BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 7976288 · Received October 17, 2018

    Report

    Report Number
    2015691-2018-04238
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    September 24, 2018
    Report Date
    September 24, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    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. 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 CONTRIBUTING TO THE EVENT. THE REPORTED EVENT CANNOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. THE ROOT CAUSE OF THIS EVENT REMAINS INDETERMINABLE. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. IF ANY NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT THIS (B)(6) Y-O FEMALE PATIENT WITH A BIOPROSTHETIC MITRAL VALVE, IMPLANTED FOR 12 YEARS AND 8 MONTHS, UNDERWENT A VALVE-IN-VALVE PROCEDURE. THE FAILURE MODE OF THE PRE-EXISTING SURGICAL VALVE WAS NOT PROVIDED. A TMVR WAS PERFORMED WITH AN EDWARDS TRANSCATHETER VALVE USING A TRANS-SEPTAL APPROACH. THE PATIENT WAS NOTED TO BE HOSPITALIZED IN STABLE CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816709 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R