BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 20740362 · Received November 20, 2024

    Report

    Report Number
    2015691-2024-08775
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    October 30, 2024
    Report Date
    December 13, 2024
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    UDI-DI
    00690103194364
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS REPORTED BY EDWARDS LIFESCIENCES UNDER MANUFACTURER REPORT # 201569-2024-08775. ADDITIONAL INFORMATION WAS OBTAINED THAT INDICATES THIS EVENT WAS PREVIOUSLY REPORTED UNDER MANUFACTURER REPORT # 2015691-2024-08704. AS SUCH, THIS MDR WAS REPORTED IN ERROR WITH A CORRECTED SUPPLEMENTAL REPORT BEING SUBMITTED. INVESTIGATION OF THIS EVENT WILL CONTINUE TO BE UPDATED AND REPORTED THROUGH MANUFACTURER REPORT # 2015691-2024-08704.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 4 YEARS POST TRANSFEMORAL TAVR PROCEDURE WITH A 29 MM SAPIEN 3 VALVE, THE VALVE WAS FAILING DUE TO STENOSIS. A 26 MM SAPIEN 3 ULTRA RESILIA VALVE WAS SUCCESSFULLY IMPLANTED INTO THE FAILING VALVE. THE PHYSICIAN DECIDED NOT TO POST DILATE AND A 10MM ECHO GRADIENT WAS RECORDED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2458686 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9600TFX29A 00690103194364

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention