BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS INFLATION DEVICE

    MDR report key: 23294253 · Received October 15, 2025

    Report

    Report Number
    2015691-2025-08341
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 22, 2025
    Report Date
    December 19, 2025
    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

    UPDATE TO D9 AND H3. CORRECTION TO H6; COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSION. THE EVENT REPORTED IS ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION FOR TRANSCATHETER HEART VALVE PROCEDURES. ADDITIONAL ASSESSMENT OF THE FAILURE MODE(S) IS NOT REQUIRED AT THIS TIME. THE DEVICE WAS RETURNED FOR EXAMINATION AND A VISUAL INSPECTION FOUND NO VISUAL DAMAGE OBSERVED ON THE LOCKING MECHANISM. WAS ABLE TO LOCK AND UNLOCK THE INFLATION DEVICE WITHOUT RESISTANCE OR ABNORMALITIES. FUNCTIONAL TESTING FOUND THAT THE LOCKING MECHANISM WAS ABLE TO BE LOCKED AND UNLOCKED WITHOUT ANY RESISTANCE. THE INFLATION SYRINGE WAS ABLE TO BE FILLED WITH SALINE SOLUTIONS AND EMPTIED WITH NO ABNORMALITIES. NO ABNORMALITIES WHILE SCREWING THE PLUNGER OF THE INFLATION DEVICE AFTER BEING LOCKED. THE REPORTED EVENT WAS NOT CONFIRMED THROUGH RETURNED PRODUCT EVALUATION AS THE ALLEGED PHYSICAL DEFECT IS NOT PRESENT ON THE RETURNED DEVICE. AS REPORTED, "WHEN TRYING TO DEFLATE THE DELIVERY SYSTEM BALLOON IT WAS NOTED DIFFICULTY TO UNLOCK THE INFLATION DEVICE". DURING EVALUATION OF THE RETURNED DEVICE, THE INFLATION SYRINGE AND LOCKING MECHANISM WERE VISUALLY EXAMINED THE SYRINGE WAS ABLE TO BE LOCKED AND UNLOCKED WITH NO ABNORMALITIES OBSERVED. AS THERE IS NO EVIDENCE OF PRODUCT NON-CONFORMANCE OR DEVICE MALFUNCTION, NO FURTHER ENGINEERING EVALUATION IS REQUIRED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. 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).

    Description of Event or Problem · 0

    AS REPORTED BY EDWARDS AFFILIATES IN AUSTRALIA, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 26MM SAPIEN 3 ULTRA VALVE VIA RIGHT TRANSFEMORAL ARTERY ACCESS, DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO DEFLATE THE DELIVERY SYSTEM BALLOON FOLLOWING SUCCESSFUL VALVE DEPLOYMENT. SPECIFICALLY, THE INFLATION DEVICE WAS INITIALLY DIFFICULT TO UNLOCK; HOWEVER, IT WAS EVENTUALLY RELEASED, ALLOWING FOR SUCCESSFUL BALLOON DEFLATION AND REMOVAL. THE PATIENT DID NOT EXPERIENCE ANY INJURY AND WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535934 EDWARDS INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV EDWARDS LIFESCIENCES 96402 96402R03 00690103210002

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male