BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INTUITY ELITE VALVE SYSTEM

    MDR report key: 10829021 · Received November 12, 2020

    Report

    Report Number
    2015691-2020-14342
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 21, 2020
    Report Date
    December 17, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P150036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B4, G4, H6.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: IMAGE EVALUATION: ECHOCARDIOGRAPHY IMAGINE WAS RECEIVED AND REVIEWED BY A 3RD PARTY. THE DOWNLOADED FILES INCLUDE 1 STATIC IMAGE IN .JPG FORMAT AND 3 MOVIES (RESPECTIVELY 5, 7, AND 10 SECONDS IN DURATION) IN .MOV FORMAT. THE STATIC IMAGE AND 2 OF 3 MOVIES ARE FROM FLUOROSCOPY WITH SUPRAVALVULAR AORTOGRAPHY, AND THE OTHER MOVIE IS FROM TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE); ALL APPEAR TO HAVE BEEN ACQUIRED FROM DISPLAY MONITORS USING A HANDHELD CAMERA OR SMARTPHONE; AND ALL APPEAR TO HAVE BEEN ACQUIRED DURING THE PROCEDURE TO ATTEMPT TO PERCUTANEOUSLY TREAT THE PARAVALVULAR LEAK. THE MOVIE WITH TEE IMAGES INCLUDES A PRESUMED DATE OF PATIENT BIRTH (06/03/1944) AND DATE OF IMAGE ACQUISITION (21/10/2020); TEE IMAGES ARE LIMITED TO A SINGLE ¿X-PLANE¿ VIEW OF THE AORTIC VALVE WITH SUPERIMPOSED COLOR-FLOW DOPPLER, AND IT IS UNKNOWN AT WHAT POINT DURING THE INTERVENTION THE IMAGES WERE ACQUIRED. IMAGE QUALITY IS GOOD, BUT THE ANALYSIS IS AFFECTED BY LIMITED AMOUNT OF SUBMITTED IMAGES. FINDINGS ARE SUMMARIZED BELOW. INTRAPROCEDURAL FLUOROSCOPY AND TEE A BIOPROSTHESIS IS IN THE AORTIC POSITION. BIOPROSTHESIS LEAFLET ANATOMY AND FUNCTION IS NOT INTERROGATED. THERE IS SIGNIFICANT, PROBABLY SEVERE, AORTIC REGURGITATION WITH A PARAVALVULAR JET ORIGIN. SUBSEQUENTLY, A VASCULAR PLUG (PRESUMABLY THE AMPLATZER VASCULAR PLUG II) IS SHOWN ACROSS THE AORTIC ANNULUS, WITH LESS AORTIC REGURGITATION THAN PREVIOUSLY. IMPRESSION LIMITED SUBMITTED IMAGES REVEAL THE PRESENCE OF AN AORTIC VALVE BIOPROSTHESIS WITH SIGNIFICANT, PROBABLY SEVERE, PARAVALVULAR AORTIC REGURGITATION. ONE FLUOROSCOPY MOVIE SHOWS A VASCULAR PLUG, PRESUMABLY THE AMPLATZER II, ACROSS THE AORTIC ANNULUS, ASSOCIATED WITH LESS PARAVALVULAR AORTIC REGURGITATION.

    Additional Manufacturer Narrative · 1

    PARAVALVULAR LEAK (PVL) REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE. IT MAY OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE AT THE ANNULUS. THE MOST COMMON REASON FOR PVL IS INADEQUATE DEBRIDEMENT OF A CALCIFIED ANNULUS AND IS NOT A RESULT OF DEVICE MALFUNCTION. THERE MAY BE SMALL PVLS IDENTIFIED INTRA-OPERATIVELY OR POST-OPERATIVELY WHICH DO NOT REQUIRE ANY INTERVENTION. MOST CASES OF PVL NOTED INTRA-OPERATIVELY ARE CORRECTED WITH STANDARD SURGICAL TECHNIQUES DURING THE INITIAL IMPLANT PROCEDURE AND DO NOT LEAD TO SERIOUS INJURY OR DEATH. TECHNIQUE-RELATED FACTORS, SUCH AS INCORRECT VALVE SIZING, HAVE BEEN SHOWN TO CONTRIBUTE TO THE DEVELOPMENT OF PVL. UNDER SIZING CAN LEAD TO A GAP BETWEEN THE ANNULUS AND SEWING RING SINCE THE VALVE IMPLANTED IS TOO SMALL IN RELATION TO THE ANNULUS. THE USE OF PLEDGETED SUTURES DURING AORTIC VALVE REPLACEMENT WAS THOUGHT TO DECREASE THE INCIDENCE OF PVL. HOWEVER, RECENT STUDIES HAVE CONCLUDED THAT NON-PLEDGETED SUTURE TECHNIQUES OFFER AN EQUIVALENT ALTERNATIVE TO THE TRADITIONAL USE OF PLEDGETS DURING AORTIC VALVE REPLACEMENT, WITH NO INCREASE IN PVL RATES. ANATOMICAL FACTORS MAY CREATE DIFFICULTY SEATING THE BIOPROSTHETIC VALVE RESULTING IN PVL. THE ANATOMY OF THE ANNULUS MAY INDUCE MECHANICAL STRESSES ALONG THE RIGID BIOPROSTHETIC RING WHICH CAN INFLUENCE LONG-TERM VALVE PERFORMANCE AND DURABILITY. THE ANNULUS IS NOT A STATIC STRUCTURE AND HAS DYNAMIC CHARACTERISTICS WHICH HAVE BEEN SHOWN TO PLAY A CRITICAL ROLE IN VALVE FUNCTION AND EFFICIENCY. A DISEASED OR RIGID ANNULUS CAN POTENTIALLY INCREASE THE MECHANICAL STRESS ON THE PROSTHETIC VALVE, LEADING TO PVL. EDWARDS CONDUCTS MANUFACTURING AND INSPECTION TESTS TO ENSURE OPTIMUM FUNCTIONALITY OF EACH VALVE PRIOR TO FINAL DISTRIBUTION. SUCH TESTS USED TO EVALUATE IF EDWARDS' VALVES MEET SPECIFICATION INCLUDE FORWARD FLOW TESTING TO DETERMINE THE PRESSURE GRADIENT ACROSS THE OPEN VALVE AND A COAPTATION TEST UNDER CONSTANT HYDROSTATIC BACK PRESSURE TO VISUALLY EVALUATE THE COAPTATION OF THE LEAFLETS. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT THIS PATIENT WITH AN ELITE VALVE IMPLANTED IN THE AORTIC POSITION UNDERWENT PERCUTANEOUS INTERVENTION TO REPAIR A SEVERE PARAVALVULAR LEAK AFTER AN IMPLANT DURATION OF APPROX 1 YEAR AND 8 MONTHS. AS REPORTED, 3 ATTEMPTS WERE DONE USING A 26MM TRUE BALLOON ACROSS THE ANNULUS, BUT THE INTUITY ELITE¿S SKIRT WAS UNABLE TO BE EXPANDED AND TORRENTIAL INSUFFICIENCY STILL REMAINED. THE PATIENT WAS NOT A REDO CANDIDATE DUE TO HIS PRECARIOUS MEDICAL CONDITION THEREFORE THE PHYSICIANS DECIDED TO TRY IMPLANTING A VASCULAR PLUG. THE FIRST DEVICE USED WAS AN AMPLATZER MEASURING 10X5 HOWEVER MODERATE PVL WAS DEMONSTRATED ON TEE AND FLUORO. IT WAS REPLACED BY AN AMPLATZER II MEASURING 16MM WHICH SIGNIFICANTLY REDUCED THE AMOUNT OF PVL TO MILD, WHICH THE PHYSICIANS WERE CONTENT WITH. AS REPORTED, PATIENT HAD RESULTING MILD-MODERATE PVL AT THE TIME OF SURGERY IN (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293189 EDWARDS INTUITY ELITE VALVE SYSTEM TISSUE, HEART-VALVE LWR EDWARDS LIFESCIENCES 8300AB

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R