BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    PORTICO TRANSCATHETER AORTIC VALVE

    MDR report key: 17401352 · Received July 26, 2023

    Report

    Report Number
    2135147-2023-03229
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    November 16, 2021
    Report Date
    July 26, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    STS/ACC TVT REGISTRY REPORTS 45 PATIENTS WITH PERMANENT PACEMAKER. NO DEVICES WERE RETURNED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS NO ADDITIONAL 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 QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING. D6A. THE EARLIEST IMPLANT DATE WAS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH STS/ACC TVT REGISTRY DATA THAT PORTICO VALVE DEVICES MAY BE RELATED TO 45 PATIENTS WITH PERMANENT PACEMAKER ADVERSE EVENTS WHICH ARE CONSIDERED SERIOUS INJURY. THE RELATIONSHIP OF THE ADVERSE EVENTS TO THE PORTICO VALVE DEVICES COULD NOT BE DETERMINED BASED ON THE LIMITED DATA RECEIVED FROM THE REGISTRY. STS/ACC TVT REGISTRY DATA IS REPORTED AS A SUMMARY PER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER -GEN2201027 . THE DATA RECEIVED INDICATED THAT THE PROCEDURE DATE RANGE WAS BETWEEN 16 NOVEMBER 2021 ¿ 28 DECEMBER 2022 PATIENTS¿ MEAN AGE IS 82 YEARS, RANGING FROM YEARS. 22% OF THE PATIENTS WERE MALE, 78% OF THE PATIENTS WERE FEMALE. AVERAGE TIME TO EVENT IN DAYS WAS 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630650 PORTICO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Other