BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3160127 · Received June 10, 2013

    Report

    Report Number
    2015691-2013-20298
    Event Type
    Death
    Date Received
    June 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SERIAL NUMBER AND EXPIRATION DATE WAS PROVIDED, AND THE MANUFACTURE DATE WAS PROVIDED. REFERENCE MANUFACTURING REPORT NUMBERS 2015691-2013-20296 AND 2015691-2013-20297.

    Additional Manufacturer Narrative · 1

    REFERENCE MANUFACTURING REPORT NUMBERS 2015691-2013-20296 AND 2015691-2013-20297. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. THE SITE DECLINED TO SEND THE IMAGING TO EDWARDS LIFESCIENCES FOR REVIEW. PER THE INSTRUCTIONS FOR USE (IFU), DEVICE EMBOLIZATION AND CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY CALCIFIED AORTIC LEAFLETS, PRESERVED EJECTION FRACTION, AND LOSS OF PACING CAPTURE. IN ADDITION, THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMALLY CALCIFIED AORTIC LEAFLETS, AND LOSS OF PACING CAPTURE. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. IN PATIENTS WITH HIGH-RISK ANATOMICAL FEATURES FOR VENTRICULAR EMBOLIZATION (I.E. SMALL, CALCIFIED STJ, MINIMAL LEAFLET CALCIFICATION) AND/OR AORTIC EMBOLIZATION (I.E. MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. 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, IT APPEARS THAT MULTIPLE PATIENT AND PROCEDURAL FACTORS CAUSED OR CONTRIBUTED TO THE EVENTS OCCURRING IN THIS PROCEDURE. THE AORTIC MALPOSITION OF THE FIRST SAPIEN VALVE WAS LIKELY DUE TO THE 60:40 TO 70:30 AORTIC PRE-DEPLOYMENT POSITIONING IN COMBINATION WITH THE FAST INFLATION OF THE DELIVERY BALLOON IN THE SETTING OF BULKY CALCIFICATION. THE MODERATE-TO-SEVERE PVL NOTED FOLLOWING IMPLANT OF THE SECOND SAPIEN VALVE WAS DUE TO THE PIGTAIL CATHETER BEING STUCK BETWEEN THE TWO VALVES WITHOUT THE MEDICAL TEAM REALIZING IT. THE ANNULAR RUPTURE WAS LIKELY CAUSED BY POST DILATION WITH 1CC ADDED TO THE DELIVERY SYSTEM IN A SETTING OF BULKY CALCIFICATION AND TWO SAPIEN VALVES AND THE PIGTAIL CATHETER RESIDING IN THE NATIVE AORTIC ANNULUS. OF NOTE, THE FIRST DELIVERY BALLOON WAS UNDER-FILLED DUE TO THE DIAMETER OF THE NATIVE AORTIC ANNULUS (22.3MM BY TEE AND 21MM BY TTE FOR A 26MM SAPIEN VALVE), AND THE CORONARY SINUSES WERE EFFECTIVELY OBLITERATED BY THE SEVERELY AORTIC IMPLANTATION OF THE VALVE. THE FIRST TWO SAPIEN VALVES EMBOLIZED AS A RESULT OF THE EFFORTS TO PULL THE PIGTAIL CATHETER OUT FROM BETWEEN THEM. DUE TO THE ANNULAR RUPTURE AND TORN LEAFLETS, THERE WAS NOTHING FOR THE THIRD SAPIEN VALVE TO ANCHOR ONTO, WHICH LED TO THE VENTRICULAR MALPOSITION AND EMBOLIZATION OF THE THIRD SAPIEN VALVE INTO THE LV. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSAPICAL TAVR PROCEDURE THE 26MM SAPIEN VALVE WAS IMPLANTED IN A SEVERELY AORTIC POSITION, BARELY CAPTURING THE NATIVE AORTIC ANNULUS AND RESULTING IN MILD-TO-MODERATE PARAVALVULAR LEAK (PVL). THE MEDICAL TEAM HAD PERFORMED A ¿SOFT PREP¿ OF THE VALVE DUE TO NATIVE AORTIC ANNULAR DIAMETER READINGS OF 22.3MM BY TEE AND 21MM BY TTE. A SECOND 26MM SAPIEN VALVE WAS THEN PREPPED NORMALLY AND DEPLOYED IN A 50:50 POSITION ACROSS THE NATIVE AORTIC VALVE IN ORDER TO ¿STABILIZE¿ THE FIRST SAPIEN VALVE AND MITIGATE THE PVL. HOWEVER, THERE WAS STILL MODERATE-TO-SEVERE PVL. POST DILATION WAS PERFORMED WITH 1CC ADDED TO THE DELIVERY BALLOON, AND IT WAS OBSERVED THAT THE SAPIEN VALVE EXPANDED. THE MEDICAL TEAM NOTED THAT THE PVL RESOLVED BUT ALSO NOTED THAT THE PIGTAIL CATHETER WAS STUCK BETWEEN THE FIRST AND SECOND SAPIEN VALVES. UPON TRYING TO REMOVE THE PIGTAIL CATHETER THE TWO SAPIEN VALVES EMBOLIZED INTO THE AORTIC ARCH BUT REMAINED ON THE GUIDEWIRE. A THIRD SAPIEN VALVE WAS THEN DEPLOYED IN A 70:30 VENTRICULAR POSITION. HOWEVER, THE SAPIEN VALVE WAS NOT STABLE AND WAS NOTED TO DRIFT FURTHER VENTRICULAR. A FOURTH SAPIEN VALVE WAS THEN DEPLOYED MORE AORTIC TO THE THIRD VALVE. AT THIS TIME, THE THIRD SAPIEN VALVE EMBOLIZED INTO THE LEFT VENTRICLE (LV). THE MEDICAL TEAM CONVERTED TO OPEN HEART SURGERY AND DISCOVERED THAT THE ANNULUS HAD RUPTURED. THE PATIENT SUBSEQUENTLY EXPIRED DUE TO THE ANNULAR RUPTURE. UPON INVESTIGATION THE FOLLOWING WAS LEARNED: DURING BALLOON AORTIC VALVULOPLASTY (BAV), THE BALLOON MOVED VENTRICULAR AND WAS UNSTABLE IN THE ANNULUS. THE FIRST SAPIEN VALVE WAS INITIALLY POSITIONED APPROXIMATELY 60:40 TO 70:30 AORTIC, AND THE SURGEON PERFORMED A FAST INFLATION OF THE DELIVERY BALLOON IN THE SETTING OF BULKY CALCIFICATION WITH A RESULT OF A SEVERELY AORTIC DEPLOYMENT POSITION. PRIOR TO DEPLOYING THE SECOND SAPIEN VALVE, THE MEDICAL TEAM THOUGHT THE PIGTAIL CATHETER WAS IN THE AORTIC ARCH OR ASCENDING AORTIC, BUT IT HAD IN FACT MOVED DOWN AND ACROSS THE FIRST SAPIEN VALVE. THE PIGTAIL CATHETER WAS BEHIND THE TEE PROBE AND COULD NOT BE VISUALIZED . THE MODERATE-TO-SEVERE PVL NOTED FOLLOWING IMPLANT OF THE SECOND SAPIEN VALVE WAS DUE TO THE PIGTAIL CATHETER BEING STUCK BETWEEN THE TWO VALVES. FOLLOWING POST DILATION WITH 1CC ADDED TO THE DELIVERY BALLOON, WHILE THERE WERE TWO SAPIEN VALVES AND THE PIGTAIL CATHETER WITHIN THE NATIVE AORTIC VALVE, A CONTAINED AORTIC DISSECTION OCCURRED AND TWO NATIVE LEAFLETS WERE TORN. THE PATIENT'S DIASTOLIC BLOOD PRESSURE THEN DROPPED TO 40. IT WAS NOTED THAT THE PATIENT'S DIASTOLIC BLOOD PRESSURE WAS LOW AT THE BEGINNING OF THE TAVR PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT DUE TO THE ANNULAR RUPTURE AND TORN LEAFLETS, THERE WAS NOTHING FOR THE THIRD SAPIEN VALVE TO ANCHOR TO, WHICH LED TO THE VENTRICULAR MALPOSITION AND EMBOLIZATION OF THE THIRD SAPIEN VALVE INTO THE LV. THE AORTIC ROOT WAS MODERATELY CALCIFIED. THE SINOTUBULAR JUNCTION (STJ) DIAMETER WAS 27MM, AND THE SINUS OF VALSALVA (SOV) DIAMETER WAS 34MM. THERE WAS MILD MITRAL ANNULAR CALCIFICATION (MAC) AND MILD VENTRICULAR SEPTAL HYPERTROPHY. THE PATIENT¿S EJECTION FRACTION (EF) WAS 25%. THE IMAGE INTENSIFIER ANGLE WAS DESCRIBED AS GOOD. THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WAS DESCRIBED AS FAIR. DURING DEPLOYMENT, VENTILATION WAS NOT HELD AND THERE WAS NO LOSS OF PACING CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261227 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death