BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3912800 · Received July 3, 2014

    Report

    Report Number
    2015691-2014-01523
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION REQUIRING INTERVENTION IS A KNOWN POTENTIAL ADVERSE EVENT 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 MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY OR SEVERELY CALCIFIED AORTIC LEAFLETS, PRESERVED EJECTION FRACTION, SIGNIFICANT MITRAL ANNULAR CALCIFICATION (MAC), LOSS OF PACING CAPTURE, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. DEPLOYMENT OF THE SAPIEN VALVE TOO AORTIC HAS THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY; IT CAN OBSTRUCT THE CORONARY OSTIA; AND LEAD TO EMBOLIZATION OF THE PROSTHESIS INTO THE ASCENDING AORTA. IN ADDITION, 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. 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 AORTIC MALPOSITION (I.E. MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. ALSO, 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, SEVERE ANNULAR AND LVOT CALCIFICATION WAS BELIEVED TO BE THE CAUSE OF THE ANNULAR RUPTURE. ADDITIONALLY THE SEVERE ANNULAR CALCIFICATION, SEVERE NATIVE LEAFLET CALCIFICATION, AND SEVERE MAC CONTRIBUTED TO THE TOO AORTIC DEPLOYMENT OF THE VALVE. 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.

    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.

    Description of Event or Problem · 1

    DURING A TAVR PROCEDURE, AN ANNULAR RUPTURE OCCURRED, AND A SECOND VALVE DEPLOYED FOR REPAIR. IT WAS REPORTED THAT DURING A TRANSFEMORAL TAVR PROCEDURE, A 26MM SAPIEN VALVE WAS POSITIONED 50/50 WITHIN THE NATIVE ANNULUS; AND WAS DEPLOYED 80/20 AORTIC/VENTRICULAR. FOLLOWING THE DEPLOYMENT THE PATIENT¿S BLOOD PRESSURE DID NOT RECOVER. TEE SHOWED THE RIGHT HEART WAS SEVERELY DEPRESSED. MULTIPLE PRESSORS WERE GIVEN. OVER THE COURSE OF 10 MINUTES THE PATIENT¿S SYSTOLIC BLOOD PRESSURE CAME BACK TO 80MMHG AND RIGHT HEART FUNCTION WAS SLIGHTLY BETTER. AN IABP WAS PREPARED AND PLACED. TEE SHOWED MILD TO MODERATE CENTRAL REGURGITATION. FURTHER TEE EVALUATION SHOWED A VENTRICULAR SEPTAL DEFECT (VSD) FROM THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT); JUST BELOW THE VALVE INTO THE RIGHT VENTRICLE. THE VSD WAS BELIEVED TO BE AN ANNULAR RUPTURE CAUSED FROM THE SEVERE ANNULAR AND LVOT CALCIFICATION. THE VSD MEASURED 6-7MM IN DIAMETER AND NO TAMPONADE WAS PRESENT. MULTIPLE OPTIONS WERE DISCUSSED, AND IT WAS DECIDED TO TRY AND SEAL WITH A SECOND VALVE, PLACED LOWER THAN THE FIRST. A SECOND VALVE WAS PREPPED AND PLACED 50/50 OVER THE FIRST, PLACING THE SKIRT LOWER INTO THE LVOT. INITIALLY THE LEAK LOOKED BETTER; HOWEVER AFTER WATCHING FOR 10 MINUTES THE LEAK SEEMED TO HAVE INCREASED FLOW. ALSO NOTICED ON TEE WAS THE RUPTURE LOOKED TO BEGIN TO EXTEND INTO THE SEPTUM. NO FURTHER MEASURES COULD BE TAKEN, TEE SHOWED MILD CENTRAL REGURGITATION. THE PATIENT REMAINED STABLE ON THE IABP AND WAS TRANSFERRED TO THE UNIT FOR MANAGEMENT. ADDITIONAL INFORMATION RECEIVED REVEALED 2 DAYS FOLLOWING THE TAVR PROCEDURE THE PATIENT PASSED AWAY. THERE WAS SEVERE NATIVE VALVE/LEAFLET CALCIFICATION, SEVERE AORTIC ROOT CALCIFICATION, AND SEVERE MITRAL ANNULAR CALCIFICATION (MAC). THE PATIENT HAD MILD SEPTAL HYPERTROPHY. THE IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT OF DELIVERY SYSTEM AND VALVE WERE REPORTED TO BE GOOD. VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391676 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention