BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 20427127 · Received October 11, 2024

    Report

    Report Number
    2135147-2024-05000
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    January 1, 2016
    Report Date
    November 22, 2024
    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

    B3 - DATE OF EVENT IS ESTIMATED. D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED LITERATURE ATTACHMENT: ARTICLE TITLE "CHARACTERISTICS, SIZING AND OUTCOMES OF STENOTIC, TAPERED, RAPHE-TYPE BICUSPID AORTIC VALVES TREATED WITH TRANS-CATHETER DEVICE IMPLANTATION_INSIGHTS THE AD HOC REGISTRY" INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF NAVITOR VALVE PROCEDURE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ARTERIAL HYPERTENSION, DIABETES MELLITUS, PRIOR PACEMAKER IMPLANTATION, CORONARY ARTERY DISEASE, PERIPHERAL ARTERY DISEASE, CAROTID ARTERY DISEASE, ATRIAL FIBRILLATION, HISTORY OF STROKE, HISTORY OF TRANSIENT ISCHEMIC ATTACK, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HEART FAILURE, HEART BLOCK, AND BICUSPID AORTIC VALVE. SOME OF THE COMPLICATIONS REPORTED WERE PERIVALVULAR LEAK, OFF-LABEL USE, STRUCTURAL VALVE DETERIORATION, MYOCARDIAL INFARCTION, STROKE, HEMORRHAGE, RENAL FAILURE, HEART FAILURE, AORTIC VALVE INSUFFICIENCY, VASCULAR DISSECTION, POST-IMPLANT VALVULOPLASTY, PERMANENT PACEMAKER IMPLANTATION, AND VALVE-IN-VALVE IMPLANTATION; 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. PLEASE NOTE THAT, PER THE INSTRUCTIONS FOR USE, "CONTRAINDICATIONS: THE VALVE IS CONTRAINDICATED FOR PATIENTS WITH ANY LEAFLET CONFIGURATION OTHER THAN TRICUSPID.¿ B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLE: CHARACTERISTICS, SIZING AND OUTCOMES OF STENOTIC, TAPERED, RAPHE-TYPE BICUSPID AORTIC VALVES TREATED WITH TRANS-CATHETER DEVICE IMPLANTATION_INSIGHTS THE AD HOC REGISTRY.

    Description of Event or Problem · 0

    THE ARTICLE, "CHARACTERISTICS, SIZING AND OUTCOMES OF STENOTIC, TAPERED, RAPHE-TYPE BICUSPID AORTIC VALVES TREATED WITH TRANS-CATHETER DEVICE IMPLANTATION_INSIGHTS THE AD HOC REGISTRY", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY TO DESCRIBE THE PHENOTYPICAL CHARACTERISTICS OF SEVERE, TAPERED, RAPHE-TYPE, BICUSPID AORTIC VALVE (BAV) STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) AND TO EXPLORE SAFETY AND EFFICACY OF MODERN-GENERATION TRANSCATHETER HEART VALVES (THVS), ANALYZING THE IMPACT OF ANNULAR AND SUPRA-ANNULAR SIZING STRATEGIES ON SHORT- AND MID-TERMS OUTCOMES. DEVICES INCLUDED IN THE STUDY WERE EVOLUT R, EVOLUT PRO/PRO+, PORTICO, NAVITOR, VENUS A PLUS, ACURATE NEO/NEO 2, SAPIEN 3/3 ULTRA, LOTUS EDGE, MYVAL, TAURUS VALVE, PRIZVALVE. THE ARTICLE CONCLUDED TAVR WITH MODERN-GENERATION DEVICES IS SAFE AND EFFECTIVE FOR TAPERED RAPHE-TYPE BAV, SHOWING COMPARABLE RESULTS FOR ANNULAR AND SUPRA-ANNULAR SIZING STRATEGIES. [THE PRIMARY AUTHOR WAS ANDREA BUONO, VALVE CENTER, FONDAZIONE POLIAMBULANZA ISTITUTO OSPEDALIERO, BRESCIA, ITALY. THE CORRESPONDING AUTHOR WAS GIUSEPPE TARANTINI, DEPARTMENT OF CARDIAC, THORACIC, VASCULAR SCIENCES AND PUBLIC HEALTH, UNIVERSITY OF PADUA, VIA GIUSTINIANI 2, 35128 PADOVA, ITALY, WITH CORRESPONDING EMAIL [email protected]] THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2016 TO JUNE 2023. A TOTAL OF 696 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 38 (5.5%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 78.0 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED ARTERIAL HYPERTENSION, DIABETES MELLITUS, PRIOR PACEMAKER IMPLANTATION, CORONARY ARTERY DISEASE, PERIPHERAL ARTERY DISEASE, CAROTID ARTERY DISEASE, ATRIAL FIBRILLATION, HISTORY OF STROKE, HISTORY OF TRANSIENT ISCHEMIC ATTACK, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HEART FAILURE, HEART BLOCK, AND BICUSPID AORTIC VALVE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301234 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| S| R| L