BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE

    MDR report key: 23312170 · Received October 16, 2025

    Report

    Report Number
    2015691-2025-08393
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 29, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103215823
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED TO RETRACT THE PREVIOUSLY REPORTED EVENT. SECTIONS B4, G3, G6, H2, H6: HEALTH EFFECT - CLINICAL CODE AND H11 HAVE BEEN UPDATED. ACCORDING TO THE PROVIDED MEDICAL RECORDS, A MOBILE VEGETATION WAS SEEN ON THE NATIVE MITRAL VALVE, ALONG WITH MILD MITRAL REGURGITATION AND AN AORTIC VALVE MEAN GRADIENT OF 9MMHG, AS DETECTED PER ECHOCARDIOGRAPHY PERFORMED 6 DAYS PRIOR TO VALVE EXPLANT. NO AORTIC REGURGITATION OR PARAVALVULAR LEAK WERE DETECTED. THE PATHOLOGY REPORT REVEALED THE PATIENT CONTRACTED GROUP B STREPTOCOCCAL BACTEREMIA AT AN OUTSIDE INSTITUTION (AORTIC VEGETATION, ENDOCARDITIS OF MITRAL VALVE). AT THE TIME OF THIS REPORT, THE INFORMATION AVAILABLE DOES NOT SUGGEST THE EDWARDS SAPIEN 3 ULTRA RESILIA VALVE MALFUNCTIONED, OR THAT THE USE OR MISS-USE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE VALVE EXPLANT. THERE WAS NO ALLEGATION OF DEFICIENCIES RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, LABELING EFFECTIVENESS, OR PERFORMANCE OF THIS DEVICE; THEREFORE THE EXPLANT EVENT IS NO LONGER CONSIDERED FDA REPORTABLE.

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (IFU), NON-EMERGENT REOPERATION, EMERGENCY CARDIAC SURGERY, REOPERATION, DEVICE MIGRATION OR MALPOSITION REQUIRING INTERVENTION AND DEVICE EXPLANT ARE LISTED AS POTENTIAL RISKS ASSOCIATED WITH THE DEVICE AND TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE. THE IFU CAUTIONS THAT LONG-TERM DURABILITY HAS NOT BEEN ESTABLISHED FOR THE VALVE. REGULAR MEDICAL FOLLOW-UP IS ADVISED TO EVALUATE VALVE PERFORMANCE. ACCELERATED DETERIORATION OF THE VALVE DUE TO CALCIFIC DEGENERATION MAY OCCUR IN CHILDREN, ADOLESCENTS, OR YOUNG ADULTS AND IN PATIENTS WITH AN ALTERED CALCIUM METABOLISM. VALVE RECIPIENTS SHOULD BE MAINTAINED ON ANTICOAGULANT/ANTIPLATELET THERAPY, EXCEPT WHEN CONTRAINDICATED, AS DETERMINED BY THEIR PHYSICIAN. THIS DEVICE HAS NOT BEEN TESTED FOR USE WITHOUT ANTICOAGULATION. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. VALVE REINTERVENTION MAY BE DUE TO VALVE DYSFUNCTION (E.G., SEVERE, OR CLINICALLY SIGNIFICANT PARAVALVULAR LEAK, CENTRAL LEAK, SIGNIFICANT MALPOSITION, EARLY/LATE ENDOCARDITIS, THROMBOSIS, STRUCTURAL VALVE DETERIORATION OR DEGENERATION) AND/OR OTHER REASONS UNRELATED TO THE EDWARDS DEVICES (E.G., TREATMENT OF OTHER PATIENT COMORBIDITIES). DURING THE MANUFACTURING PROCESS, ALL SAPIEN VALVES (ALL MODELS) ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED UNDER PHYSIOLOGICAL BACKPRESSURE CONDITIONS PRIOR TO RELEASE FOR DISTRIBUTION. THEREFORE, IT IS HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION CONTRIBUTED TO THE EVENT. IN THIS CASE, DESPITE MULTIPLE INVESTIGATIONAL ATTEMPTS, IT WAS NOT POSSIBLE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS EVENT. DUE TO LIMITED INFORMATION, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. AT THE TIME OF THIS REPORT, THE INFORMATION AVAILABLE DOES NOT REASONABLY SUGGEST THERE WAS A MALFUNCTION OF THE EDWARDS DEVICE OR THAT THE USE OR MISS-USE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THERE IS NO ALLEGATION OF DEFICIENCIES RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, LABELING EFFECTIVENESS, OR PERFORMANCE OF THIS EDWARD DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE INFORMATION WILL BE REVIEWED, AND THE FILE UPDATED ACCORDINGLY. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO ADMINISTRATIVE REVIEW. SECTIONS B4, G3, G6, H2 AND H11 HAVE BEEN UPDATED. ACCORDING TO THE PROVIDED MEDICAL RECORDS, A MOBILE VEGETATION WAS SEEN ON THE NATIVE MITRAL VALVE, ALONG WITH MILD MITRAL REGURGITATION, A LARGE VEGETATION ON THE 29MM SAPIEN 3 ULTRA RESILIA VALVE WITH AN AORTIC VALVE MEAN GRADIENT OF 9MMHG, AS DETECTED PER ECHOCARDIOGRAPHY PERFORMED 6 DAYS PRIOR TO VALVE EXPLANT. NO AORTIC REGURGITATION OR PARAVALVULAR LEAK WERE DETECTED. THE PATHOLOGY REPORT REVEALED THE PATIENT CONTRACTED GROUP B STREPTOCOCCAL BACTEREMIA AT AN OUTSIDE INSTITUTION (AORTIC VEGETATION, ENDOCARDITIS OF MITRAL VALVE). AT THE TIME OF THIS REPORT, THE INFORMATION AVAILABLE DOES NOT SUGGEST THE EDWARDS SAPIEN 3 ULTRA RESILIA VALVE MALFUNCTIONED, OR THAT THE USE OR MISS-USE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE VALVE EXPLANT. THERE WAS NO ALLEGATION OF DEFICIENCIES RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, LABELING EFFECTIVENESS, OR PERFORMANCE OF THIS DEVICE; THEREFORE THE EXPLANT EVENT IS NO LONGER CONSIDERED FDA REPORTABLE.

    Description of Event or Problem · 0

    AS REPORTED THROUGH EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY (IPR), APPROXIMATELY 5 MONTHS POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE NATIVE AORTIC POSITION, THE VALVE WAS EXPLANTED DUE TO AN UNKNOWN CAUSE. A 25MM SURGICAL VALVE WAS IMPLANTED IN THE AORTIC POSITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252850 EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9755RSL29A 00690103215823

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention