BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4946159 · Received July 28, 2015

    Report

    Report Number
    2015691-2015-01854
    Event Type
    Death
    Date Received
    July 28, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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, PATIENT FACTORS (FEMALE GENDER, AGE, LVOT CALCIFICATION, FRIABLE TISSUE) LIKELY CONTRIBUTED TO THIS EVENT, AND ULTIMATELY THE PATIENT¿S DEATH.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

    DURING THE TRANSFEMORAL TAVR PROCEDURE, FOLLOWING PLACEMENT OF A 16FR ESHEATH, SOME DIFFICULTY CROSSING THE NATIVE VALVE WITH THE WIRE WAS ENCOUNTERED; MULTIPLE ATTEMPTS WERE REQUIRED FOR SUCCESSFUL PLACEMENT. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITHOUT COMPLICATION. A 23MM SAPIEN XT VALVE AND NOVAFLEX+ (NF+) DELIVERY SYSTEM (DS) WERE PREPARED 1.5CC LESS THAN NOMINAL VOLUME (15.5CC). THE VALVE / DS WAS ADVANCED AND POSITIONED WITHOUT DIFFICULTY. VENTILATIONS WERE HELD AND THERE WAS GOOD PACING CAPTURE WITH NO LOSS OF CAPTURE. DURING DEPLOYMENT, THE VALVE SHIFTED A BIT VENTRICULAR. THE DS WAS ADJUSTED AORTIC AND THE VALVE WAS ULTIMATELY DEPLOYED 50:50 TO 60:40 AORTIC/VENTRICULAR (A/V). FOLLOWING DEPLOYMENT, SYSTOLIC BLOOD PRESSURE (BP) ROSE ONLY TO HIGH 50S/60S MMHG. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) INDICATED THE VALVE LOOKED GOOD WITH MILD PARAVALVULAR LEAK (PVL). HOWEVER, THE BP THEN DROPPED TO 30 MMHG SYSTOLIC. TEE INDICATED A LARGE PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED AND 120CC OF BLOOD WAS OBTAINED, WITH SOME IMMEDIATE IMPROVEMENT IN THE SYSTOLIC BP. BLOOD CONTINUED TO BE PULLED OUT OF THE CENTESIS LINE (MULTIPLE 60CC SYRINGES ¿ UNKNOWN AMOUNT) AND AUTO-TRANSFUSED BACK INTO THE PATIENT. TEE WAS REPEATED. THERE APPEARED TO BE A ROOT RUPTURE, ALTHOUGH THE EXACT LOCATION COULD NOT BE DETERMINED. THE PATIENT WAS PLACED ON BYPASS. AFTER OPENING THE CHEST, THE SURGEON DETERMINED THAT THE RUPTURE WAS BELOW THE AORTIC ANNULUS, JUST INTO THE VENTRICLE BELOW THE COMMISSURE BETWEEN THE LCC AND RCC. THE XT VALVE WAS EXPLANTED AND ATTEMPTS TO REPAIR THE VENTRICLE WERE MADE BUT THE TISSUE WAS VERY FRIABLE. FOLLOWING VENTRICULAR REPAIR, A SURGICAL BIOPROSTHETIC VALVE WAS SUTURED IN PLACE. HOWEVER, THE PATIENT ULTIMATELY EXPIRED ON THE TABLE AS THE RIGHT ATRIUM COULD NOT BE SEALED AND THE RIGHT VENTRICLE TISSUES WERE FRIABLE AND DIFFICULT TO SEW. POST-CASE ANGIOGRAM REVIEW INDICATED A SMALL PIECE OF CALCIUM IN THIS LOCATION MOVING OUTWARD TO THE EDGE OF THE AORTA/LVOT AREA. THIS SMALL PIECE OF CALCIUM IN THE LVOT WAS OBSERVED ON CT PRIOR TO THE CASE. THE VALVE WAS UNDERSIZED AND DEPLOYMENT WAS PERFORMED VERY SLOWLY. IT WAS PERCEIVED THAT THE RUPTURE LIKELY OCCURRED DUE TO THE SHIFTING PIECE OF CALCIUM IN THE LVOT, UNDER THE COMMISSURE BETWEEN THE LCC AND RCC. DURING DEPLOYMENT, THE CALCIUM WENT THROUGH THE VENTRICLE/LVOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488632 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| R