BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 13270068 · Received January 17, 2022

    Report

    Report Number
    2015691-2022-03434
    Event Type
    Injury
    Date Received
    January 17, 2022
    Date of Event
    December 28, 2021
    Report Date
    February 14, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL ONGOING. THE TYPE OF THV VALVE IS UNKNOWN; HOWEVER, THE POSSIBLE PMA NUMBERS P140031 ASSOCIATED WITH AN EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO DEVICE INFORMATION RECEIVED. SECTION D1, D4, D6, E1, E3 , H4 AND HEALTH EFFECT - CLINICAL CODE HAS BEEN UPDATED.

    Description of Event or Problem · 0

    AS REPORTED, POST IMPLANTATION OF A SAPIEN 3 VALVE IN THE AORTIC POSITION THE PATIENT WAS PRESENTED WITH REGURGITATION AND LEAFLET THROMBOSIS. THE PATIENT WAS TREATED WITH A VALVE-IN-VALVE WITH A 26MM SAPIEN 3 ULTRA VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163173 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention