BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS

    MDR report key: 10955640 · Received December 6, 2020

    Report

    Report Number
    2015691-2020-14897
    Event Type
    Injury
    Date Received
    December 6, 2020
    Date of Event
    November 12, 2020
    Report Date
    November 12, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE. UPDATED D4 AND H4 PER NEW INFORMATION RECEIVED . 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.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE. UPDATED B5 PER NEW INFORMATION RECEIVED . H11: CORRECTED DATA . BASED ON THE ADDITIONAL INFORMATION OBTAINED, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND THIS CORRECTION IS BEING SUBMITTED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A PATIENT WITH A 31MM MITRAL VALVE UNDERWENT A VALVE-IN-VALVE (VIV) INTERVENTION AFTER AN IMPLANT DURATION OF 12 YEARS AND 8 MONTHS DUE TO BIOPROSTHESIS CALCIFICATION LEADING TO STENOSIS. A 29MM TRANSCATHETER VALVE WAS IMPLANTED WITHIN THE EDWARDS SURGICAL VALVE USING THE TRANSSEPTAL APPROACH. PER MEDICAL OPINION, THE SURGICAL VALVE DID NOT FAIL PREMATURELY IN THIS PATIENT. AS REPORTED VALVE DEPLOYMENT WAS SUCCESSFUL, HOWEVER IT WAS LEARNT THAT THE PATIENT DIED FEW HOURS AFTER THE PROCEDURE. PER CLINICAL OPINION THE PATIENT'S DEATH WAS NOT VALVE RELATED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL# 6625-LP, PMA# P870077. CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), AND MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE. 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. ALTHOUGH PATIENT FACTORS ARE BELIEVED TO PLAY A CRUCIAL ROLE IN THE DEVELOPMENT IN BIOPROSTHETIC TISSUE CALCIFICATION, THE UNDERLINE MECHANISM IS STILL NOT FULLY UNDERSTOOD. 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.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT A PATIENT WITH A 31MM MITRAL VALVE UNDERWENT A VALVE-IN-VALVE (VIV) INTERVENTION AFTER AN IMPLANT DURATION OF 12 YEARS AND 8 MONTHS DUE TO CALCIFICATION LEADING TO STENOSIS. A 29MM TRANSCATHETER VALVE WAS IMPLANTED. THE PATIENT DIED A FEW HOURS AFTER THE PROCEDURE. AS REPORTED THE PATIENT'S DEATH WAS NOT VALVE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420869 CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 6650

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R