BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPIEN M3 VALVE, STAGE P

    MDR report key: 20131607 · Received September 3, 2024

    Report

    Report Number
    2015691-2024-06829
    Event Type
    Death
    Date Received
    September 3, 2024
    Date of Event
    July 19, 2024
    Report Date
    October 14, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    UDI-DI
    00690103214291
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE 29MM M3 VALVE WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. WITHOUT THE DEVICE RETURNED FOR EVALUATION, VISUAL INSPECTION, FUNCTIONAL TESTING, AND DIMENSIONAL ANALYSIS WERE UNABLE TO BE COMPLETED. THE FOLLOWING INSTRUCTIONS FOR USE (IFU) WERE REVIEWED: SAPIEN M3 SYSTEM. BASED ON THIS REVIEW, NO IFU TRAINING DEFICIENCIES WERE IDENTIFIED. 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 THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. THE REPORTED EVENT OF CENTRAL LEAK AND STENOSIS WERE CONFIRMED EMPIRICALLY FROM THE MEDICAL RECORDS. A REVIEW OF THE COMPLAINT HISTORY DID NOT PROVIDE ANY INDICATION THAT MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE IFU REVEALED NO DEFICIENCIES. DURING THE MANUFACTURING PROCESS, ALL SAPIEN M3 VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR PROPER COAPTATION UNDER PHYSIOLOGICAL BACKPRESSURE CONDITIONS PRIOR TO RELEASE FOR DISTRIBUTION. IN ADDITION, DURING VALVE ASSEMBLY, LEAFLET TISSUE IS SUBMITTED FOR THICKNESS MEASUREMENTS. THEREFORE, IT IS HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION CONTRIBUTED TO THE EVENT. PER THE MEDICAL RECORD, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS, AND TREATMENT WAS STARTED WITH COUMADIN. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) FROM APPROXIMATELY A MONTH LATER SHOWED THAT THE THROMBUS HAD BEEN RESOLVED. THE ONE-YEAR TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED PATIENT'S VALVE IS EXHIBITING MILD VALVULAR REGURGITATION WITH MILD TO MODERATE STENOSIS WITH AN EOA OF 0.93CM2. INADEQUATE LEAFLET COAPTATION CAN RESULT IN CENTRAL REGURGITATION. THE PATIENT WAS DIAGNOSED WITH THROMBOSIS, WHICH WAS SHOWN TO BE RESOLVED APPROXIMATELY A MONTH AFTER TREATMENT. HOWEVER, IT IS POSSIBLE THAT THROMBOSIS MAY HAVE CAUSED IMPROPER COAPTATION OF THE LEAFLETS LEADING TO CENTRAL REGURGITATION. VALVE STENOSIS CAN RESULT FROM A NUMBER OF FACTORS, INCLUDING PANNUS, CALCIFICATION, SUPPORT STRUCTURE DEFORMATION (OUT-OF-ROUND CONFIGURATION), TRAUMA (CARDIA-PULMONARY RESUSCITATION, BLUNT CHEST TRAUMA), ENDOCARDITIS, PROSTHETIC VALVE THROMBOSIS, AND NATIVE LEAFLET PROLAPSE IMPEDING PROSTHETIC LEAFLET MOTION. IN THIS CASE, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS, WHICH IS LIKELY IMPEDING LEAFLET MOTION. AS SUCH, AVAILABLE INFORMATION SUGGESTS PATIENT FACTORS (THROMBOSIS) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 BY THE ENCIRCLE CLINICAL TRIAL, THE ONE-YEAR AND 1-MONTH TRANSTHORACIC ECHOCARDIOGRAM (TTE)) NOTES WORSENING MILD TO MODERATE REGURGITATION OF THE MITRAL VALVE WITH MULTIPLE JETS. PER MEDICAL RECORD REVIEW, MILD TO MODERATE STENOSIS WAS NOTED AND THE MITRAL VALVE (MV) PEAK/MEAN GRADIENT WAS 15/7MMHG. THE AORTIC VALVE AREA (EOA) WAS 0.93 CM2. THE PATIENT'S PROGNOSIS WAS POOR AND WOULD TAKE YEARS FOR SUBOPTIMAL RECOVERY OF ANY SMALL FUNCTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO HOSPICE CARE. ALTHOUGH THE PATIENT WAS NOT TREATED IF THE PATIENT'S CONDITION WAS SUITABLE FOR SURGERY, INTERVENTION WOULD BE THE NEXT STEP FOR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804728 SAPIEN M3 VALVE, STAGE P PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9880TFX29MCLUS 00690103214291

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Death