BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 25322500 · Received May 28, 2026

    Report

    Report Number
    2135147-2026-03620
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    June 1, 2022
    Report Date
    May 28, 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

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF NAVITOR VALVE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING SEVERE AORTIC STENOSIS AND MODERATE OR SEVERE LEFT VENTRICULAR OUTFLOW TRACT CALCIFICATION. COMPLICATIONS REPORTED INCLUDED DEVICE MIGRATION/EMBOLIZATION, SECOND VALVE IMPLANT; 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. LITERATURE ATTACHMENT: INCIDENCE AND PREDICTORS OF VALVE POP-UP DURING NAVITOR 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, "INCIDENCE AND PREDICTORS OF VALVE POP-UP DURING NAVITOR VALVE IMPLANTATION", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE-CENTER EXPERIENCE TO EVALUATE THE INCIDENCE OF VALVE POP-UP DURING NAVITOR TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) AND TO IDENTIFY PROCEDURAL AND ANATOMICAL PREDICTORS ASSOCIATED WITH THE PHENOMENON. THE DEVICE INCLUDED IN THE STUDY WAS NAVITOR/NAVITOR VISION. THE ARTICLE CONCLUDED THAT VALVE POP-UP OCCURRED IN 19% OF PATIENTS. INCONSISTENT VALVE DEPTH AND SEVERE LEAFLET CALCIFICATION WERE PREDICTORS OF VALVE POP-UP. [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 E-MAIL: [email protected].] THIS STUDY INCLUDED PATIENTS WITH SEVERE AORTIC STENOSIS WHO UNDERWENT TAVI WITH THE NAVITOR OR NAVITOR VISION FROM 01 JUNE 2022 TO 31 MARCH 2025. A TOTAL OF 67 PATIENTS WERE INCLUDED IN THE STUDY, ALL OF WHICH RECEIVED AN ABBOTT DEVICE. THE MEDIAN AGE WAS 85 YEARS. THE MAJORITY GENDER WAS UNKNOWN. COMORBIDITIES INCLUDED SEVERE AORTIC STENOSIS AND MODERATE OR SEVERE LEFT VENTRICULAR OUTFLOW TRACT CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545851 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL UNK NAVITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention