BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA RESILIA VALVE

    MDR report key: 24223435 · Received January 30, 2026

    Report

    Report Number
    2015691-2026-10690
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    January 5, 2026
    Report Date
    March 11, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103215816
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION FROM A PRODUCT INVESTIGATION. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN UPDATED: B.4, G.3, G.6, H.2 AND H.6. THE EVENT REPORTED IS ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION FOR TRANSCATHETER HEART VALVE PROCEDURES. A PREVIOUS INVESTIGATION INTO THIS TYPE OF EVENT IS CAPTURED IN AN EDWARDS LIFESCIENCES TECHNICAL SUMMARY AND APPLIES TO THIS COMPLAINT. 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. PER THE TECHNICAL SUMMARY, THE IFU, CURRENT RISK MITIGATIONS INCLUDE DESIGN AND MANUFACTURING CONTROLS, AND TRAINING MANUALS HAVE BEEN REVIEWED, NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. IN THIS CASE, INCREASED GRADIENT WAS EMPIRICALLY CONFIRMED BASED ON INFORMATION RECEIVED TO DATE. IT IS POSSIBLE THAT ONE OR MORE PATIENT/PROCEDURAL FACTORS IDENTIFIED IN THE TECHNICAL SUMMARY MAY HAVE BEEN PRESENT AND CONTRIBUTED TO THE COMPLAINT EVENT. HOWEVER, DUE TO INSUFFICIENT INFORMATION, A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED. 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 A FIELD CLINICAL SPECIALIST, THE PATIENT HAS A 27MM MAGNA IMPLANTED 2016, THEN 26MM S3UR IMPLANTED 2023 IN THE AORTIC POSITION. DURING A TPVR PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN A PRE-EXISTING EDWARDS SURGICAL VALVE, FOLLOWING TPVR IMPLANT, THE PATIENT WENT INTO FLASH PULMONARY EDEMA AND CARDIAC ARREST WITH RESUSCITATION AND PLACED ON ECMO. APPROXIMATELY 6 DAYS POST TPVR THE PATIENT WAS EVALUATED AND DETERMINED TO HAVE STENOSIS AND INCREASED MEAN GRADIENT (>50MMHG) OF THE 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION THAT WAS IMPLANTED IN 2023. THE TEAM THEN ELECTED TO PROCEED WITH A THV-IN-THV-IN-SAV. DURING INITIAL VALVE DEPLOYMENT THE VALVE EMBOLIZED INTO THE AORTA AND FELT RELATED TO A PVC (PREMATURE VENTRICULAR CONTRACTION). THE FIRST VALVE WAS PULLED INTO THE DESCENDING AORTA AND THE SECOND VALVE WAS ADVANCED AND DEPLOYED WITHOUT INCIDENT. PATIENT WAS TRANSFERRED IN GUARDED CONDITION ON ECMO TO THE ICU. THERE WAS NO ALLEGATION ANY EDWARDS DEVICE WAS DEFICIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281849 EDWARDS SAPIEN 3 ULTRA RESILIA VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9755RSL26A 00690103215816

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention