BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3172672 · Received June 17, 2013

    Report

    Report Number
    2015691-2013-20362
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE (IFU), DEVICE MALPOSITION REQUIRING INTERVENTION IS A KNOWN POTENTIAL COMPLICATION 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 VENTRICULAR MALPOSITION, 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 MALPOSITION (I.E. SMALL, CALCIFIED STJ, MINIMAL LEAFLET CALCIFICATION), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, PER THE IMPLANTING PHYSICIAN, A POOR IMAGING QUALITY ON IMAGING RESULTING IN SUB-OPTIMAL POSITIONING IN COMBINATION WITH SEVERE NATIVE AORTIC VALVE CALCIFICATION AND MODERATE AORTIC ROOT CALCIFICATION LED TO THE VENTRICULAR 65:35 VENTRICULAR IMPLANTATION OF THE SAPIEN VALVE AND SUBSEQUENT PVL. A FAIR IMAGE INTENSIFIER ANGLE AND POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM MAY HAVE ALSO CONTRIBUTED TO THE EVENT. 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 23 MM SAPIEN VALVE APPEARED BY FLUOROSCOPY TO BE POSITIONED 50:50 ACROSS THE NATIVE AORTIC ANNULUS. RAPID VENTRICULAR PACING (RVP) WAS INITIATED AND THE CINE IMAGE APPEARED VERY BLURRY. THE PHYSICIAN CAME OFF CINE, CONTINUED PACING, AND THEN TURNED ON CINE AGAIN, WHICH ALSO REVEALED A VERY BLURRY IMAGE. THE PATIENT¿S BLOOD PRESSURE WAS VERY LOW DURING THE SECOND ANGIOGRAPHY/CINE RUN, SO THE MEDICAL TEAM DECIDED TO DEPLOY THE SAPIEN VALVE. POST VALVE DEPLOYMENT, TEE REVEALED A 65:35 VENTRICULAR FINAL POSITION WITH MODERATE PARAVALVULAR LEAK (PVL) IN THE AREA OF THE LEFT ANTERIOR MITRAL LEAFLET. THE TEE ALSO REVEALED THE SAPIEN STENT WAS POORLY OPPOSED IN THE SAME POSTERIOR AREA. A SECOND 23 MM SAPIEN VALVE WAS THEN DEPLOYED 60:40 AORTIC WITHIN THE FIRST SAPIEN VALVE, WHICH YIELDED A FINAL RESULT OF TRIVIAL PVL AND ZERO CENTRAL AORTIC INSUFFICIENCY (CAI). THE APEX WAS CLOSED IN THE USUAL SURGICAL FASHION WITHOUT COMPLICATION, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. THE NATIVE AORTIC ANNULAR DIAMETER WAS 18.5 BY TEE. THE NATIVE AORTIC VALVE WAS SEVERELY CALCIFIED, AND THE AORTIC ROOT WAS MODERATELY CALCIFIED. THE DIAMETER OF THE SINOTUBULAR JUNCTION (STJ) WAS UNKNOWN. THE PATIENT¿S EJECTION FRACTION (EF) WAS 50%. THE IMAGE INTENSIFIER ANGLE WAS DESCRIBED AS FAIR. THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WAS DESCRIBED AS POOR. DURING DEPLOYMENT, VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE. BALLOON AORTIC VALVULOPLASTY (BAV) WAS NOT PERFORMED PRIOR TO VALVE DEPLOYMENT. PER THE IMPLANTING PHYSICIAN, THE PERCEIVED CAUSE OF THE VENTRICULAR MALPOSITION AND SUBSEQUENT PVL WAS A POOR CINE IMAGING QUALITY AND POSSIBLE VENTRICULAR MOVEMENT OF THE SAPIEN VALVE UPON DEPLOYMENT DUE TO HEAVY CALCIUM BURDEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273369 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention