BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 23192386 · Received October 1, 2025

    Report

    Report Number
    2135147-2025-05560
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    January 1, 2024
    Report Date
    October 1, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DIABETES, SMOKING, OBSTRUCTIVE LUNG DISEASE, CHRONIC KIDNEY DISEASE, PRIOR CEREBROVASCULAR ACCIDENT, PRIOR TRANSIENT ISCHEMIC ATTACK, ATRIAL FIBRILLATION, HEART BLOCK, AND PACEMAKER. COMPLICATIONS REPORTED INCLUDED SURGICAL INTERVENTION (PACEMAKER, VALVE-IN-VALVE), STROKE, HEART BLOCK, MYOCARDIAL INFARCTION, AND PARAVALVULAR 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. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: SAFETY OF SAME-DAY DISCHARGE AFTER ELECTIVE TAVI WITH BALLOON- AND SELF-EXPANDING VALVES: A PROSPECTIVE SINGLE-CENTER UK STUDY.

    Description of Event or Problem · 0

    THE ARTICLE, "SAFETY OF SAME-DAY DISCHARGE AFTER ELECTIVE TAVI WITH BALLOON- AND SELF-EXPANDING VALVES: A PROSPECTIVE SINGLE-CENTER UK STUDY", WAS REVIEWED. THE ARTICLE PRESENTED A PROSPECTIVE, SINGLE CENTER STUDY TO COMPARE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PATIENTS WHO UNDERWENT SAME-DAY DISCHARGE (SDD) AND NON-SDD ACCORDING TO A PRE-DEFINED PROTOCOL. DEVICES INCLUDED IN THE STUDY WERE EVOLUT, NAVITOR, SAPIEN, OCTACOR, AND UNKNOWN. THE ARTICLE CONCLUDED THAT SDD TAVI IS A SAFE AND FEASIBLE APPROACH IN PATIENTS WHO UNDERWENT ELECTIVE UNEVENTFUL PROCEDURE, INCLUDING PATIENTS WHO RECEIVED SELF-EXPANDING VALVES. FUTURE STUDIES ARE REQUIRED TO SUPPORT THESE FINDINGS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MOHAMMAD ALKHALIL, DEPARTMENT OF CARDIOTHORACIC SERVICES, FREEMAN HOSPITAL, FREEMAN ROAD, NEWCASTLE-UPON-TYNE NE7 7DN, UNITED KINGDOM, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2024 TO JANUARY 2025. A TOTAL OF 289 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 40 (24%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 81 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED DIABETES, SMOKING, OBSTRUCTIVE LUNG DISEASE, CHRONIC KIDNEY DISEASE, PRIOR CEREBROVASCULAR ACCIDENT, PRIOR TRANSIENT ISCHEMIC ATTACK, ATRIAL FIBRILLATION, HEART BLOCK, AND PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837679 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL UNK NAVITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown