BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE / P140031

    MDR report key: 17652153 · Received August 30, 2023

    Report

    Report Number
    2015691-2023-15577
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    August 9, 2023
    Report Date
    August 30, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103194357
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (IFU), STRUCTURAL VALVE DETERIORATION (WEAR, FRACTURE, CALCIFICATION, LEAFLET TEAR/TEARING FROM THE STENT POSTS, LEAFLET RETRACTION, SUTURE LINE DISRUPTION OF COMPONENTS OF A PROSTHETIC VALVE, THICKENING, STENOSIS), IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PER A TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, CALCIFIC DEGENERATION IS A COMMON CAUSE OF BIOPROSTHETIC HEART VALVE FAILURES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS' TISSUE VALVES DUE TO SUBSEQUENT ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESIS FROM CALCIFYING. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. DUE TO A LIMITED AMOUNT OF INFORMATION RECEIVED, IT IS UNKNOWN WHAT COULD 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. 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. H3 OTHER TEXT : REMAINS IMPLANTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), 7 YEAR, 2 MONTHS, AND 29 DAYS POST-IMPLANT OF A 26 MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE VALVE REQUIRED INTERVENTION FOR NORMAL WEAR (DEGENERATION WITH STENOSIS AND CALCIUM) AND A VALVE IN VALVE WAS PERFORMED. THE PATIENT WAS EXPERIENCING WORSENING DYSPNEA ON EXERTION. PER A MEDICAL RECORD REVIEW, THE BIOPROSTHETIC AORTIC VALVE IS MALFUNCTIONING AS THE LEAFLETS ARE SEVERELY CALCIFIED. THE LEFT BIOPROSTHETIC CORONARY CUSP WITH SEVERE RESTRICTION OF THE OTHER 2 LEAFLETS WITH MODERATE REGURGITATION DIRECTED ECCENTRICALLY IN THE LVOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680321 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE / P140031 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX26A 00690103194357

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention