BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 7442110 · Received April 18, 2018

    Report

    Report Number
    2015691-2018-01447
    Event Type
    Death
    Date Received
    April 18, 2018
    Date of Event
    March 28, 2018
    Report Date
    March 28, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED CONFIRMED THE PATIENT EXPIRED ON POD1 AND THE CAUSE OF DEATH WAS LISTED AS MULTI-ORGAN FAILURE.  THE VALVE HAD BEEN POSITIONED VIA TRANSFEMORAL APPROACH IN A 50:50 POSITION AND DEPLOYED 70:30 AORTIC/VENTRICULAR.  THE PATIENT¿S NATIVE ANNULS MEASURED 27.5 MM BY CT AND BOTH THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT WERE NOTED AS ¿GOOD¿.  PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE.   ASCENDING AORTIC DISSECTION MAY OCCUR WHEN MULTIPLE ATTEMPTS ARE MADE TO CROSS THE STENOTIC NATIVE VALVE, AND/OR WHEN EXCESSIVE FORCE IS USED.  PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV).  THE THV TRAINING MANUALS PROVIDE GUIDANCE TO FACILITATE SAFE CROSSING OF THE NATIVE VALVE, INCLUDING CAMERA PROJECTIONS, HANDLING DURING ADVANCEMENT, AND TROUBLESHOOTING TECHNIQUES IF DIFFICULTY IS ENCOUNTERED.  AS STATED, EXCESSIVE FORCE SHOULD NOT BE USED WHEN THE DEVICE HAS DIFFICULTY CROSSING THE STENOTIC VALVE.  ADDING TENSION TO THE WIRE, PULLING BACK THE SYSTEM TO RE-ORIENT THE VALVE, AS NEEDED, AND TORQUING OF THE FLEX CATHETER MAY BE HELPFUL IN SOLVING THE PROBLEM. THE DEVICE WAS NOT RETURNED FOR EVALUATION.  HOWEVER, IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  PER REPORT, THE AORTIC DISSECTION WAS CAUSED BY PROCEDURAL FACTORS (TOP OF THE VALVE FRAME DISSECTED THE SINUS OF VALSALVA).  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 THE (B)(6) EDWARDS AFFILIATE, DURING A TAVR PROCEDURE IN THE AORTIC POSITION, THE 29MM SAPIEN 3 VALVE WAS SUCCESSFULLY IMPLANTED AND IT WAS THOUGHT TO BE A GOOD OUTCOME.  THEN THE PATIENT¿S BLOOD PRESSURE WENT DOWN AND A PERICARDIAL EFFUSION WAS SEEN BY (B)(6).  THE PERICARDIUM WAS DRAINED AND THE PATIENT STARTED TO RECOVER.  HOWEVER, AFTER ABOUT 10MINS, THE BLOOD PRESSURE WENT DOWN AGAIN AND IT WAS DECIDED TO CONVERT TO OPEN SURGERY.  IT WAS SEEN THAT THE TOP OF THE VALVE FRAME DISSECTED THE SINUS OF VALSALVA.  THE SAPIEN 3 VALVE WAS EXPLANTED AND THE DISSECTION WAS REPAIRED WITH A PERICARDIAL PATCH.  THIS REDUCED THE ANNULUS SIZE AND THEREFORE ONLY A 19MM MAGNA EASE VALVE WAS IMPLANTED.  THE PATIENT HAS PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282602 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX29

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| R