BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER

    MDR report key: 11940269 · Received June 4, 2021

    Report

    Report Number
    2015691-2021-03317
    Event Type
    Death
    Date Received
    June 4, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 4, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    UDI-DI
    00690103194340
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LVOT OBSTRUCTION IN PATIENTS WHO UNDERGO TRANSCATHETER MITRAL VALVE REPLACEMENT IS A WELL RECOGNIZED POSTOPERATIVE COMPLICATION. IN MOST CASES OF POSTOPERATIVE LVOT OBSTRUCTION, THE OBSTRUCTION RESULTS FROM THE PROTRUSION OF THE VALVE INTO THE LVOT OR FROM ABNORMAL SUBVALVULAR POSITIONING OF THE PROSTHESIS. ADDITIONALLY, LVOT OBSTRUCTION MAY OCCUR POSTOPERATIVELY IF THERE IS A NARROWED MITRAL AORTIC ANGLE, OR DUE TO A THICKENED INTERVENTRICULAR SEPTUM. OTHER POSSIBLE CAUSES INCLUDE A HYPER CONTRACTILE LEFT VENTRICLE OR ATRIAL FIBRILLATION. OBSTRUCTION OF THE LEFT VENTRICULAR OUTFLOW TRACT CAN ALSO BE CAUSED BY PATIENT FACTORS (ANTERIOR MITRAL LEAFLET PROTRUDING INTO THE LVOT) OR PROCEDURAL FACTORS (POSITIONING OF THE VALVE FRAME WITHIN THE ANNULUS). DEPENDING ON THE DEGREE OF OBSTRUCTION, CARDIAC OUTPUT AND HEMODYNAMIC STABILITY MAY BE AFFECTED. INACCURATE DEPLOYMENT IS GENERALLY A RESULT OF USE ERROR OR A COMBINATION OR PATIENT AND PROCEDURAL FACTORS. IN SOME CASES LVOT OBSTRUCTION COULD RESULT IN CLINICALLY SIGNIFICANT HEMODYNAMIC COMPROMISE THAT MAY REQUIRE EXPLANATION OF THE THV WITH SURGICAL CORRECTION. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE FOR THE LVOT OBSTRUCTION COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. 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 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 OUR AFFILIATES IN (B)(6), PRIOR TO IMPLANT OF A 23MM SAPIEN 3 VALVE INTO A PRE EXISTING STENOSED SURGICAL VALVE IN THE MITRAL POSITION, THE PATIENT HAD METABOLIC ACIDOSIS DUE TO LOW HEMATOCRIT COUNTING. THE PATIENT WAS VERY FRAGILE DURING THE WEEKS PRIOR. IN THE BEGINNING OF THE PROCEDURE, TWO CAROTID VASCULAR FILTERS WERE IMPLANTED TO AVOID ANY NEUROLOGICAL COMPLICATIONS. HOWEVER, IT WAS DIFFICULT FOR THE OPERATOR TO RELEASE IT INTO POSITION. THE TMVR IMPLANT WAS DELAYED FOR TWO HOURS WITH THE PATIENT UNDER GENERAL ANESTHESIA. DURING THE TMVR PROCEDURE, SEPTAL PUNCTURE WAS PERFORMED, A SEPTOSTOMY WITH AN 14 MM X 40 MM WAS MADE, AND THE VALVE WAS POSITIONED IN THE MITRAL POSITION. THE PATIENT WAS MADE HYPOTENSIVE AND VASOACTIVE DRUGS AND VOLUME WERE ADMINISTRATED. THE VALVE WAS DEPLOYED WITHOUT PACING (DUE TO THE HYPOTENSION). AFTER VALVE DEPLOYMENT, THE PATIENT PEAKED AT 110\45 MMHG BUT THE HYPOTENSION RETURNED AFTER SEVERAL MINUTES. CPR WAS PERFORMED TO ELEVATE THE PRESSURE AND HELP THE DRUGS ACT FASTER; HOWEVER THE HYPOTENSION PERSISTED. AN 18 X 40 MM BALLOON WAS USED INTO LVOT IN AN ATTEMPT TO OPEN THE LVOT MORE. AFTER ONE HOUR AND HALF OF CPR, THE PATIENT EXPIRED. PER MEDICAL OPINION, THE PATIENT WAS IN A VERY FRAGILE STATE. DUE TO PATIENTS CONDITION DURING THE MONTH PRIOR TO TMVR, IT WAS NOT POSSIBLE TO PERFORM A CT SCAN WITH CONTRAST, WHICH COULD HAVE HELPED DEFINE THE NEO LVOT AREA AND EVALUATE RISK OF LVOT OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838603 EDWARDS SAPIEN 3 TRANSCATHETER PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9600TFX23A NA 00690103194340

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death