BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 10013984 · Received April 30, 2020

    Report

    Report Number
    2015691-2020-11728
    Event Type
    Injury
    Date Received
    April 30, 2020
    Date of Event
    March 17, 2020
    Report Date
    April 9, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), 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 NOT UNCOMMON 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 OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT DEFICIENCY CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE IN ADDITION TO THE PROCEDURE ITSELF, PATIENT FACTORS (BULKY LVOT CALCIFICATION) MAY HAVE CONTRIBUTED TO THE CRESCENTIC-SHAPED PVL AND SUBSEQUENT PLACEMENT OF 2 OCCLUDERS 1 MONTH POST VALVE IMPLANT. 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. REFERENCE FOR ARTICLE: SO CY, KANG, G LEE JC, ENG MH. THE RETRO-ANTEGRADE APPROACH TO PARAVALVULAR LEAK CLOSURE AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. EUROINTERVENTION 2020; JAA-749 2020, DOI: 10.4244/10.4244/EIJ-D-19-01122. THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-11726, AND MANUFACTURER REPORT NO: 2015691-2020-11727.

    Description of Event or Problem · 1

    AS REPORTED THROUGH AN ARTICLE, "THE RETRO-ANTEGRADE APPROACH TO PARAVALVULAR LEAK CLOSURE AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT.", PARAVALVULAR LEAK (PVL) POST-TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IS CHALLENGING TO CLOSE DUE TO THE PRESENCE OF THE TRANSCATHETER VALVE FRAME AND CALCIUM ALONG THE LEAK. A ¿RETRO-ANTEGRADE¿ APPROACH WAS ADOPTED TO FACILITATE CATHETER AND DEVICE DELIVERY IN CLOSING PVL POST SAPIEN 3 VALVE DEPLOYMENT DUE TO BULKY LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIUM. SINGLE ARTERIAL ACCESS FOR A 14FR NON-EDWARDS SHEATH WAS USED. IN THIS CASE, 1 MONTH POST SAPIEN 3 VALVE DEPLOYMENT, THE PLACEMENT OF TWO OCCLUDING DEVICES WAS PLANNED DUE TO ¿CRESCENTIC-SHAPED¿ PVL. TWO 4MM MUSCULAR VSD OCCLUDERS WERE SUCCESSFULLY PLACED REDUCING THE PVL TO MILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480097 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN 3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention