BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDORETURN ARTERIAL CANNULA

    MDR report key: 4201253 · Received October 27, 2014

    Report

    Report Number
    3008500478-2014-00127
    Event Type
    Death
    Date Received
    October 27, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K962858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETAINED BY THE HOSPITAL FOR EVALUATION. PLACEMENT OF THE ARTERIAL CANNULA WAS CONFIRMED BY TEE RULING OUT THE POSSIBILITY OF A PSEUDOANEURYSM OR FALSE LUMEN. AORTIC DISSECTION, A KNOWN COMPLICATION OF RETROGRADE ARTERIAL PERFUSION, OCCURS WHEN THERE IS A TEAR OF THE INNER LINING OF THE AORTA. AS A RESULT, BLOOD FLOWS THROUGH THIS NEWLY CREATED FALSE CHANNEL, WHICH RAISES A FLAP THAT CAN OCCLUDE BLOOD FLOW IN THE TRUE LUMEN. WHEN OCCLUSION OF BLOOD FLOW OCCURS, DEATH CAN RESULT. EVENTS OF AORTIC DISSECTION ARE TYPICALLY NOT RELATED TO A MALFUNCTION. THE DEVICE WAS DISCARDED BY THE HOSPITAL. A DEVICE EVALUATION WAS UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT DURING THE USE OF A 23 FRENCH ARTERIAL CANNULA THE PATIENT SUFFERED AN AORTIC DISSECTION. CONSIDERING THE PATIENT HAD A HISTORY OF THREE PRIOR CARDIAC SURGERIES, OF WHICH THE MOST RECENT WAS TWO (2) YEARS EARLIER, THE SURGEON ELECTED TO UTILIZE A MINI-THORACOTOMY APPROACH TO REPAIR A PARA-PROSTHETIC LEAK. REPORTED PATIENT COMORBIDITIES INCLUDED COPD AND A HISTORY OF TREATED MITRAL REGURGITATION WITH DYSPNEA. THE PATIENT ALSO HAD KNOWN VASCULAR DISEASE OF THE LEFT ILIAC ARTERY AND THE AORTA WAS REPORTED AS VERY ¿FRAGILE¿. TO INITIATE CARDIOPULMONARY BYPASS (CPB), THE 23 FRENCH ARTERIAL CANNULA WAS INSERTED INTO THE RIGHT FEMORAL ARTERY. TRANSESOPHAGEAL ECHO WAS USED TO CONFIRM THE DILATOR AND GUIDEWIRE WERE INSERTED INTO THE TRUE LUMEN. THE PATIENT WAS ON FULL RETROGRADE FLOW FOR BODY SIZE WITH A PRESSURE OF 200MMHG FOR TEN (10) MINUTES. THE PRESSURE ROSE SUDDENLY TO ABOUT 500 AND THE PATIENT EXPIRED. THE REPORTED CAUSE OF THE DEATH WAS A DISSECTION OF THE AORTA CAUSED BY RETROGRADE FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682312 ENDORETURN ARTERIAL CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES ER23

    Patients

    Seq Age Sex Outcome Treatment
    1 Death