BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 3982095 · Received August 5, 2014

    Report

    Report Number
    2015691-2014-01791
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, PARAVALVULAR LEAK (PVL) IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PVL, INCLUDING DEVICE MALPOSITION, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE, BULKY OR SEVERE CALCIFICATION, AN ELLIPTICAL ANNULUS SHAPE AND VALVE UNDER-SIZING. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER AORTIC VALVE & ROOT ASSESSMENT, INCLUDING THE USE OF ECHO, AORTOGRAM AND CT TO APPROPRIATELY MEASURE THE ANNULUS DIAMETER, CONTENT AND DISTRIBUTION OF CALCIUM, AND LEAFLET CHARACTERISTICS. CONTRAINDICATIONS, IMPORTANT CONSIDERATIONS WHEN ASSESSING THE VALVE, AND CHOOSING THE PROPER THV ARE ALSO DISCUSSED. THE THV TRAINING MANUALS ALSO INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES ARE ALSO INCLUDED. IN THIS CASE, THE EXACT CAUSE OF THE PVL IS UNKNOWN. HOWEVER THE SEVERELY CALCIFIED HOMOGRAFT COULD HAVE 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 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

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING VALVE DEPLOYMENT, THE SAPIEN XT LANDED 40/60 AORTIC/VENTRICULAR (A/V), RESULTING IN MODERATE TO SEVERE PARAVALVULAR LEAK (PVL). A SECOND VALVE WAS PLACED. INITIALLY, THE PATIENT HAD A PRE-EXISTING 25MM AORTIC HOMOGRAFT. THE HOMOGRAFT WAS SEVERELY CALCIFIED WITH SEVERE INSUFFICIENCY DUE TO A FLAIL LEAFLET. THEREFORE THE PATIENT UNDERWENT A TRANSFEMORAL TAVR PROCEDURE. AN 18FR E-SHEATH WAS ADVANCED WITHOUT DIFFICULTY, AND THE BALLOON AORTIC VALVULOPLASTY (BAV) WAS OMITTED. THE 26 NOVA FLEX+ WAS PREPPED WITH NOMINAL VOLUME, ADVANCED, AND ALIGNED IN THE DESCENDING AORTA. THE BIOPROSTHETIC VALVE WAS CROSSED WITHOUT DIFFICULTY. A LOT OF MOVEMENT WAS NOTICED DURING THE DEPLOYMENT AND THE VALVE LANDED 40/60A/V. ECHO REPORTED MODERATE TO SEVERE PVL. THE TEAM DECIDED TO POST-DILATE WITH ONE ADDITIONAL CC. DURING POST DILATION, A LOT OF MOVEMENT WAS SEEN AGAIN. ECHO NOW REPORTED A REDUCTION OF PVL BUT STILL CLASSIFIED AS MILD-MODERATE. AT THIS POINT EXTENSIVE DISCUSSIONS WERE HELD REGARDING TREATMENT OPTIONS. IT BECAME APPARENT THAT THE VALVE LEFT JUST ENOUGH ROOM TO PREVENT LEAKAGE, AS THE INNER SKIRT WAS POSITIONED TOO LOW. THE TEAM DECIDED TO IMPLANT A SECOND VALVE AND TO POSITION THE SECOND VALVE ABOUT A HALF STRUT SPACE ABOVE THE FIRST VALVE. ALSO DURING ECHO EVALUATION, A PIECE OF MOVING TISSUE WAS SEEN ABOVE THE VALVE STENT. IT IS BELIEVED THAT THE FLAIL LEAFLET (FOUND PRIOR TO THE PROCEDURE) HAD TORN DURING DEPLOYMENT BUT WAS STILL ATTACHED TO THE PREVIOUSLY IMPLANTED HOMOGRAFT. WITH THE IMPLANTATION OF THE SECOND VALVE IT WAS HOPED TO PIN THE LOOSE PART OF THE LEAFLET AS WELL AS REDUCE PVL. THE SECOND VALVE WAS PREPPED WITH NOMINAL VOLUME, ADVANCED, ALIGNED AND CROSSED THE PREVIOUS IMPLANTED VALVE WITHOUT DIFFICULTY. DURING DEPLOYMENT THE VALVE WAS READJUSTED AND REMAINED IN THE PLANNED POSITION, HALF A STRUT SPACE ABOVE THE FIRST IMPLANTED VALVE. GOOD FLOW TO THE CORONARIES WAS NOTED DURING THE ROOT ANGIO. THE TORN FLAIL LEAFLET DID NOT OBSTRUCT FLOW IN ANY WAY. ECHO NOW REPORTED A TRIVIAL PVL. PATIENT WAS TRANSFERRED IN STABLE CONDITION.

    Description of Event or Problem · 1

    DURING VALVE DEPLOYMENT, THE SAPIEN XT LANDED 40/60 AORTIC/VENTRICULAR (A/V), RESULTING IN MODERATE TO SEVERE PARAVALVULAR LEAK (PVL). A SECOND VALVE WAS PLACED. INITIALLY, THE PATIENT HAD A PRE-EXISTING 25MM AORTIC HOMOGRAFT. THE HOMOGRAFT WAS SEVERELY CALCIFIED WITH SEVERE INSUFFICIENCY DUE TO A FLAIL LEAFLET. THEREFORE THE PATIENT UNDERWENT A TRANSFEMORAL TAVR PROCEDURE. AN 18FR E-SHEATH WAS ADVANCED WITHOUT DIFFICULTY, AND THE BALLOON AORTIC VALVULOPLASTY (BAV) WAS OMITTED. THE 26 NOVA FLEX+ WAS PREPPED WITH NOMINAL VOLUME, ADVANCED, AND ALIGNED IN THE DESCENDING AORTA. THE BIOPROSTHETIC VALVE WAS CROSSED WITHOUT DIFFICULTY. THE PRE-DEPLOYMENT OF THE VALVE WAS 50/50. A LOT OF MOVEMENT WAS NOTICED DURING THE DEPLOYMENT AND THE VALVE LANDED 40/60A/V. ECHO REPORTED MODERATE TO SEVERE PVL. THE TEAM DECIDED TO POST-DILATE WITH ONE ADDITIONAL CC. DURING POST DILATION, A LOT OF MOVEMENT WAS SEEN AGAIN. ECHO NOW REPORTED A REDUCTION OF PVL BUT STILL CLASSIFIED AS MILD-MODERATE. AT THIS POINT EXTENSIVE DISCUSSIONS WERE HELD REGARDING TREATMENT OPTIONS. IT BECAME APPARENT THAT THE VALVE LEFT JUST ENOUGH ROOM TO PREVENT LEAKAGE, AS THE INNER SKIRT WAS POSITIONED TOO LOW. THE TEAM DECIDED TO IMPLANT A SECOND VALVE AND TO POSITION THE SECOND VALVE ABOUT A HALF STRUT SPACE ABOVE THE FIRST VALVE. ALSO DURING ECHO EVALUATION, A PIECE OF MOVING TISSUE WAS SEEN ABOVE THE VALVE STENT. IT IS BELIEVED THAT THE FLAIL LEAFLET (FOUND PRIOR TO THE PROCEDURE) HAD TORN DURING DEPLOYMENT BUT WAS STILL ATTACHED TO THE PREVIOUSLY IMPLANTED HOMOGRAFT. WITH THE IMPLANTATION OF THE SECOND VALVE IT WAS HOPED TO PIN THE LOOSE PART OF THE LEAFLET AS WELL AS REDUCE PVL. THE SECOND VALVE WAS PREPPED WITH NOMINAL VOLUME, ADVANCED, ALIGNED AND CROSSED THE PREVIOUS IMPLANTED VALVE WITHOUT DIFFICULTY. DURING DEPLOYMENT THE VALVE WAS READJUSTED AND REMAINED IN THE PLANNED POSITION, HALF A STRUT SPACE ABOVE THE FIRST IMPLANTED VALVE. GOOD FLOW TO THE CORONARIES WAS NOTED DURING THE ROOT ANGIO. THE TORN FLAIL LEAFLET DID NOT OBSTRUCT FLOW IN ANY WAY. ECHO NOW REPORTED A TRIVIAL PVL. PATIENT WAS TRANSFERRED IN STABLE CONDITION. REGARDING THE MOVEMENT DURING VALVE DEPLOYMENT, IT WAS INDICATED THAT SOMETIMES MOVEMENT CAN OCCUR IF PACING IS NOT PREVENTING THE HEART COMPLETELY FROM ITS RAPID MOVEMENTS DURING THE CYCLE OF A HEART BEAT. PACING IS SUPPOSED TO HOLD THE HEART ¿STILL¿ BUT EVERY PATIENT IS RESPONDING DIFFERENTLY. SO DURING THE DEPLOYMENT IT WAS THE ENTIRE SYSTEM, BALLOON AND VALVE, SEEN MOVING UP AND DOWN DURING THE COURSE OF PACING/ DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457349 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention