BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 29MM

    MDR report key: 3987646 · Received August 7, 2014

    Report

    Report Number
    2015691-2014-01808
    Event Type
    Death
    Date Received
    August 7, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    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 EXACT CAUSE OF THE ANNULAR RUPTURE COULD NOT BE CONFIRMED; HOWEVER, SEVERE CALCIFICATION OF THE AORTIC VALVE IS A RISK FACTOR FOR ANNULAR RUPTURE AND LIKELY CONTRIBUTED TO THE REPORTED EVENT. 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

    AFTER IMPLANTATION OF A 29MM SAPIEN XT VALVE, THE PATIENT LOST LOW BLOOD PRESSURE AND PULSE AND FLUORO DEMONSTRATED THAT THERE WAS NO VENTRICULAR MOTION. THE PATIENT DEVELOPED CARDIAC TAMPONADE BELIEVED TO BE FROM AN ANNULAR RUPTURE. PERICARDIOCENTESIS WAS PERFORMED BUT RESUSCITATION WAS UNSUCCESSFUL AND THE PATIENT EXPIRED. AS REPORTED, A TRANSTHORACIC ECHO (TTE) REVEALED NO AI OR NO EVIDENCE OF ¿CIRCUMFERENTIAL PERFUSION¿ AFTER VALVE DEPLOYMENT. THE NATIVE VALVE ANNULAR DIAMETER MEASURED 24.9MMX30.1MM WITH AN AREA OF 599MM2 BY CT, AND WAS SEVERELY CALCIFIED. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS FAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464609 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 29MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX29

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death