BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4792622 · Received May 22, 2015

    Report

    Report Number
    2015691-2015-01198
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ACCORDING TO THE THV TRAINING MANUALS, RISK FACTORS FOR ACUTE AORTIC RUPTURE/DISSECTION IN THE TAVR PROCEDURE INCLUDE SIGNIFICANT VALVE OVER SIZING (I.E. =4MM) IN THE PRESENCE OF SEVERELY CALCIFIED AORTIC ROOT AND OBLITERATED SINUSES. THE SAPIEN VALVE RELIES ON NATIVE VALVE CALCIUM TO SECURELY ANCHOR TO THE ANNULUS. DESPITE THIS BENEFICIAL ASPECT OF CALCIUM, BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE, WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE AND PROCEDURAL SUCCESS. IN THIS CASE, THE SOV RUPTURE WAS ATTRIBUTED TO PATIENT FACTORS [ANNULAR CALCIFICATION BREAKING THROUGH THE SOV]. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY OUR (B)(6) AFFILIATE, A SINUS OF VALSALVA (SOV) RUPTURE WAS FOUND POST DEPLOYMENT OF A 23MM SAPIEN XT VALVE. THE XT VALVE WAS IMPLANTED WITH NOMINAL VOLUME. FOLLOWING IMPLANTATION, THE ANGIOGRAPHY SHOWED A CONTRAST LEAK FROM THE RIGHT CORONARY ARTERY (RCA) SIDE OF THE SOV. THE ECHOCARDIOGRAM SHOWED NO PERICARDIAL EFFUSION AND THE PATIENT¿S HEMODYNAMICS WERE UNCHANGED, SO THE PROCEDURE WAS FINISHED. POST PROCEDURAL CT SHOWED THAT THE CALCIFICATION BROKE THROUGH THE SOV FROM THE RCA SIDE OF THE AORTIC ANNULUS. SINCE THERE WAS LESS BLEEDING VOLUME AND THE HEMODYNAMICS WERE UNCHANGED, THE PATIENT WAS UNDER FOLLOW-UP OBSERVATION. THE AORTIC ANNULUS DIAMETER MEASURED 21.0MM BY CT WITH MODERATE VALVE CALCIFICATION AND MODERATE AORTIC ROOT CALCIFICATION. THE SINOTUBULAR JUNCTION (STJ) DIAMETER MEASURED 23.0MM AND THE SOV DIAMETER MEASURED 27.0MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333760 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23J 4110022

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention