BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 6233481 · Received January 9, 2017

    Report

    Report Number
    2015691-2017-00043
    Event Type
    Injury
    Date Received
    January 9, 2017
    Date of Event
    November 16, 2016
    Report Date
    December 16, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS ONGOING.

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE THV PROCEDURE IN THE PULMONIC POSITION. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, LEAFLET THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. REGURGITATION MAY ALSO DEVELOP PROGRESSIVELY IF HOST FIBROTIC TISSUE, OR PANNUS, GROWS ONTO THE BIOPROSTHETIC VALVE. PANNUS, A CAUSE OF NONSTRUCTURAL DYSFUNCTION, MAY INTERFERE WITH FUNCTIONALITY OF THE DEVICE BY RESTRICTING THE LEAFLET MOTION LEADING TO ABNORMAL COAPTATION. IN THIS CASE, AS PER PHYSICIAN¿S NOTES, THERE IS ¿NOT A CLEAR REASON WHY THE VALVE MALFUNCTIONED.¿ IT WAS MOST LIKELY RELATED TO THE MECHANISMS DESCRIBED ABOVE. 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 OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE CLINICAL SPECIALIST, A YOUNG PATIENT WITH TRANSPOSITION OF THE GREAT VESSELS HAD A SAPIEN 3 PLACED IN HER CONDUIT. IT IS UNCLEAR WHEN THE SAPIEN 3 VALVE WAS PLACED BUT THE PATIENT CAME BACK WITH VALVE FAILURE - ONE OF THE LEAFLETS WAS NOT FUNCTIONING AND APPEARED TO BE MISSING. THE PHYSICIAN SUSPECTS ENDOCARDITIS AS THE CAUSE. THE PATIENT HAD A MELODY VALVE IMPLANTED INSIDE OF THE FAILED SAPIEN 3 VALVE.

    Description of Event or Problem · 1

    AS REPORTED BY THE CLINICAL SPECIALIST, A YOUNG PATIENT WITH TRANSPOSITION OF THE GREAT VESSELS HAD A SAPIEN 3 PLACED IN HER PREVIOUSLY IMPLANTED SAPIEN XT VALVE IN THE PULMONARY POSITION. RECORDS INDICATE THERE WAS SEVERE PULMONARY REGURGITATION WITH SOME CENTRAL INSUFFICIENCY. IT WAS TREATED WITH A VALVE IN VALVE PROCEDURE WITH GOOD RESULT. THE CAUSE OF THE CENTRAL INSUFFICIENCY WAS UNCLEAR AS WORKUP FOR ENDOCARDITIS WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16125 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26A 4003310

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention