BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACMENT HEART VALVE

    MDR report key: 9126771 · Received September 26, 2019

    Report

    Report Number
    2015691-2019-03593
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    September 4, 2019
    Report Date
    September 4, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EDWARDS RECEIVED ADDITIONAL INFORMATION THROUGH FOLLOW UP WITH THE HEALTHCARE PROVIDER.

    Additional Manufacturer Narrative · 0

    H11. CORRECTED DATA: D7.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A CLINICAL TRIAL THAT AN 27MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS AND 3 MONTHS DUE TO THICKENED AND RESTRICTED LEAFLETS, SEVERE STENOSIS, AND MODERATE CENTRAL REGURGITATION. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM VALVE SUCCESSFULLY. THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION ON POD#5. PER THE PRODUCT EVALUATION, THE REPORT OF STENOSIS AND THICKENED LEAFLETS WERE CONFIRMED THROUGH OBSERVED CALCIFICATION. IN ADDITION, ALL THREE LEAFLETS WERE HAD TEARS. CALCIFICATION WAS EVIDENT AT ALL TEARS. AS REPORTED, THE GRADIENTS OF THE 27MM AORTIC VALVE GRADIENTS WERE INCREASED ON 4-YEAR ECHO. IN ADDITION, THE PLASMA HEMOGLOBIN WAS ELEVATED TO 25.5 MG/DL AT 5-YEAR FOLLOW-UP VISIT AND ECHO SHOWED SEVERE STENOSIS AND HIGH GRADIENT.

    Additional Manufacturer Narrative · 1

    MODEL #: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #8300AB; BRAND NAME: EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE; PMA #P150036. THE DEVICE WAS RETURNED FOR EVALUATION AND THE CUSTOMER REPORT OF STENOSIS AND THICKENED LEAFLETS WAS CONFIRMED THROUGH OBSERVED CALCIFICATION. REPORT OF HIGH GRADIENT COULD NOT BE CONFIRMED THROUGH VISUAL OBSERVATIONS. AS RECEIVED, THE WIREFORM AND FRAME OF THE VALVE WAS DEFORMED AND PUSHED INWARD AROUND LEAFLETS 1 AND 3. COMMISSURE 2 WAS ALSO BENT INWARD. X-RAY DEMONSTRATED HEAVY CALCIFICATION ON ALL THREE LEAFLETS WITH EXTRINSIC CALCIFIC DEPOSITS ON BOTH THE INFLOW AND OUTFLOW SURFACES. CALCIFICATION RESTRICTED LEAFLET MOBILITY AND LED TO STENOSIS. X-RAY ALSO DEMONSTRATED WIREFORM INTACT WITH FRAME EXPANDED. HOST TISSUE ON THE STENT CIRCUMFERENCE AND FRAME WERE MODERATE AT THE INFLOW AND OUTFLOW ASPECTS. AS RECEIVED, LEAFLET 1 OF THE VALVE APPEARED MOSTLY TORN AWAY AND LEAFLET FRAGMENT WAS NOT RETURNED. LEAFLETS 2 AND 3 WERE ALSO TORN AT THE COMMISSURES AND STILL PARTIALLY ATTACHED TO THE VALVE. CALCIFICATION WAS EVIDENT AT ALL TEARS. CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. THE ROOT CAUSE FOR THE CALCIFICATION REMAINS INDETERMINABLE. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING AND STERILIZATION SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CLINICAL TRIAL THAT AN 27MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS AND 3 MONTHS DUE TO THICKENED AND RESTRICTED LEAFLETS, SEVERE STENOSIS, AND MODERATE CENTRAL REGURGITATION. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM VALVE SUCCESSFULLY. PER THE PRODUCT EVALUATION, THE REPORT OF STENOSIS AND THICKENED LEAFLETS WERE CONFIRMED THROUGH OBSERVED CALCIFICATION. IN ADDITION, ALL THREE LEAFLETS WERE HAD TEARS. CALCIFICATION WAS EVIDENT AT ALL TEARS. AS REPORTED, THE GRADIENTS OF AN 27MM AORTIC VALVE GRADIENTS WERE INCREASED ON 4-YEAR ECHO. IN ADDITION, THE PLASMA HEMOGLOBIN WAS ELEVATED TO 25.5 MG/DL AT 5-YEAR FOLLOW-UP VISIT AND ECHO SHOWED SEVERE STENOSIS AND HIGH GRADIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920482 REPLACMENT HEART VALVE LWR EDWARDS LIFESCIENCES 8300ACA27

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R