BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 4863660 · Received June 23, 2015

    Report

    Report Number
    2015691-2015-01500
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    September 30, 2011
    Report Date
    May 25, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE REMAINS IMPLANTED ADDITIONAL MANUFACTURER NARRATIVE: AORTIC REGURGITATION (AR) IN BIOPROSTHETIC HEART VALVES OCCURS WHEN THE VALVE DOES NOT CLOSE PROPERLY IN DIASTOLIC PHASE, WHICH RESULTS IN RETROGRADE FLOW OF BLOOD INTO THE LEFT VENTRICLE. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION. IN THIS CASE, THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS BECAUSE IT REMAINS IMPLANTED IN THE PATIENT, AS THIS WAS A VALVE-IN-VALVE (VIV) PROCEDURE. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THIS EVENT. IF FURTHER INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS SURGICAL VALVE HAD A TRANSCATHETER VALVE IMPLANTED (VALVE-IN-VALVE) AFTER AN IMPLANT DURATION OF NINE (9) YEARS, EIGHT (8) MONTHS DUE TO AORTIC REGURGITATION. A 26MM TRANSCATHETER VALVE WAS IMPLANTED AND THERE WERE NO REPORTED COMPLICATIONS. THE PATIENT IS LISTED AS BEING DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407123 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R