BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 3933069 · Received July 14, 2014

    Report

    Report Number
    2015691-2014-01590
    Event Type
    Death
    Date Received
    July 14, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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, AS REPORTED, THERE WAS A LARGE PIECE OF CALCIFICATION NEAR THE NON-CORONARY CUSP WHICH LIKELY CAUSED THE ANNULAR RUPTURE. 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

    POST SAPIEN XT VALVE DEPLOYMENT, TEE REVEALED AN ANNULAR RUPTURE ON THE NON CORONARY CUSP. IT WAS REPORTED BY OUR (B)(4) AFFILIATE THAT DURING A TRANSFEMORAL TAVR PROCEDURE, THERE WAS A 5MM PIECE OF CALCIFICATION ABOVE THE RIGHT CORONARY OSTIUM. A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 23MM X 4CM EDWARDS BALLOON. CAREFULLY AS TO NOT TOUCH THE CALCIFICATION. HOWEVER WHILE PERFORMING THE BAV, CALCIFICATION ON THE LEFT CORONARY CUSP WAS PUSHED TOWARD THE SINUS OF VALSALVA. ANGIOGRAPHY PERFORMED DURING THE BAV SHOWED THAT LEAK AROUND THE BALLOON WAS TRACE, SO A 26MM SAPIEN XT VALVE WAS IMPLANTED WITH 1.5ML LESS THAN NOMINAL VOLUME. JUST AFTER IMPLANTATION A PARAVALVULAR LEAK WAS NOTED IN THE 11 TO 12 O¿CLOCK POSITION BUT IT DISAPPEARED WITHOUT POST DILATION. WHEN POST OPERATIVE ASSESSMENT WAS DONE, AND THE PROCEDURE WAS ALMOST COMPLETED, A PREMATURE VENTRICULAR CONTRACTION WAS NOTED AND THE PATIENT¿S BLOOD PRESSURE (BP) DROPPED TO 30/18MMHG. TEE SHOWED A PERICARDIAL EFFUSION AND ANGIOGRAPHY SHOWED AN ANNULUS RUPTURE ON THE NON-CORONARY CUSP SIDE. BY ADMINISTRATION OF PRESSORS AND PERFORMING BACKUP PACING, THE BP ROSE TO THE 300¿S. SURGICAL DRAINAGE WAS PERFORMED AND THE PATIENT WAS SENT TO ICU WITH PERCUTANEOUS CARDIOPULMONARY SUPPORT DEVICE (PCPS). SINCE THE PATIENT¿S FAMILY DID NOT WISH TO PERFORM A SURGICAL PROCEDURE THE PCPS WAS STOPPED AROUND MIDNIGHT AND THE PATIENT PASSED AWAY AROUND 4AM ON THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410599 SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26J

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention