BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 5855079 · Received August 8, 2016

    Report

    Report Number
    2015691-2016-02375
    Event Type
    Injury
    Date Received
    August 8, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 6, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO MANUFACTURER AS IT REMAINS IMPLANTED. WITHOUT RECEIPT OF THE DEVICE NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. 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 · 1

    EDWARDS RECEIVED INFORMATION THAT A 29MM PERICARDIAL MITRAL VALVE, IMPLANTED TEN (10) YEARS, NINE (9) MONTHS AND TEN (10) DAYS, WAS DISABLED VIA A VALVE IN VALVE PROCEDURE FOR SEVERE MITRAL REGURGITATION DUE TO MITRAL VALVE PROSTHESIS DYSFUNCTION AND STENOSIS. PER OBTAINED MEDICAL RECORDS, THE PATIENT PRESENTED WITH ACUTE ON CHRONIC CONGESTIVE HEART FAILURE WITH ACUTE ON CHRONIC SYSTOLIC HEART FAILURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SHORTNESS OF BREATH, DYSPNEA ON EXERTION, AND CLASS 3 NYHA SYMPTOMS. A 29MM TRANSCATHETER VALVE WAS IMPLANTED AND INSPECTION OF THE VALVE DEMONSTRATED NO PARAVALVULAR LEAKS AND NO INSUFFICIENCY. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY COMPLICATIONS AND WAS TAKEN TO THE CARDIAC SURGICAL INTENSIVE CARE UNIT IN STABLE CONDITION. THE (B)(6) FEMALE PATIENT WAS DISCHARGED IN GOOD CONDITION ON POST-OPERATIVE DAY 11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507452 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R