BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTICO TRANSCATHETER AORTIC VALVE

    MDR report key: 17996332 · Received October 24, 2023

    Report

    Report Number
    2135147-2023-04624
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    September 1, 2021
    Report Date
    October 24, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF PORTICO VALVE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING DIABETES MELLITUS, CHRONIC DIALYSIS USE, CHRONIC LUNG DISEASE, PERIPHERAL ARTERIAL DISEASE, CEREBROVASCULAR DISEASE AND PRIOR MYOCARDIAL INFARCTION. SOME OF THE COMPLICATIONS REPORTED WERE PERMANENT PACEMAKER IMPLANT (SURGICAL INTERVENTION), STROKE AND PATIENT DEATH 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.

    Description of Event or Problem · 0

    THE ARTICLE, "SELF-EXPANDING TRANSCATHETER AORTIC VALVES OPTIMIZE TRANSVALVULAR HEMODYNAMICS INDEPENDENT OF INTRA- VERSUS SUPRA-ANNULAR DESIGN", WAS REVIEWED. THE ARTICLE PRESENTED A PROSPECTIVE, SINGLE CENTER STUDY TO CHARACTERIZE TRANSVALVULAR HEMODYNAMICS DURING THE FIRST 30 DAYS AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) ACROSS VARIOUS TRANSCATHETER HEART VALVES (THVS), WHILE ADJUSTING FOR ANNULAR DIMENSIONS. DEVICES INCLUDED IN THIS STUDY WERE PORTICO (ABBOTT VASCULAR), SAPIEN 3 ULTRA (EDWARDS LIFESCIENCES), AND EVOLUT PRO+ (MEDTRONIC). THE ARTICLE CONCLUDED THAT COMPARED WITH BALLOON-EXPANDABLE VALVES, SELF-EXPANDING THV MAY OPTIMIZE TRANSVALVULAR HEMODYNAMICS ACROSS ALL ANNULAR DIAMETERS, INDEPENDENT OF THEIR SUPRA-ANNULAR AND INTRA-ANNULAR DESIGN. [THE PRIMARY AND CORRESPONDING AUTHOR WAS IBRAHIM SULTAN, DIVISION OF CARDIAC SURGERY, DEPARTMENT OF CARDIOTHORACIC SURGERY, UNIVERSITY OF PITTSBURGH, PITTSBURGH, PENNSYLVANIA, WITH CORRESPONDING EMAIL: [email protected]].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744282 PORTICO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability| L| R