BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 8107214 · Received November 27, 2018

    Report

    Report Number
    2015691-2018-04899
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    November 5, 2018
    Report Date
    November 5, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS/REPLACEMENTS AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR DYSFUNCTION. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN PERFORMED; HOWEVER, THE HEALTHCARE PROVIDER HAS NOT PROVIDED ANY ADDITIONAL DETAILS REGARDING THIS EVENT. ALTHOUGH THE REASON FOR THE VALVE-IN-VALVE IS UNKNOWN, THERE HAS BEEN NO ALLEGATION OF PRODUCT MALFUNCTION OR DEFICIENCY. THE REPORTED EVENT CANNOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. THE ROOT CAUSE OF THIS EVENT REMAINS INDETERMINABLE. THE REPORTED EVENT CANNOT BE CONFIRMED SINCE THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. HOWEVER, THIS EVENT WAS MOST LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH OR WITHOUT SVD AND/OR NSVD. THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE NOT REVIEWED AS THE DEVICE SERIAL NUMBER IS UNKNOWN. "HOWEVE", 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 LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #6625-LP; BRAND NAME: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS; PMA #P870077.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THIS PATIENT WITH A BIOPROSTHETIC MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE. THE FAILURE MODE AND IMPLANT DURATION OF THE SURGICAL VALVE IS UNKNOWN. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS NOTED AS TO BE WELL. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947876 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R