BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 23415879 · Received October 29, 2025

    Report

    Report Number
    2135147-2025-06193
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    September 1, 2017
    Report Date
    October 29, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 CORONARY ARTERY DISEASE, MITRAL VALVE REPLACEMENT, PREVIOUS CORONARY ARTERY BYPASS GRAFT (CABG), RIGHT BUNDLE BRANCH BLOCK (RBBB), LEFT BUNDLE BRANCH BLOCK (LBBB), ATRIAL FIBRILLATION, DIABETES MELLITUS, HYPERTENSION, PERMANENT PACEMAKER, RESPIRATORY INSUFFICIENCY, AND RENAL INSUFFICIENCY. COMPLICATIONS REPORTED INCLUDED DEATH, CARDIAC TAMPONADE, MYOCARDIAL INFARCTION, HEMATOMA, DISSECTION, PERICARDIAL EFFUSION, PSEUDOANEURYSM, CORONARY OBSTRUCTION, HEART BLOCK, BLEEDING, SURGICAL INTERVENTION (VALVE-IN-VALVE), SURGICAL INTERVENTION (PERMANENT PACEMAKER), SURGICAL INTERVENTION (NA), UNEXPECTED MEDICAL INTERVENTION (POST-BAV), UNEXPECTED MEDICAL INTERVENTION (TRANSFUSION), PERIVALVULAR LEAK; 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: COMPARATIVE ANALYSIS OF DIRECT ROUTINE LEFT VENTRICULAR GUIDEWIRE PACING AND RIGHT VENTRICULAR PACING: A FASTER AND SAFER APPROACH TO TAVR 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, "COMPARATIVE ANALYSIS OF DIRECT ROUTINE LEFT VENTRICULAR GUIDEWIRE PACING AND RIGHT VENTRICULAR PACING: A FASTER AND SAFER APPROACH TO TAVR", WAS REVIEWED. THIS ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE EFFICACY AND SAFETY OF ROUTINE LEFT VENTRICLE (LV) GUIDEWIRE PACING COMPARED TO RIGHT VENTRICLE (RV) PACING IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPAIR (TAVR). DEVICES MENTIONED IN THIS STUDY WERE EVOLUT R, ACURATE NEO, PORTICO, NAVITOR, SAPIEN XT, MYVAL, PERCLOSE PROGLIDE, PACEL BIPOLAR FLOW-DIRECTED CATHETER, SAFARI WIRE, CONFIDA WIRE, AND BACK-UP MEIER WIRE. THE ARTICLE CONCLUDED THAT ROUTINE LV PACING OFFERS SIGNIFICANT ADVANTAGES OVER RV PACING, INCLUDING REDUCED COMPLICATION RATES, SHORTER PROCEDURE TIMES AND GREATER EFFICIENCY. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ABDULLAH YILDIRIM, DEPARTMENT OF CARDIOLOGY, UNIVERSITY OF HEALTH SCIENCES, ADANA CITY TRAINING AND RESEARCH HOSPITAL, DR. MITHAT ÖZSAN ROAD NO. 1, ADANA, TURKEY, WITH CORRESPONDING EMAIL: [email protected].] THIS STUDY INCLUDED ALL PATIENTS WHO UNDERWENT TAVR FROM 01 SEPTEMBER 2017 TO 29 FEBRUARY 2024. A TOTAL OF 635 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 76.7 YEARS. THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED CORONARY ARTERY DISEASE, MITRAL VALVE REPLACEMENT, PREVIOUS CORONARY ARTERY BYPASS GRAFT (CABG), RIGHT BUNDLE BRANCH BLOCK (RBBB), LEFT BUNDLE BRANCH BLOCK (LBBB), ATRIAL FIBRILLATION, DIABETES MELLITUS, HYPERTENSION, PERMANENT PACEMAKER, RESPIRATORY INSUFFICIENCY, AND RENAL INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686608 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL UNK NAVITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability| R