BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTICO TRANSCATHETER AORTIC VALVE

    MDR report key: 19424872 · Received May 30, 2024

    Report

    Report Number
    2135147-2024-02468
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    December 1, 2016
    Report Date
    May 30, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF PORTICO VALVES WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSIONS, DIABETES, DYSLIPIDEMIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CORONARY ARTERY DISEASE, PRIOR CORONARY ARTERY BYPASS GRAFT, PRIOR ACUTE MYOCARDIAL INFARCTION, PRIOR ATRIAL FIBRILLATION, AORTIC STENOSIS AND AORTIC REGURGITATION. SOME OF THE COMPLICATIONS REPORTED WERE SURGICAL INTERVENTION (PACEMAKER), UNEXPECTED MEDICAL INTERVENTION (POST-BAV), STROKE, AND PARAVALVULAR LEAK. 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. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLE "ANGULATION AND CURVATURE OF AORTIC LANDING ZONE AFFECT IMPLANTATION DEPTH IN TRANSCATHETER AORTIC VALVE IMPLANTATION"

    Description of Event or Problem · 0

    THE ARTICLE, "ANGULATION AND CURVATURE OF AORTIC LANDING ZONE AFFECT IMPLANTATION DEPTH IN TRANSCATHETER AORTIC VALVE IMPLANTATION", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY ON THE THE IMPACT OF AORTIC LANDING ZONE (LZ) CURVATURE AND ANGULATION ON TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IMPLANTATION DEPTH, COMPARING SHORT-FRAME BALLOON-EXPANDING (BE) AND LONG-FRAME SELF-EXPANDING (SE) DEVICES. DEVICES INCLUDED IN THE STUDY WERE MYVAL, SAPIEN 3, EVOLUT PRO/R, AND PORTICO. THE ARTICLE CONCLUDED THAT AORTIC LZ CURVATURE AND ANGULATION SIGNIFICANTLY AFFECTED FINAL TAVI IMPLANTATION DEPTH, ESPECIALLY IN HIGH STENT-FRAME SE DEVICES REPORTING, UPON COMPLETE RELEASE, DEEPER IMPLANTATION DEPTH WITH RESPECT TO THE INTENDED ONE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS RICCARDO GORLA, DEPARTMENT OF CLINICAL AND INTERVENTIONAL CARDIOLOGY, IRCCS POLICLINICO SAN DONATO, P.ZZA EDMONDO MALAN 2, 20097 SAN DONATO MILANESE, MILAN, ITALY, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM DECEMBER 2016 TO SEPTEMBER 2021. A TOTAL OF 202 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 26 (12.9%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 81 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED HYPERTENSIONS, DIABETES, DYSLIPIDEMIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CORONARY ARTERY DISEASE, PRIOR CORONARY ARTERY BYPASS GRAFT, PRIOR ACUTE MYOCARDIAL INFARCTION, PRIOR ATRIAL FIBRILLATION, AORTIC STENOSIS, AORTIC REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423387 PORTICO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown