BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM

    MDR report key: 6172605 · Received December 13, 2016

    Report

    Report Number
    2015691-2016-03697
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 25, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT (B)(6) 2016 DURING CLOSURE REVIEW OF THE FILE, IT WAS NOTED ON THE CUSTOMER EXPERIENCE REPORT (CER) FORM THAT THE AWARE DATE WAS ENTERED INCORRECTLY. NONETHELESS, THE MDR WAS SUBMITTED ON TIME.

    Additional Manufacturer Narrative · 1

    PERICARDIAL EFFUSION IS AN ABNORMAL ACCUMULATION OF FLUID IN THE PERICARDIAL CAVITY. BECAUSE OF THE LIMITED AMOUNT OF SPACE IN THE PERICARDIAL CAVITY, FLUID ACCUMULATION WILL LEAD TO AN INCREASED INTRA PERICARDIAL PRESSURE AND THIS CAN NEGATIVELY AFFECT HEART FUNCTION. WHEN THERE IS A PERICARDIAL EFFUSION WITH ENOUGH PRESSURE TO ADVERSELY AFFECT HEART FUNCTION, THIS IS CALLED CARDIAC TAMPONADE. IT CAN BE CAUSED BY A VARIETY OF LOCAL AND SYSTEMIC DISORDERS, OR IT MAY BE IDIOPATHIC. PERICARDIAL EFFUSIONS CAN BE ACUTE OR CHRONIC, AND THE TIME COURSE OF DEVELOPMENT HAS A GREAT IMPACT ON THE PATIENT'S SYMPTOMS. IN TAVR PATIENTS, IT MAY BE CAUSED BY GUIDE WIRE PERFORATIONS OR ANNULAR RUPTURES. 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 CAUSE OF THE PERICARDIAL EFFUSION CANNOT BE DETERMINED; HOWEVER, PER REPORT IT IS MOST LIKELY RELATED TO A PROCEDURAL COMPLICATION (DEVICE MANIPULATION). 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 THROUGH OUR (B)(4) AFFILIATE, THE PATIENT DIED FROM A COMPLICATION OF A PERICARDIAL EFFUSION AFTER A TRANSFEMORAL DEPLOYMENT OF A 26MM SAPIEN 3 VALVE. AS REPORTED, THE VALVE WAS SUCCESSFULLY IMPLANTED WITH OPTIMAL POSITIONING AND NO PARAVALVULAR LEAK NOTED. AN ECHO (TEE) WAS PERFORMED POST PROCEDURE BEFORE THE PATIENT WAS TRANSFERRED FOR POST MANAGEMENT CARE. THE PATIENT WAS STABLE AND NO EVIDENCE OF AN EFFUSION, DISSECTION OR LEAK. A FEW HOURS POST PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. AN ECHO WAS PERFORMED AND REVEALED CIRCUMFERENTIAL FLUID AROUND THE HEART. A COMBINATION OF A PERICARDIAL TAP AND BLOOD TRANSFUSIONS WERE PERFORMED MULTIPLE TIMES TO DRAIN THE LATE PERICARDIAL EFFUSION. AN INCONCLUSIVE SCAN WAS PERFORMED TO OBTAIN THE CAUSE OF THE LATE TAMPONADE. THE PATIENT WENT INTO CARDIAC ARREST AND CPR WAS ADMINISTERED. SUBSEQUENTLY, THE PATIENT PASSED AWAY LATER THAT EVENING. PER REPORT, THE EVENT IS RELATED TO A PROCEDURAL COMPLICATION AND NOT WITH AN EDWARDS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823371 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention