BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 4112042 · Received September 23, 2014

    Report

    Report Number
    2015691-2014-02226
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) OBSTRUCTION/OCCLUSION OF THE CORONARIES. METHOD: # = DEVICE REMAINS IMPLANTED. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THIS EVENT, OR CONFIRM THE CLINICAL OBSERVATION. OCCLUSION OF THE CORONARY OSTIA IS A RECOGNIZED COMPLICATION OF AN AORTIC VALVE REPLACEMENT THAT IS TYPICALLY NOT RELATED TO A PRODUCT MALFUNCTION. 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. REFERENCE MFR REPORT #2015691-2014-02181.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT AS THIS 21 MM PERICARDIAL BIOPROSTHESIS WAS BEING TIED DOWN, THE SURGEON COULD NO LONGER SEE THE RIGHT CORONARY DUE TO THE SMALL ROOT, LEADING TO VALVULAR OBSTRUCTION. THERE WAS DIFFICULTY WEANING THE PATIENT FROM CARDIOPULMONARY BYPASS AND THE CARDIOLOGIST WAS CONSULTED TO VIEW THE TEE. DUE TO THE PATIENT'S SIZE, THEY WERE UNABLE TO FIND AN IMAGE OF ADEQUATE FLOW. THE PATIENT WAS PLACED BACK ON BYPASS AND A CORONARY ARTERY BYPASS GRAFTING (CABG) TOOK PLACE. PADDLES WERE USED TO RESTORE THE HEART TO SINUS RHYTHM AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. SHE WAS DISCHARGED HOME ON POST-OPERATIVE DAY #9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590640 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R FUROSEMIDE| ASPIRIN| LISINOPRIL| METOPROLOL| AMIODARONE