BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 25299115 · Received May 27, 2026

    Report

    Report Number
    2015691-2026-15543
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 27, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 ESTABLISHMENT NAME: (B)(6). H6 DEVICE CODE: SEPARATION PROBLEM. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    AS REPORTED BY CLINICAL SAFETY, VIA OUR GERMAN AFFILIATES, DURING POST DILATION OF A 26 MM EDWARDS SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION BY TRANSFEMORAL APPROACH, A RUPTURE OF THE DELIVERY DEVICE BALLOON WAS REPORTED, WITH NEED FOR SURGICAL REMOVAL OF A BALLOON FRAGMENT FROM THE GROIN. THE PATIENT WAS DISCHARGED 6 DAYS AFTER THE EVENT. IN THE PERIPROCEDURAL/IN-HOSPITAL ENDPOINTS, VALVE ACADEMIC RESEARCH CONSORTIUM (VARC-3) BLEEDING TYPE 3 WITH TRANSFUSIONS (9 UNITS REPORTED) AND VASCULAR/ACCESS-RELATED COMPLICATIONS (MINOR) WERE REPORTED AND LINKED TO THIS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343838 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750CM26CE NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention