BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS LIFESCIENCES SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 23578315 · Received November 18, 2025

    Report

    Report Number
    2015691-2025-09349
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 17, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    07612989037491
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURY INCLUDING HEMATOMA, PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, ATRIUM, SEPTUM, MYOCARDIUM OR VALVULAR STRUCTURES THAT MAY REQUIRE INTERVENTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND MAY REQUIRE INTERVENTION. ACCORDING TO THE DEVICE TRAINING MANUALS, RISK FACTORS FOR AORTIC DISSECTION, CARDIAC/AORTIC HEMATOMA, OR ANNULAR RUPTURE DURING THE TVR PROCEDURE INCLUDE SIGNIFICANT VALVE OVER SIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION, AND NARROW CALCIFIED SINOTUBULAR JUNCTION. IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. THE SAPIEN TRANSCATHETER HEART VALVE (ALL MODELS) RELIES CALCIUM TO SECURELY ANCHOR IN THE LANDING ZONE. DESPITE THIS BENEFICIAL ASPECT OF CALCIUM, BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE, WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES, THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE, AND PROCEDURAL SUCCESS. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST PATIENT FACTORS (VERY CALCIFIED ANNULUS) MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. 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. 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, IT WAS A 29MM SAPIEN 3 TRANSCATHETER HEART VALVE IMPLANT PROCEDURE IN AORTIC POSITION USING RIGHT CAROTID APPROACH IN A PATIENT WITH BICUSPID VALVE TYPE 1 - LR. DURING PROCEDURE, ANNULAR RUPTURE OCCURRED AND PATIENT WAS CONVERTED TO OPEN SURGERY. PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768038 EDWARDS LIFESCIENCES SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX29 07612989037491

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention