BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS

    MDR report key: 9998464 · Received April 24, 2020

    Report

    Report Number
    2015691-2020-11692
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    March 30, 2020
    Report Date
    March 31, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H11: CORRECTED DATA: CORRECTED SECTIONS F10 (DEVICE CODE), H6. BASED ON THE ADDITIONAL INFORMATION OBTAINED, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND THIS CORRECTION IS BEING SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10:  ADDITIONAL MANUFACTURER NARRATIVE: UPDATED B5 PER NEW INFO RECEIVED.  THIS DEVICE IS NOT SOLD OR MARKETED IN THE US BUT IS SIMILAR TO A DEVICE SOLD OR MARKETED IN THE US. BIOPROSTHETIC VALVES ARE PRONE TO STRUCTURAL VALVE DEGENERATION (SVD) DUE TO A GRADUAL, MULTI-YEAR PROCESS OF CALCIFICATION OF THE LEAFLETS RESULTING FROM THE PRE-EXISTING DISEASE PROCESS. IT MAY PRESENT AS REGURGITATION AND/OR STENOSIS. THIS IS AN EXPECTED AND FORESEEABLE RESULT IN VALVES THAT HAVE BEEN IMPLANTED LONG TERM AND ARE NEAR THE END OF ITS ESTABLISHED LIFE EXPECTANCY.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A 29MM VALVE IMPLANTED IN THE TRICUSPID POSITION WAS DISABLED VIA A VALVE-IN-VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF 21 YEARS AND 5 MONTHS DUE TO DEGENERATION LEADING TO STENOSIS AND REGURGITATION. A 29MM TRANSCATHETER VALVE WAS IMPLANTED WITH A PERFECT RESULT. ACCORDING TO THE PHYSICIAN, THE SURGICAL VALVE DID NOT PREMATURELY FAIL.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS BIOPROSTHESIS, MODEL# 6625, PMA# P870056. TISSUE DEGENERATION RELATED STRUCTURAL DETERIORATION EITHER CALCIFIC OR NON-CALCIFIC ARE COMMON CHRONIC FAILURE MODES FOR THIS TYPE OF BIOPROSTHETIC HEART VALVES. THE OPERATIONAL MECHANICAL STRESS AND BIOLOGICAL FACTORS ARE GENERALLY BELIEVED TO BE THE MAJOR CONTRIBUTORS TO THE NON-CALCIFIC BIOPROSTHETIC TISSUE DEGENERATION. STRUCTURAL VALVE DETERIORATION (SVD) CAN, AND TYPICALLY DOES, LEAD TO CHRONIC CENTRAL LEAKS OVER A PERIOD OF TIME. SVD IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NONCALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED. 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 NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO A MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. 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

    EDWARDS RECEIVED NOTIFICATION THAT A 29MM VALVE IMPLANTED IN THE TRICUSPID POSITION WAS DISABLED VIA A VALVE-IN-VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF 21 YEARS AND 5 MONTHS DUE TO DEGENERATION LEADING TO STENOSIS AND REGURGITATION. A 29MM TRANSCATHETER VALVE WAS IMPLANTED WITH A PERFECT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462310 CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 6650

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R