BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 5115139 · Received September 30, 2015

    Report

    Report Number
    2015691-2015-02570
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 15, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATES, PER MEDICAL OPINION, THE ANNULAR RUPTURE IS THOUGHT TO BE DUE TO THE MECHANISM OF THE PROCEDURE ITSELF WITH THE BALLOON EXPANSION OF THE VALVE IN AN AREA WHERE THE CALCIFICATION HAD PROGRESSED INTO THE MITRAL CURTAIN. THE IMPLANT ITSELF WAS TECHNICALLY GOOD." LIMITED CINE IMAGES OF THE PROCEDURE WERE PROVIDED TO EDWARDS BY THE FACILITY FOR INTERNAL REVIEW. THE IMAGES WERE REVIEWED BY AN EDWARDS PHYSICIAN PROCTOR AND THE FOLLOWING OBSERVATIONS WERE MADE: ANGIOGRAPHY IMAGES: · ALL NATIVE LEAFLETS ARE SEVERELY CALCIFIED. · SEVERE AI PRESENT ON PRE-DEPLOYMENT AORTOGRAM. · CORONARIES CALCIFIED. NO CALCIUM PRESENT IN STJ. · BAV IMAGES PROVIDED NOT PROVIDED. POSSIBLE NO BAV PERFORMED. · VALVE IMAGING DEMONSTRATES GUIDE WIRE IS OFF CENTER FROM APEX. · VALVE IN GOOD POSITION PRIOR TO DEPLOYMENT · NO IMAGES OF VALVE DEPLOYMENT RECORDED. · VALVE DOES NOT APPEAR TO BE FULLY EXPANDED. POSSIBLY INTENTIONAL DUE TO ANNULAR SIZE. · POST DEPLOYMENT AORTOGRAM, CONFIRM ANNULAR RUPTURE ON RIGHT CORONARY SIDE. · VISUALIZE PERICARDIOCENTESIS CATHETER INSERTED. · SECOND VALVE PLACED MORE VENTRICLE. RUPTURE PRESENT IN FINAL IMAGES. ECHO: PROVIDED. CD NOT FUNCTIONAL. CT: NOT PROVIDED. USEFUL IN CONFIRMING VALVE SIZE. OBSERVATIONS: CANNOT CONFIRM ROOT CAUSE OF RUPTURE WITHOUT CT ANNULAR MEASUREMENTS TO CONFIRM VALVE SIZE. EVENT POSSIBLE DUE TO SEVERELY CALCIFIED NATIVE LEAFLETS.

    Additional Manufacturer Narrative · 1

    RESULT: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: KNOWN INHERENT RISK OF THE PROCEDURE. PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION 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 AORTIC DISSECTION, HEMATOMA OR ANNULAR RUPTURE DURING THE TAVR PROCEDURE INCLUDE SIGNIFICANT THV OVER SIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION AND NARROW CALCIFIED STJ. IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. 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 ANNULAR RUPTURE IS THOUGHT TO BE DUE TO THE MECHANISM DESCRIBED ABOVE. 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 AFFILIATES IN (B)(6), DURING THE IMPLANTATION OF A 23MM SAPIEN XT VALVE BY TF APPROACH IN AORTIC POSITION, THE PATIENT DIED DUE TO AN ANNULAR RUPTURE. THE IMPLANT WAS GOOD BUT WHEN PERFORMING THE POST IMPLANT ROOT ECHO, THE IMPLANT TEAM NOTED A CONTRAST LEAK, SUSPICIOUS FOR ANNULAR RUPTURE. EVERY EFFORT WAS MADE TO ASSIST CLOTTING IN AN ATTEMPT TO SEAL THE LEAK, AND A SECOND VALVE (23MM SAPIEN XT) WAS ALSO IMPLANTED TO TRY TO SEAL THE LEAK. UNFORTUNATELY, THE TAMPONADE COULD NOT BE STOPPED AND THE PATIENT PASSED AWAY. AS PER MEDICAL OPINION, THE ANNULAR RUPTURE IS THOUGHT TO BE DUE TO THE MECHANISM OF THE PROCEDURE ITSELF WITH THE BALLOON EXPANSION OF THE VALVE IN AN AREA WHERE THE CALCIFICATION HAD PROGRESSED INTO THE MITRAL CURTAIN. THE IMPLANT ITSELF WAS TECHNICALLY GOOD. THE NATIVE ANNULUS MEASURED 21MM2, WITH SEVERE CALCIFICATION AND MODERATE AORTIC ROOT CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646418 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| R