BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEE H10.

    MDR report key: 12788987 · Received November 10, 2021

    Report

    Report Number
    2015691-2021-06241
    Event Type
    Death
    Date Received
    November 10, 2021
    Report Date
    December 14, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10.
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE CAUSE OF THE EVENT CANNOT BE DETERMINED; HOWEVER, PATIENT FACTORS AND PROGRESSION OF UNDERLYING VALVULAR DISEASE LIKELY CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS, MODEL# 2800, PMA# P860057/S001. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED WHEN NEW INFORMATION IS RECEIVED. STENOSIS, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES. ADDITIONALLY, THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. SVD, A COMMON REASON FOR BIOPROSTHESIS EXPLANT OR REOPERATION, ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFIC AND NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES, OCCURRING SINGULARLY OR CONCOMITANTLY, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. THE CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. 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 · 0

    EDWARDS RECEIVED NOTIFICATION THAT SEVERE AORTIC STENOSIS WAS OBSERVED ON A 27MM AORTIC VALVE IMPLANTED IN THE AORTIC POSITION AFTER AN IMPLANT DURATION OF APPROX. 7 YEARS. IT WAS REPORTED THAT THE PATIENT DIED DUE TO HEART FAILURE AND STENOSIS SOME TIME AFTER THE DIAGNOSIS OF STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684865 SEE H10. REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES SEE H10. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death| L