BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 9340602 · Received November 19, 2019

    Report

    Report Number
    9340602
    Event Type
    Death
    Date Received
    November 19, 2019
    Date of Event
    October 14, 2019
    Report Date
    November 6, 2019
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A MITRAL VALVE REPLACEMENT. FOLLOWING SURGERY CONTINUED TO HAVE MITRAL VALVE REGURGITATION AND WAS FOUND TO HAVE INFECTION. PATIENT DEVELOPED A LEFT FEMORAL THROMBECTOMY 3 MONTHS LATER. THE THROMBUS WAS SENT TO EXTERNAL FACILITIES FOR FURTHER TESTING AFTER HAVING A FINDING OF FUNGUS IN OUR INTERNAL MICROBIOLOGY DEPARTMENT. THE PATIENT WAS PLACED ON ANTI-FUNGAL MEDICATION. THROUGH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND EVALUATION IT WAS DISCOVERED THE PATIENT HAD FUNGAL ENDOCARDITIS. THE VALVE WAS EXPLANTED A FEW WEEKS LATER. MANUFACTURER RESPONSE FOR PERICARDIAL TISSUE HEART VALVE, EDWARDS LIFESCIENCES (PER SITE REPORTER). THEY WOULD LIKE TO OBTAIN THE VALVE FOR FURTHER EVALUATION AND WORK UP AT THEIR LABORATORY.

    Description of Event or Problem · 1

    PATIENT HAD A MITRAL VALVE REPLACEMENT. FOLLOWING SURGERY CONTINUED TO HAVE MITRAL VALVE REGURGITATION AND WAS FOUND TO HAVE INFECTION. PATIENT DEVELOPED A LEFT FEMORAL THROMBECTOMY 3 MONTHS LATER. THE THROMBUS WAS SENT TO EXTERNAL FACILITIES FOR FURTHER TESTING AFTER HAVING A FINDING OF FUNGUS IN OUR INTERNAL MICROBIOLOGY DEPARTMENT. THE PATIENT WAS PLACED ON ANTI-FUNGAL MEDICATION. THROUGH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND EVALUATION IT WAS DISCOVERED THE PATIENT HAD FUNGAL ENDOCARDITIS. THE VALVE WAS EXPLANTED A FEW WEEKS LATER. MANUFACTURER RESPONSE FOR PERICARDIAL TISSUE HEART VALVE, EDWARDS LIFESCIENCES (PER SITE REPORTER). THEY WOULD LIKE TO OBTAIN THE VALVE FOR FURTHER EVALUATION AND WORK UP AT THEIR LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138466 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES LLC 7300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA Death