BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTICO TRANSCATHETER AORTIC VALVE

    MDR report key: 18595657 · Received January 29, 2024

    Report

    Report Number
    2135147-2024-00387
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    January 1, 2010
    Report Date
    January 29, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 HYPERTENSION, DIABETES MELLITUS, CORONARY ARTERY DISEASE, PRIOR CORONARY ARTERY BYPASS GRAFT, PERIPHERAL ARTERY DISEASE, CEREBROVASCULAR DISEASE, CHRONIC PULMONARY OBSTRUCTIVE DISEASE, CHRONIC KIDNEY DISEASE, PULMONARY HYPERTENSION, AND ATRIAL FIBRILLATION. ONE OF THE COMPLICATIONS REPORTED WAS ARRHYTHMIA. 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 AVAILABLE INFORMATION, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING. LITERATURE ATTACHMENT: ARTICLE TITLE "CLINICAL IMPLICATION OF THE NAPLES PROGNOSTIC SCORE ON TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH SEVERE AORTIC STENOSIS"NA

    Description of Event or Problem · 0

    THE ARTICLE, "CLINICAL IMPLICATION OF THE NAPLES PROGNOSTIC SCORE ON TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH SEVERE AORTIC STENOSIS", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO INVESTIGATE THE PREDICTIVE ROLE OF THE NPS IN DETERMINING MORTALITY IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) UNDER LONG-TERM FOLLOW-UP. DEVICES INCLUDED IN THIS STUDY WAS SAPIEN XT (EDWARDS LIFE SCIENCES), PORTICO (ST. JUDE MEDICAL), COREVALVE EVOLUT R (MEDTRONIC), MYVAL (MERIL LIFE SCIENCES PRIVATE LTD.), AND LOTUS VALVE SYSTEM (BOSTON SCIENTIFIC CORPORATION). THE ARTICLE CONCLUDED THAT THE NAPLES PROGNOSTIC SCORE (NPS).AS A MALNUTRITION AND INFLAMMATION MARKER IN PATIENTS WITH SEVERE AORTIC STENOSIS WHO UNDERWENT TAVR PROVIDES VALUABLE INFORMATION FOR ALL-CAUSE MORTALITY UNDER LONG-TERM FOLLOW-UP. [THE PRIMARY AND CORRESPONDING AUTHOR WAS GÖKHAN DEMIRCI, ISTANBUL MEHMET AKIF ERSOY THORACIC AND CARDIOVASCULAR SURGERY TRAINING AND RESEARCH HOSPITAL, TURGUT ÖZAL BULVARI NO:11, 34303, KUCUKCEKMECE, ISTANBUL, TURKEY, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF STUDY WAS FROM JANUARY 2010 TO DECEMBER 2021. A TOTAL OF 400 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH THE NUMBER OF ABBOTT DEVICES COULD NOT BE CONFIRMED. THE AVERAGE AGE WAS 79.4 YEARS AND THE AVERAGE GENDER WAS FEMALE. COMORBIDITIES INCLUDED HYPERTENSION, DIABETES MELLITUS, CORONARY ARTERY DISEASE, PRIOR CORONARY ARTERY BYPASS GRAFT, PERIPHERAL ARTERY DISEASE, CEREBROVASCULAR DISEASE, CHRONIC PULMONARY OBSTRUCTIVE DISEASE, CHRONIC KIDNEY DISEASE, PULMONARY HYPERTENSION, AND ATRIAL FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839149 PORTICO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention