BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA

    MDR report key: 23306121 · Received October 15, 2025

    Report

    Report Number
    2015691-2025-08378
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    November 21, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103199734
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO CORRECTION AND ENGINEERING EVALUATION FINDINGS. SECTIONS B4, G3, G6, H2, H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS, AND H11 HAVE BEEN UPDATED. CORRECTED H6 COMPONENT CODE & DEVICE CODE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE EVENTS REPORTED ARE 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(S) IS NOT REQUIRED AT THIS TIME. IMAGERY PROVIDED BY THE SITE REVEALED CLEAR AORTIC VALVE REGURGITATION FOLLOWING THE INITIAL VALVE IMPLANTATION, WITH EVIDENCE OF IMPROPER LEAFLET COAPTATION CONTRIBUTING TO THE DYSFUNCTION. A SUBSEQUENT VALVE-IN-VALVE PROCEDURE WAS SUCCESSFULLY PERFORMED, RESULTING IN PROPER VALVE FUNCTION WITH NO SIGNIFICANT REGURGITATION OBSERVED. THROUGH EXTENSIVE COMPLAINT INVESTIGATIONS, CENTRAL REGURGITATION EVENTS POST-DEPLOYMENT WITH OR WITHOUT REPORT RELATED TO LEAFLET MOBILITY FOR THE S3, S3U, AND S3UR VALVES HAVE NOT BEEN ASSOCIATED WITH DEVICE MALFUNCTIONS OR MANUFACTURING NONCONFORMANCES. RATHER, THE ROOT CAUSE FOR THESE EVENTS HAVE HISTORICALLY BEEN DUE TO PATIENT AND/OR PROCEDURAL FACTORS (MALPOSITION, SLOW RECOVERY OF BLOOD FLOW, LEAFLET IMPINGMENT DUE TO CALCIFICATION OR GUIDEWIRE, OVER-INFLATION, POST-DILATION, AND/OR UNDER-EXPANSION). THE COMPLAINT FOR DEPLOYED VALVE EXHIBITS CENTRAL REGURGITATION AND LEAFLET MOTION RESTRICTED-IN PATIENT WERE CONFIRMED BASED ON EVALUATION OF THE PROVIDED IMAGERY. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (UNDER-EXPANSION) LIKELY CONTRIBUTED TO THE EVENT AS PROVIDED INFORMATION INDICATED THAT THE VALVE WAS DEPLOYED USING LESS THAN THE PRESCRIBED VOLUME (-1.5CC DURING INITIAL DEPLOYMENT AND -1CC DURING POST DILATION). DEPLOYING THE VALVE USING LESS THAN THE PRESCRIBED VOLUME MAY RESULT IN INABILITY FOR THE VALVE LEAFLETS TO PROPERLY FUNCTION. THE DECREASE IN VALVE DIAMETER DUE TO LACK OF DEPLOYMENT VOLUME MAY RESULT IN A GAP BETWEEN THE VALVE LEAFLETS PREVENTING THE VALVE FROM FULLY CLOSING. UNDER EXPANDING THE VALVE MAY ALSO PREVENT THE VALVE LEAFLETS FROM FULLY OPENING AND ALLOWING PROPER EJECTION FRACTION. LASTLY, SHAPE OF EXISTING LANDING ZONE (VALVE/RING, NON-CIRCULAR ANNULUS, BICUSPID PATIENT, ETC.) MAY RESULT IN UNDER DEPLOYMENT OF THE VALVE. THE VALVE MUST BE FULLY DEPLOYED FOR PROPER FUNCTION. 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

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    PER REPORT RECEIVED FROM SOUTH KOREA, IT WAS A CASE OF AN IMPLANT OF A 23MM SAPIEN 3 ULTRA VALVE IN AORTIC POSITION. AFTER VALVE DEPLOYMENT USING -1.5CC, ECHO SHOWED SEVERE CENTRAL REGURGITATION WITH ONE LEAFLET NOT WORKING PROPERLY. THE WIRE WAS RELOCATED BUT THE SEVERE REGURGITATION PERSISTED. IT WAS THEN ATTEMPTED TO POST-DILATE THE VALVE ADDING +0.5CC (TOTAL OF -1CC), BUT THE SEVERE REGURGITATION REMAINED. THE VALVE DID NOT LOOK UNDER-EXPANDED. A NEW VALVE WAS IMPLANTED AS A VALVE-IN-VALVE TO TREAT THE SEVERE REGURGITATION. THE PATIENT WAS NOTED TO BE WELL RECOVERED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2773092 EDWARDS SAPIEN 3 ULTRA AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750TFX23 NA 00690103199734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention