BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 22289869 · Received June 19, 2025

    Report

    Report Number
    2135147-2025-03296
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    January 1, 2016
    Report Date
    July 25, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF COMPARISON BETWEEN SEVERE R-L AND R-NC RAPHE-TYPE BICUSPID AORTIC VALVE STENOSIS TREATED WITH TAVI: INSIGHTS FROM THE INTERNATIONAL AD HOC REGISTRY WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ARTERIAL HYPERTENSION, DIABETES MELLITUS, PRIOR PACEMAKER, CORONARY ARTERY DISEASE, PERIPHERAL ARTERIAL DISEASE, ATRIAL FIBRILLATION, PRIOR STROKE, TRANSIENT ISCHEMIC ATTACK, CHRONIC OBSTRUCTIVE PULMONARY DISEASE.. SOME OF THE COMPLICATIONS REPORTED WERE MYOCARDIAL INFARCTION, STROKE, HEMORRHAGE, RENAL FAILURE, HEART FAILURE, REGURGITATION; 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. CODES REMOVED: MEDICAL DEVICE PROBLEM CODE: 1457 PERIVALVULAR LEAK. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: COMPARISON BETWEEN SEVERE R-L AND R-NC RAPHE-TYPE BICUSPID AORTIC VALVE STENOSIS TREATED WITH TAVI: INSIGHTS FROM THE INTERNATIONAL AD HOC REGISTRY.

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THE ARTICLE, "COMPARISON BETWEEN SEVERE R-L AND R-NC RAPHE-TYPE BICUSPID AORTIC VALVE STENOSIS TREATED WITH TAVI: INSIGHTS FROM THE INTERNATIONAL AD HOC REGISTRY", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY TO COMPARE CLINICAL AND PROCEDURAL OUTCOMES IN PATIENTS WITH TYPE 1 BICUSPID AORTIC VALVE (BAV), FOCUSING ON THOSE WITH RIGHT-LEFT (R-L) AND RIGHT-NON CORONARY (R-NC) CUSP FUSION. DEVICES INCLUDED IN THE STUDY WERE EVOLUT R, PORTICO, VENUS A PLUS, ACURATE NEO, SAPIEN 3, NAVITOR, MYVAL, TAURUS VALVE, PRIZVALVE, ACURATE NEO2, SAPIEN 3 ULTRA, AND EVOLUT PRO/PRO+. THE ARTICLE CONCLUDED RAPHE LOCALIZATION IN SIEVERS TYPE 1 BAV DOES NOT AFFECT MAJOR TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) OUTCOMES EXCEPT FOR PERMANENT PACEMAKER IMPLANTATION (PPI) RISK, WHICH IS 3-FOLD HIGHER IN R-L PATIENTS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ANDREA BUONO, VALVE CENTER, FONDAZIONE POLIAMBULANZA, VIA BISSOLATI 57, 24125, BRESCIA, ITALY, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2016 TO OCTOBER 2023. A TOTAL OF 956 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 50 (5.2%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 78 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED ARTERIAL HYPERTENSION, DIABETES MELLITUS, PRIOR PACEMAKER, CORONARY ARTERY DISEASE, PERIPHERAL ARTERIAL DISEASE, ATRIAL FIBRILLATION, PRIOR STROKE, TRANSIENT ISCHEMIC ATTACK, CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865615 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| S| H| L