BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTICO TRANSCATHETER AORTIC VALVE

    MDR report key: 23184366 · Received September 30, 2025

    Report

    Report Number
    2135147-2025-05539
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    October 1, 2018
    Report Date
    September 30, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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, CHRONIC LUNG DISEASE, CORONARY ARTERY DISEASE, CEREBRAL VASCULAR DISEASE, CHRONIC KIDNEY DISEASE, PRIOR MYOCARDIAL INFARCTION, ATRIAL FIBRILLATION, PERIPHERAL ARTERY DISEASE, PRIOR PERMANENT PACEMAKER. COMPLICATIONS REPORTED INCLUDED SURGICAL INTERVENTION (PACEMAKER), PARAVALVULAR LEAK, OFF LABEL; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. THE REPORTED IFU DEVIATION/OFF-LABEL USE WAS ASSOCIATED WITH IMPLANTING THE PORTICO VALVE IN A BICUSPID NATIVE AORTIC VALVE. 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. IT WAS REPORTED THAT A PORTICO VALVE WAS IMPLANTED INTO NATIVE BICUSPID AORTIC VALVE ANATOMY. IT SHOULD BE NOTED THAT THE PORTICO VALVE, INSTRUCTIONS FOR USE STATES: "THE SAFETY AND EFFECTIVENESS OF THE PORTICO¿ VALVE AND FLEXNAV¿ DELIVERY SYSTEM HAVE NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: CONGENITAL UNICUSPID OR BICUSPID VALVE, OR ANY LEAFLET CONFIGURATION OTHER THAN TRICUSPID". AS IS THIS FROM A LITERATURE REVIEW, IT IS UNKNOWN IF THE IFU VIOLATION CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT; THEREFORE, A CUSTOMER LETTER WILL NOT BE CREATED B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: LONG-TERM OUTCOMES OF BAV-0 PATIENTS COMPARED WITH BAV-1 AND TAV PATIENTS AFTER TAVR.

    Description of Event or Problem · 0

    THE ARTICLE, "LONG-TERM OUTCOMES OF BAV-0 PATIENTS COMPARED WITH BAV-1 AND TAV PATIENTS AFTER TAVR", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY TO REPORT AND COMPARE THE LONG-TERM CLINICAL OUTCOMES AMONG PATIENTS WITH DIFFERENT ANATOMICAL SUBTYPES OF AORTIC VALVE STENOSIS (AS) UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). DEVICES INCLUDED IN THE STUDY WAS SAPIEN 3/XT, COREVALVE/EVOLUT R/PRO, VENUSA/A-PLUS, SYM TF/ACURATENEO/ACURATENEO2, PORTICO, LOTUS, TAURUSONE, VITAFLOW, DIRECTFLOW, AND CENTERA. THE ARTICLE CONCLUDED THAT AMONG PATIENTS WITH SEVERE AS UNDERGOING TAVR, BICUSPID AORTIC VALVES (BAV) OF TYPE 0 (BAV-0) WAS ASSOCIATED WITH A BETTER LONG-TERM PROGNOSIS COMPARED WITH TAV AND BAV OF TYPO 1 (BAV-1). [THE PRIMARY AND CORRESPONDING AUTHOR WAS MAO CHEN, CARDIAC STRUCTURE AND FUNCTION RESEARCH KEY LABORATORY OF SICHUAN PROVINCE, WEST CHINA HOSPITAL, SICHUAN UNIVERSITY, #37 GUOXUE LANE, CHENGDU 610041, PR CHINA, WITH CORRESPONDING E-MAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM OCTOBER 2018 TO OCTOBER 2023. A TOTAL OF 2553 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 437 (17.1%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 79.9 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HYPERTENSION, DIABETES, CHRONIC LUNG DISEASE, CORONARY ARTERY DISEASE, CEREBRAL VASCULAR DISEASE, CHRONIC KIDNEY DISEASE, PRIOR MYOCARDIAL INFARCTION, ATRIAL FIBRILLATION, PERIPHERAL ARTERY DISEASE, PRIOR PERMANENT PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105310 PORTICO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL UNK PORTICO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention