BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS INFLATION DEVICE

    MDR report key: 23851056 · Received December 19, 2025

    Report

    Report Number
    2015691-2025-10353
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    November 24, 2025
    Report Date
    February 23, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    MAV
    UDI-DI
    00690103210002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EDWARDS INFLATION DEVICE COMMERCIALIZED IN EUROPE BY EDWARDS LIFESCIENCES IS SIMILAR TO THE MARKETED DEVICE IN THE UNITED STATES BY ATRION MEDICAL PRODUCTS, INC. UNDER 510K (K032840). INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    THE EVENT REPORTED IS ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION FOR TRANSCATHETER HEART VALVE PROCEDURES. ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. THE DEVICE WAS NOT RETURNED FOR EVALUATION. DUE TO THE UNAVAILABILITY OF THE COMPLAINT DEVICE, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS. THE INSTRUCTIONS FOR USE (IFU), TRAINING MANUALS AND CURRENT RISK MITIGATIONS HAVE BEEN REVIEWED. NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE REPORTED EVENT FOR LEAKAGE/ LOSS OF VOLUME WAS UNABLE TO BE CONFIRMED DUE TO UNAVAILABILITY OF DEVICE OR IMAGERY. A REVIEW OF DHR AND LOT HISTORY DID NOT REVEAL ANY NON-CONFORMANCES THAT MAY CONTRIBUTE TO THE COMPLAINT EVENT. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. PER THE SUPPLIER (ATRION) INVESTIGATION REPORT, THE REPORTED EVENT IS NOT CONFORMED. PER THE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED TO 'HAND-TIGHTEN THE HUBS SECURELY'. IN THIS CASE, THE INFLATOR DEVICE WAS DISCONNECTED FROM THE THREE-WAY STOPCOCK WHILE INFLATING DE COMMANDER DELIVERY SYSTEM BALLOON, WHICH WAS INDICATING THAT THE STOPCOCK WAS NOT FULLY SECURED OR TIGHTENED LEADING TO A LOSS OF VOLUME. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (NOT FOLLOWING INSTRUCTIONS TO TIGHTEN THE STOPCOCK) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. 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. SINCE NO EDWARDS PRODUCT DEFECTS OR LABELING DEFICIENCIES WERE IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    AS REPORTED BY AN EDWARDS COSTA RICA AFFILIATE, DURING A TRANSFEMORAL TAVR PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE, WHILE DEPLOYING THE VALVE, THE COMMANDER DELIVERY SYSTEM BALLOON APPEARED TO LACK CONTRAST MEDIUM WHICH IMPAIRED VISUALIZATION AND ORIENTATION, RESULTING IN THE VALVE BEING IMPLANTED TOO LOW CAUSING SEVERE PARAVALVULAR LEAK. A SECOND VALVE WAS THEN PLACED; HOWEVER, DURING DEPLOYMENT, THE INFLATOR DISCONNECTED FROM THE THREE-WAY STOPCOCK, PREVENTING FULL INFLATION. THE ISSUE WAS CORRECTED BY SCREWING THE DEFLATOR AGAIN, BUT AS THE VALVE WAS INFLATED, IT WAS POSITIONED TOO HIGH, AND SEVERE CENTRAL VALVULAR LEAK WAS OBSERVED. CONSEQUENTLY, A THIRD VALVE, SIZE 23 MM, WAS IMPLANTED, ACHIEVING CORRECT POSITIONING WITH OPTIMAL RESULTS. THE PHYSICIAN REPORTED THAT THE FIRST TWO VALVES REMAINED OPEN. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251832 EDWARDS INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV EDWARDS LIFESCIENCES 96402 96402R041 00690103210002

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male