BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 6154723 · Received December 8, 2016

    Report

    Report Number
    2015691-2016-03612
    Event Type
    Death
    Date Received
    December 8, 2016
    Date of Event
    November 1, 2015
    Report Date
    November 14, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2016-03611. 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, OR IF THERE IS SYSTOLIC ANTERIOR MOTION OF THE ANTERIOR MITRAL LEAFLET (SAM). OTHER POSSIBLE CAUSES INCLUDE A HYPERCONTRACTILE LEFT VENTRICLE OR ATRIAL FIBRILLATION, CAUSING A DECREASE IN PRE-LOAD. IN THIS CASE, AS REPORTED IN THE ARTICLE, FLUOROSCOPY WAS NOT USED DURING THE DEPLOYMENT OF THE VALVE AND ¿WOULD HAVE BEEN BENEFICIAL AND PROBABLY FACILITATED THE VALVE IMPLANTATION AND HENCE, PREVENTED THE OCCURRENCE OF LVOT OBSTRUCTION¿. ADDITIONALLY, THE PATIENT¿S SEPTAL HYPERTROPHY AND ¿ACUTE (LESS THAN 120 DEGREES)¿ ANGLE OF THE AORTOMITRAL ANNULAR PLANE ARE DIRECTLY RELATED TO THE INCIDENCE OF LVOT OBSTRUCTION. THE CHF WAS LIKELY A DIRECT RESULT OF THE LVOT OBSTRUCTION AS THE WORKLOAD OF THE HEART TO EJECT BLOODFLOW FORWARD THROUGH A SMALLER LVOT INCREASED (INCREASED AFTERLOAD), EVENTUALLY CAUSING THE RESULTING CONGESTION. 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 EDWARDS (B)(4) AFFILIATE, PER ARTICLE "EDWARDS SAPIEN XT IN NATIVE STENOTIC MITRAL VALVE, OPEN TECHNIQUE ON CARDIOPULMONARY BYPASS" A SAPIEN XT 29MM VALVE WAS IMPLANTED VIA OPEN SURGERY ON BYPASS IN THE NATIVE MITRAL VALVE. THE PATIENT REMAINED ON INTRA-AORTIC BALLOON PUMP (IABP) POST-OPERATIVELY. PERIOPERATIVE ECHO SHOWED A PARTIAL LVOT OBSTRUCTION AND INCREASED GRADIENT OF 35MMHG BUT PHYSICIANS FOUND THAT ACCEPTABLE. OVER THE NEXT TWO DAYS, THE PATIENT DEVELOPED SIGNS OF CHF AND REQUIRED INCREASING AMOUNTS OF INTRAVENOUS MEDICATIONS FOR BLOOD PRESSURE SUPPORT. AN ADDITIONAL OPEN SURGERY WAS REQUIRED IN WHICH A MODIFIED KONNO PROCEDURE WITH MYECTOMY OF THE SEPTUM WAS PERFORMED. THE PATIENT DIED ON POST-OPERATIVE DAY #25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806659 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX29

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death