BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN M3 DOCK STEERABLE CATHETER

    MDR report key: 24225667 · Received January 30, 2026

    Report

    Report Number
    2015691-2026-10694
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    January 14, 2026
    Report Date
    March 9, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    UDI-DI
    00690103214314
    PMA / PMN Number
    P250019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ONGOING AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT FOR DEVICE AND/OR GUIDEWIRE NEGATIVELY INTERACTS WITH CONDUCTION SYSTEM WAS UNABLE TO BE CONFIRMED. THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY. PER THE INTERNAL IMAGE EVALUATION, THERE SEEMED TO BE INTERACTION BETWEEN THE DDS/DOCK AND THE JUNCTION BETWEEN THE ANTERIOR MEDIAL LEFT ATRIUM AND THE MITRAL ANNULUS. HOWEVER, IT WAS NOTED THAT THE EKG APPEARED STABLE BOTH AT BASELINE AND IN ALL THE IMAGES PROVIDED, WITH THE FINAL EKG UNAVAILABLE AS IT APPEARED TO BE DISCONNECTED. AS SUCH, THE ALLEGATION OF CONDUCTION ABNORMALITIES WAS UNABLE TO BE CONFIRMED. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO NONCONFORMANCES RELATED TO THE COMPLAINT EVENT WERE IDENTIFIED. SINCE THERE ARE NO CONFIRMED PRODUCT OR LABELING/IFU/TRAINING MATERIAL NON-CONFORMANCES AFFECTING DISTRIBUTED PRODUCT AND NO OTHER TRIGGERS HAVE BEEN MET, NO PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED A REPORT OF A SAPIEN M3 PROCEDURE IN MITRAL POSITION WHERE WAS SOME TYPE OF AV BLOCK THAT OCCURRED DURING THE 1/4 TURN. THE PATIENT LEFT THE LAB WITH A TEMPORARY PACER. THE PATIENT RECEIVED A PERMANENT PACEMAKER ON POD 2 AND THEN WAS DISCHARGED ON POD 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289060 SAPIEN M3 DOCK STEERABLE CATHETER PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9880DDSCLUS 00690103214314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention