BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 24744305 · Received March 31, 2026

    Report

    Report Number
    2135147-2026-02052
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    January 1, 2008
    Report Date
    March 31, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 HYPERTENSION, DIABETES, DYSLIPIDEMIA, AND PERIPHERAL ARTERY DISEASE. COMPLICATIONS REPORTED INCLUDED PATIENT DEVICE INTERACTION PROBLEM, STROKE, MYOCARDIAL INFARCTION, THROMBUS, SURGICAL INTERVENTION (VALVE-IN-VALVE), UNEXPECTED MEDICAL INTERVENTION (POST-BALLOON AORTIC VALVULOPLASTY), HOSPITALIZATION/PROLONGED-HOSPITALIZATION; 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: IMPACT OF VALVE FRAME HEIGHT ON PCI OUTCOMES AFTER 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, "IMPACT OF VALVE FRAME HEIGHT ON PCI OUTCOMES AFTER TAVR", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE IMPACT OF BIOPROSTHETIC AORTIC VALVE TYPE ON LONG-TERM CLINICAL OUTCOMES IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI). THE DEVICES INCLUDED IN THE STUDY WERE SAPIEN VALVES, COREVALVE, EVOLUT, SYMATIS, ACURATE, AND PORTICO/NAVITOR. THE ARTICLE CONCLUDED THAT LONG-TERM OUTCOMES AFTER PCI IN TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PATIENTS DO NOT APPEAR TO BE SIGNIFICANTLY DIFFERENT BETWEEN THOSE RECEIVING SHORT-FRAMED VALVES (SFV) AND TAIL-FRAMED VALVES (TFV). [THE PRIMARY AND CORRESPONDING AUTHOR WAS GIULIO STEFANINI, IRCCS HUMANITAS RESEARCH HOSPITAL, VIA ALESSANDRO MANZONI, 56, 20089 ROZZANO, MILAN, ITALY, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED PATIENTS WHO UNDERWENT PCI AFTER TAVR FROM 01 JANUARY 2008 TO 31 DECEMBER 2023. A TOTAL OF 441 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 2.9% (13) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE OF THE SHORT-FRAMED VALVE GROUP WAS 80.7 YEARS. THE AVERAGE AGE OF THE TAIL-FRAME VALVE GROUP WAS 81.1 YEARS. THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED HYPERTENSION, DIABETES, DYSLIPIDEMIA, AND PERIPHERAL ARTERY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800720 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL UNK NAVITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| S| R| H