BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTICO TRANSCATHETER AORTIC VALVE

    MDR report key: 22790129 · Received August 12, 2025

    Report

    Report Number
    2135147-2025-04491
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    April 1, 2020
    Report Date
    August 12, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF NON-INVASIVE MYOCARDIAL WORK AS AN INDEPENDENT PREDICTOR OF POSTPROCEDURAL NT-PROBNP IN ELDERLY PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ANGINA, SYNCOPE, DYSPNEA, HYPERTENSION, DIABETES MELLITUS, ATRIAL FIBRILLATION, ISCHEMIC HEART DISEASE, PRIOR REVASCULARIZATION, PERIPHERAL ARTERY DISEASE, CHRONIC KIDNEY DISEASE, CARDIAC IMPLANTABLE ELECTRONIC DEVICE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, STROKE, HYPOTHYREOSIS, AORTIC STENOSIS, LOW-FLOW GRADIENT. ONE OF THE COMPLICATION REPORTED WAS AORTIC VALVE INSUFFICIENCY/ REGURGITATION; THIS COMPLICATION IS 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. B3: DATE OF EVENT IS ESTIMATED D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE REVIEW: NON-INVASIVE MYOCARDIAL WORK AS AN INDEPENDENT PREDICTOR OF POSTPROCEDURAL NT-PROBNP IN ELDERLY PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT.

    Description of Event or Problem · 0

    THE ARTICLE, "NON-INVASIVE MYOCARDIAL WORK AS AN INDEPENDENT PREDICTOR OF POSTPROCEDURAL NT-PROBNP IN ELDERLY PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT", WAS REVIEWED. THE ARTICLE PRESENTED A PROSPECTIVE, SINGLE-CENTER STUDY TO EVALUATE THE MYOCARDIAL WORK INDICES OF SEVERE AORTIC VALVE STENOSIS (AS) PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), AND TO EXPLORE THE PREDICTIVE VALUE OF PREOPERATIVE MYOCARDIAL WORK REGARDING THE POSTOPERATIVE STATUS OF THE PATIENTS, WITH THE POSTOPERATIVE N-TERMINAL PROHORMONE OF BRAIN NATRIURETIC PEPTIDE (NTPROBNP) LEVELS SERVING AS THE ENDPOINT. DEVICES INCLUDED IN THE STUDY WERE COREVALVE/EVOLUTR/EVOLUTPRO (MEDTRONIC), PORTICO (ABBOTT), AND ACURATE NEO/ACURATE NEO 2 (BOSTON SCIENTIFIC). THE ARTICLE CONCLUDED THAT GLOBAL LONGITUDINAL STRAIN (GLS), GLOBAL MYOCARDIAL WORK INDEX (GWI) AND GLOBAL CONSTRUCTIVE WORK (GCW) CHANGED AFTER TAVR WHILE THERE WAS NO ALTERATION IN EJECTION FRACTION (EF). THE PREPROCEDURAL GCW AND HISTORY OF ATRIAL FIBRILLATION (AF) WERE INDEPENDENT PREDICTORS OF POSTPROCEDURAL NT-PROBNP. ACCORDINGLY, MYOCARDIAL WORK INDICES MAY HELP PATIENT SELECTION AND THE PREDICTION OF THE FUNCTIONAL OUTCOME IN THIS POPULATION. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ZSUZSANNA LADÁNYI, HEART AND VASCULAR CENTER, SEMMELWEIS UNIVERSITY, BUDAPEST, HUNGARY, WITH CORRESPONDING E-MAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM APRIL 2020 TO MARCH 2021. A TOTAL OF 90 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 35 (39%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 80 YEARS OLD, THE AVERAGE WEIGHT WAS 78KG, AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED ANGINA, SYNCOPE, DYSPNEA, HYPERTENSION, DIABETES MELLITUS, ATRIAL FIBRILLATION, ISCHEMIC HEART DISEASE, PRIOR REVASCULARIZATION, PERIPHERAL ARTERY DISEASE, CHRONIC KIDNEY DISEASE, CARDIAC IMPLANTABLE ELECTRONIC DEVICE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, STROKE, HYPOTHYREOSIS, AORTIC STENOSIS, LOW-FLOW GRADIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75782 PORTICO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL UNK PORTICO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown