BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS PASCAL PRECISION

    MDR report key: 24643697 · Received March 19, 2026

    Report

    Report Number
    2015691-2026-11819
    Event Type
    Death
    Date Received
    March 19, 2026
    Date of Event
    November 27, 2024
    Report Date
    March 19, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NKM
    PMA / PMN Number
    P220003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE REPORTED EVENT IS A KNOWN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. SPECIFIC CLINICAL AND PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS TO THE EVENT, OR IF THE EVENT IS RELATED TO AN EDWARDS DEVICE. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THROUGH TVT DATA REGISTRY OF A PATIENT THAT HAD A PASCAL IMPLANTED IN THE MITRAL POSITION AND HAD A CARDIAC ARREST ON THE DAY OF PROCEDURE. THE PATIENT EXPIRED ON POD 1, NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705083 EDWARDS PASCAL PRECISION MITRAL VALVE REPAIR DEVICES NKM EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Death