BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 22541426 · Received July 18, 2025

    Report

    Report Number
    2135147-2025-03912
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    January 1, 2018
    Report Date
    July 29, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    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. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: PROJECTION SELECTION AND RAPID ATRIAL PACING IMPROVES EARLY OUTCOMES AFTER SELF-EXPANDING TRANSCATHETER AORTIC VALVES

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF PROJECTION SELECTION AND RAPID ATRIAL PACING IMPROVES EARLY OUTCOMES AFTER SELF-EXPANDING TRANSCATHETER AORTIC VALVES WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, DIABETES, ISCHEMIC HEART DISEASE, HEART FAILURE DECOMPENSATION, PRIOR STROKE/TRANSIENT ISCHEMIC ATTACK, ACTIVE NEOPLASIA, SYNCOPE, HEART BLOCK, ATRIAL FIBRILLATION. SOME OF THE COMPLICATIONS REPORTED WERE HEART BLOCK, STROKE, ATRIAL FIBRILLATION, HEART FAILURE, HEMORRHAGE; 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.

    Description of Event or Problem · 0

    THE ARTICLE, "PROJECTION SELECTION AND RAPID ATRIAL PACING IMPROVES EARLY OUTCOMES AFTER SELF-EXPANDING TRANSCATHETER AORTIC VALVES", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO DETERMINE WHETHER COMPARED TO CONVENTIONAL CARE, THE COMBINED USE OF CUSP OVERLAP PROJECTION (COP) AND RAPID ATRIAL PACING (RAP) CAN IMPROVE THE MANAGEMENT OF CONDUCTION DISTURBANCES AND THE EARLY OUTCOMES AFTER SELF-EXPANDABLE TRANSCATHETER AORTICVALVE IMPLANTATION (TAVI) PROCEDURES. DEVICES INCLUDED IN THE STUDY WERE EVOLUT PRO, PORTICO, AND NAVITOR. THE ARTICLE CONCLUDED THAT COMBINATION OF COP + RAP DURING SELF-EXPANDING TAVI IMPROVES POSTOPERATIVE SCREENING FOR CONDUCTION DISTURBANCES, THUS REDUCING THE NEED FOR CARDIAC RHYTHM MONITORING, AND THE LENGTH STAY. THE COP + RAP STRATEGY IMPROVES THE SHORT-TERM CLINICAL OUTCOMES OF SELF-EXPANDING TAVI DUE TO FEWER INFECTION-RELATED READMISSIONS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MARIA TAMARGO, DEPARTAMENTO DE CARDIOLOGÍA, HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN, INSTITUTO DE INVESTIGACIÓN SANITARIA GREGORIO MARAÑÓN, MADRID, SPAIN, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2018 TO JANUARY 2022. A TOTAL OF 273 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 109 (39.9%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 81 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HYPERTENSION, DIABETES, ISCHEMIC HEART DISEASE, HEART FAILURE DECOMPENSATION, PRIOR STROKE/TRANSIENT ISCHEMIC ATTACK, ACTIVE NEOPLASIA, SYNCOPE, HEART BLOCK, ATRIAL FIBRILLATION

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406537 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| H| S| L