BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 20570250 · Received October 30, 2024

    Report

    Report Number
    2015691-2024-08202
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    October 14, 2024
    Report Date
    December 4, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. INVESTIGATION IS UNDERWAY.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO ENGINEERING EVALUATION FINDINGS. SECTIONS: G3, G6, H2, H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED. THE EVENT REPORTED IS AN 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. THROUGH EXTENSIVE COMPLAINT INVESTIGATIONS, STRUCTURAL VALVE DEGENERATION RELATED TO CALCIFICATION FOR THE SAPIENT XT, S3, AND S3U VALVES HAVE NOT BEEN ASSOCIATED WITH DEVICE MALFUNCTIONS OR MANUFACTURING NONCONFORMANCES. RATHER, THE ROOT CAUSE FOR THESE EVENTS HAVE HISTORICALLY BEEN DUE TO PATIENT FACTORS (AGE, DISEASE STATE, PATIENT CO-MORBIDITIES, AND/OR PHARMACOLOGICAL INTERVENTION). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO UNAVAILABILITY OF RETURNED DEVICE/RELEVANT IMAGERY/RELEVANT MEDICAL RECORDS. THE PROCESS OF CALCIFICATION INVOLVES THE REACTION OF CALCIUM CONTAINING EXTRACELLULAR FLUID WITH MEMBRANE ASSOCIATED PHOSPHORUS, CAUSING CALCIFICATION OF THE CELLS. MANY PATIENT RELATED FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION, AND CONSEQUENTLY, STRUCTURAL DEGENERATION OF THE THV. THESE FACTORS INCLUDE AGE, DISEASE STATE, PATIENT CO MORBIDITIES, AND/OR PHARMACOLOGICAL INTERVENTION, SUCH AS BUT NOT LIMITED TO RENAL FAILURE, HEMODIALYSIS, HYPERCHOLESTEROLEMIA, HYPERLIPIDEMIA, HYPOTHYROIDISM, DIABETES MELLITUS, ETC. IT IS POSSIBLE THAT ONE OR MORE OF THESE FACTORS MAY HAVE BEEN PRESENT; HOWEVER, DUE TO LIMITED INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. 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 FROM THE EDWARDS LIFSCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 2 YEARS POST IMPLANTATION OF AN UNKNOWN SAPIEN VALVE IN A 27 MAGNA SURGICAL VALVE, THE SAPIEN VALVE IS FAILING WITH CALCIFICATION. A REDO SURGERY IS TO BE PERFORMED LIKELY WITH A MECHANICAL VALVE. PATIENT HAS CHEST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020688 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention