGISTRY.

    Description of Event or Problem · 0

    THE ARTICLE, "SELF-EXPANDABLE TRANSCATHETER AORTIC VALVES IN PATIENTS WITH SMALL AORTIC ANNULUS: THE SWEDEHEART REGISTRY", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY TO COMPARE AN INTRA-ANNULAR SELF-EXPANDING VALVES (IA SEVS) TRANSCATHETER HEART VALVES (THVS) WITH CONTEMPORARY SUPRA-ANNULAR SELF-EXPANDING VALVES (SA SEVS) REGARDING MORTALITY OUTCOMES, DEVICE SUCCESS, TECHNICAL SUCCESS, AND HEMODYNAMIC PERFORMANCE. DEVICES INCLUDED IN THE STUDY WERE EVOLUT, ACURATE, PORTICO, AND NAVITOR. THE ARTICLE CONCLUDED THAT SA AND IA SEVS SHOW COMPARABLE CLINICAL OUTCOMES AND EXCELLENT HEMODYNAMIC PERFORMANCE IN PATIENTS WITH SMALL AORTIC ANNULI. FURTHER STUDIES, INCLUDING RANDOMIZED TRIALS, ARE NEEDED TO PROVIDE CLEARER GUIDANCE ON VALVE SELECTION. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ANTROS LOUCA, UNIVERSITY OF GOTHENBURG, DEPARTMENT OF MOLECULAR AND CLINICAL MEDICINE 41 345, GOTHENBURG, SWEDEN, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM 01 JANUARY 2013 TO 31 DECEMBER 2022. A TOTAL OF 1068 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 102 (9.6%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 81.2 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HYPERTENSION, DIABETES MELLITUS, CHRONIC KIDNEY DISEASE, AORTIC/MITRAL REGURGITATION, BICUSPID AORTIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948972 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL UNK NAVITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death