BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 3801127 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01070
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    June 30, 2009
    Report Date
    April 11, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. SEX: FEMALE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: IT WAS REPORTED THAT THIS PATIENT EXPERIENCES REGURGITATION. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. OFTEN MODERATE TO HIGH REGURGITATION REQUIRING RE-OPERATION IN THE IMMEDIATE POST-OPERATIVE PERIOD IS DUE TO PROCEDURAL RELATED ISSUES AND IS UNRELATED TO THE DEVICE. HOWEVER, ADVANCES IN VALVE DESIGN AND BIOPROSTHETIC MATERIAL HAVE BEEN MADE WITH THE INTENTION OF REDUCING PERIVALVULAR OR CENTRAL LEAKS BY PROVIDING MORE EFFICIENT HEMODYNAMICS AND LONGER TISSUE DURABILITY. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ANY NEW INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    EDWARDS HAS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE HAS EXHIBITED SEVERE TRICUSPID REGURGITATION AT ONE (1) MONTH AND AT FOUR (4) YEARS AFTER IMPLANT. DEVICE WAS USED TO TREAT A MALE PATIENT IN HIS LATE 40'S WITH EBSTEIN'S ANOMALY. DEVICE REMAINS IMPLANTED. GENERAL SYMPTOMS NOTED: POOR APPETITE, LOSS OF BODY WEIGHT (3 KGS), WEAKNESS AND SHORTNESS OF BREATH. NO NEW SYMPTOMS WERE NOTED FOR LAST OPD.

    Description of Event or Problem · 1

    EDWARDS RECEIVED ADDITIONAL EXPERT REVIEW OF THE PATIENT'S ECHO HISTORY WHICH REVEALED MODERATE TRICUSPID REGURGITATION ONSET EARLY POST OPERATIVELY. THE TRICUSPID VALVE ANATOMY VISUALIZED FOUR (4) YEARS POST OPERATIVELY WAS ABNORMAL. FOLLOW UP WITH THE HEALTHCARE PROVIDER REVEALED THAT THE PATIENT IS OKAY AND INTERVENTION IS NOT INDICATED AT THIS TIME. THE PATIENT WILL BE FOLLOW UP BY THE OUT PATIENT DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277990 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other