BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTICO TRANSCATHETER AORTIC VALVE

    MDR report key: 21960553 · Received May 5, 2025

    Report

    Report Number
    2135147-2025-02361
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    January 1, 2010
    Report Date
    May 29, 2025
    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

    THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE REVIEW: THE IMPACT OF PREPROCEDURAL PULMONARY ARTERY SYSTOLIC PRESSURE ON ACUTE KIDNEY INJURY RELATED TO TRANSCATHETER AORTIC VALVE REPLACEMENT.

    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 PRIOR STROKE, DIABETES MELLITUS, HYPERTENSION, HYPERLIPIDEMIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CORONARY ARTERY DISEASE, HEART FAILURE, AORTIC GRADIENT, SEVERE AORTIC REGURGITATION.. COMPLICATIONS REPORTED INCLUDED SURGICAL INTERVENTION (PACEMAKER), STROKE, CARDIAC TAMPONADE, BLEEDING, ATRIAL FIBRILLATION, ATRIAL FLUTTER, ACUTE KIDNEY INJURY; 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE REVIEW: THE IMPACT OF PREPROCEDURAL PULMONARY ARTERY SYSTOLIC PRESSURE ON ACUTE KIDNEY INJURY RELATED TO TRANSCATHETER AORTIC VALVE REPLACEMENT

    Description of Event or Problem · 0

    THE ARTICLE, "THE IMPACT OF PREPROCEDURAL PULMONARY ARTERY SYSTOLIC PRESSURE ON ACUTE KIDNEY INJURY RELATED TO TRANSCATHETER AORTIC VALVE REPLACEMENT", WAS REVIEWED. THE ARTICLE PRESENTED A SINGLE-CENTER RETROSPECTIVE TO EXPLORE THE PREDICTIVE POTENTIAL OF PULMONARY ARTERY SYSTOLIC PRESSURE (PASP) FOR THE EVOLUTION OF ACUTE KIDNEY INJURY (AKI) FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN AN EFFORT TO MORE RELIABLY ESTABLISH POTENTIAL RISK FACTORS FOR THIS EXPANDING POPULATION. DEVICES INCLUDED IN THE STUDY WERE COREVALVE (MEDTRONIC, MINNEAPOLIS, MINNESOTA, UNITED STATES), PORTICO (ABBOTT STRUCTURAL HEART, ST PAUL, MN, USA) AND ACCURATE NEO AORTIC VALVE (BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA). THE ARTICLE CONCLUDED THAT PASP AT BASELINE WAS FOUND TO BE INDEPENDENTLY ASSOCIATED WITH TAVR-ASSOCIATED AKI EVOLUTION. IN OTHER WORDS, A HIGHER PASP VALUE IN THE PRE-TAVI SETTING MIGHT SERVE AS A POTENTIAL MARKER OF AKI EVOLUTION FOLLOWING TAVI. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MURAT GÖK, DEPARTMENT OF CARDIOLOGY, FACULTY OF MEDICINE, EDIRNE, TRAKYA UNIVERSITY, TURKEY, WITH CORRESPONDING E-MAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2010 TO MAY 2022. A TOTAL OF 90 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH IT WAS NOT SPECIFIED HOW MANY RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 79.2 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED PRIOR STROKE, DIABETES MELLITUS, HYPERTENSION, HYPERLIPIDEMIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CORONARY ARTERY DISEASE, HEART FAILURE, AORTIC GRADIENT, SEVERE AORTIC REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820012 PORTICO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL UNK PORTICO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| S| R