BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER VALVE

    MDR report key: 17887373 · Received October 6, 2023

    Report

    Report Number
    2015691-2023-16606
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    September 21, 2023
    Report Date
    November 13, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR ADDITIONAL INFORMATION FROM A PRODUCT INVESTIGATION. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN UPDATED: B4, G3, G6, H2, AND H6. THE COMPLAINT FOR LEAFLET THICKENED/HALT WAS UNABLE TO BE CONFIRMED AS NO RELEVANT IMAGERY/MEDICAL REPORT WAS PROVIDED. A REVIEW OF THE IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. AS DEVICE WAS NOT RETURNED, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL, FUNCTIONAL, OR DIMENSIONAL ANALYSIS. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. PER REVIEW, NO EVIDENCE OF PRODUCT NON-CONFORMANCES OR LABELING/IFU INADEQUACIES WERE IDENTIFIED IN THE EVALUATION. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 3 VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR PROPER COAPTATION 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. HYPOATTENUATED LEAFLET THICKENING (HALT) MAY BE CAUSED BY SEVERAL PATIENT-RELATED FACTORS INCLUDING EARLY VALVE DETERIORATION (SVD) (E.G. STENOSIS/CALCIFICATION), NON-STRUCTURAL DYSFUNCTION (E.G. PANNUS), OR THROMBOSIS. AS REPORTED, ''HYPOATTENUATED LEAFLET THICKENING (HALT) WAS CONFIRMED APPROXIMATELY 6 MONTHS LATER SINCE THE TAVR PROCEDURE (APPROACH UNKNOWN). THE PEAK FLOW VELOCITY (PFV) WAS ACCELERATING. CT REVEALED THE HALT. THE PATIENT WAS HOSPITALIZED AND ANTICOAGULANT WAS ADMINISTERED.'' IN THIS CASE, THE PATIENT WAS PRESCRIBED AN ANTICOAGULANT MEDICATION, WHICH SUSPECTED THAT PATIENT WAS POTENTIALLY TO HAVE THROMBOSIS RESULTING IN LEAFLET THICKENING/HALT. VALVE THROMBOSIS IS THE FORMATION OF SIGNIFICANT BLOOD CLOTS FORMING ON THE VALVE. THESE CLOTS COULD SIGNIFICANTLY IMPACT THE FUNCTIONALITY OF THE VALVE RESULTING IN LEAFLET THICKENING/HALT. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (THROMBOSIS) MAY HAVE CONTRIBUTED TO THE COMPLAINT 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. NO CORRECTIVE NOR PREVENTATIVE ACTIONS (PRA) ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. H3 OTHER TEXT : THE VALVE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    AS REPORTED BY OUR EDWARDS LIFESCIENCES JAPANESE AFFILIATE, HYPOATTENUATED LEAFLET THICKENING (HALT) WAS CONFIRMED APPROXIMATELY 6 MONTHS POST TAVR PROCEDURE WITH A 23MM SAPIEN 3 VALVE. THE PEAK FLOW VELOCITY (PFV) WAS ACCELERATING. A CT REVEALED THE HALT. THE PATIENT WAS HOSPITALIZED AND ANTICOAGULANT WAS ADMINISTERED. PER THE MEDICAL OPINION, THE EVENT WAS DETERMINED AS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307804 EDWARDS SAPIEN 3 TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX23J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention