BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 23457135 · Received November 3, 2025

    Report

    Report Number
    2015691-2025-09020
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 3, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVES ARE: P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; P140031 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM; P140031 EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE SYSTEM. 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.

    Description of Event or Problem · 0

    AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A TRANSCATHER VALVE IN TRANSCATHETER VALVE WAS PERFORMED. THE VALVE MODELS, IMPLANT DATES, CAUSE OF VALVE IN VALVE, AND PATIENT SYMPTOMS BEFORE VALVE IN VALVE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077445 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention