BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION

    MDR report key: 1894403 · Received November 9, 2010

    Report

    Report Number
    1820334-2010-00550
    Event Type
    Death
    Date Received
    November 9, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 8, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PRIOR TO EVAR, (B)(6) FEMALE PATIENT RECEIVED THE BYPASS SURGERY OF THE LEFT COMMON ILIAC ARTERY AND THE FEMORAL ARTERIES AND THE RIGHT EXTERNAL ILIAC ARTERY EMBOLIZATION WERE PERFORMED. ON (B)(6) 2010, SHE UNDERWENT AAA REPAIR. THE PROXIMAL NECK ANGLE RELATIVE TO THE LONG AXIS OF THE ANEURYSM WAS MORE THAN 100 DEGREES, AND BOTH ACCESS ROUTES WERE NOT SUITABLE. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA, AND THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED FIRST. THE PROCEDURE CONSISTED OF PLACEMENT OF A ZENITH FLEX MAIN BODY GRAFT, A ZENITH FLEX ILIAC LEG GRAFT, A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER AND A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION. THE DELIVERY SYSTEMS WERE INSERTED VIA THE ARTIFICIAL VESSEL ANASTOMOSED TO THE END OF THE LEFT COMMON ILIAC ARTERY. DURING PLACEMENT OF THE CONVERTER AFTER PLACEMENT OF THE MAINBODY, APPROX 500CC OF BLOOD LEAKED FROM THE VALVE. (1820334-2010-00551). THE ILIAC LEG GRAFT WAS PLACED. THEN THE MAIN BODY EXTENSION WAS PLACED BECAUSE A PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED; APPROX 500-1000CC OF BLOOD LEAKED FROM THE VALVE. AUTOLOGOUS BLOOD COLLECTION AND TRANSFUSION WAS PERFORMED BUT THE BLOOD PRESSURE DECREASED TO THE HALF OF NORMAL REVEL AND DID NOT INCREASE. INSERTION OF SHEATH OR CATHETER INTO THE VALVES WAS NOT PERFORMED. IT TOOK ABOUT 7 DAYS TO INCREASE THE BLOOD PRESSURE TO AROUND 100 BY TOTAL OF 10KG OF TRANSFUSION AND ADRENALINE ADMINISTRATION. THE PATIENT HAD BEEN INTUBATED FOR ARTIFICIAL RESPIRATION, AND ADMINISTERED A LARGE QUANTITY OF CARDIOTONIC BECAUSE SHE WAS IN SHOCK. SHE ALSO HAD BEEN UNDER MAINTENANCE DIALYSIS DUE TO DECLINE IN RENAL FUNCTION. THE INTUBATION COULD NOT BE REMOVED DUE TO FATIGUE OF THE RESPIRATORY MUSCLES DUE TO THOSE PROCEDURES AND TREATMENTS, AND IT CAUSED VENTILATOR-ASSOCIATED PNEUMONIA. THEN SHE DEVELOPED DISSEMINATED INTRAVASCULAR CLOTTING. ON (B)(6) 2010, THE PATIENT DECEASED OF VENTILATOR-ASSOCIATED PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2438356

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death