BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSACATHETER HEART VALVE

    MDR report key: 3973656 · Received August 1, 2014

    Report

    Report Number
    2015691-2014-01766
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    December 16, 2013
    Report Date
    July 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, PARAVALVULAR LEAK (PVL) IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PARAVALVULAR LEAK REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE, AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE. SOME PVL IS EXPECTED POST DEPLOYMENT. MANY CASES ARE MILD TO MODERATE, AND EITHER RESOLVE OVER TIME OR DO NOT CAUSE SYMPTOMS. OTHERS MAY BE MORE CLINICALLY SIGNIFICANT AND REQUIRE INTERVENTION. THE MECHANISM BEHIND WORSENING PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. IT IS ALSO POSSIBLE THAT THE DEGREE OF PVL WAS UNDERESTIMATED POST IMPLANT. IN THIS CASE, THE CAUSE OF THE WORSENING PVL CANNOT BE DETERMINED. 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

    IT WAS REPORTED THAT ONE MONTH POST SAPIEN THV IMPLANT, THE PATIENT WAS DIAGNOSED WITH WORSENING PVL. THE TRANSCATHETER HEART VALVE (THV) WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE. POST IMPLANT TRACE AORTIC REGURGITATION WAS OBSERVED. THE PATIENT WAS REPORTED TO HAVE LEFT THE HOSPITAL POST TAVR (DATE UNKNOWN) AGAINST MEDICAL DEVICE. APPROXIMATELY ONE MONTH POST PROCEDURE HE WAS READMITTED AND ECHOCARDIOGRAM (TEE) REVEALED SIGNIFICANT PARAVALVULAR LEAK, WHICH WAS DEEMED TO BE UNACCEPTABLE. HE ALSO HAD SEVERE MITRAL REGURGITATION AND ON PREOPERATIVE ECHOCARDIOGRAM WAS FOUND TO HAVE SEVERE TRICUSPID REGURGITATION. AFTER EXTENSIVE COUNSELING, THE DECISION WAS MADE TO EXPLANT THE THV VALVE AND MITRAL VALVE. THE THV VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE WITHOUT ANY INJURY TO THE AORTIC ANNULUS. PRIOR TO EXPLANT THE PHYSICIAN¿S NOTED THAT THE THV VALVE WAS LOCATED INSIDE THE LEAFLETS OF THE NATIVE VALVE, AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449696 EDWARDS SAPIEN TRANSACATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention