BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2854956 · Received November 20, 2012

    Report

    Report Number
    1820334-2012-00549
    Event Type
    Death
    Date Received
    November 20, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 23, 2012
    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

    PT WEIGHT UNK AS NOT PROVIDED BY REPORTER. (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION. ALTHOUGH WE HAVE ASKED FOR CLARIFICATION, NO RESPONSE HAS BEEN RECEIVED TO INDICATE IF THE ZENITH DEVICE CAUSED OR CONTRIBUTED TO THE PT DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A (B)(6) MALE PT UNDERWENT AAA REPAIR. THE PT PREVIOUSLY UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR CORONARY STENOSIS AND WAS SUITABLE FOR THE ENDOVASCULAR REPAIR EXCEPT THAT A COMMON ILIAC ARTERY ANEURYSM WAS DEVELOPED IN BOTH SIDES. AFTER BOTH COMMON ILIAC ARTERIES WERE COIL EMBOLIZED, A MAIN BODY AND TWO ILIAC LEG GRAFTS WERE DEPLOYED. NO ENDOLEAKS WERE OBSERVED AFTER THE PROCEDURE. THE RIGHT LEG BECAME PULSELESS THE NEXT DAY, SO REMOVAL OF CLOT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS PERFORMED. THE PT DEVELOPED VENTRICULAR FIBRILLATION ON THE SAME DAY AND WAS PLACED ON A HEART-LUNG MACHINE. HOWEVER, HE DID NOT RECOVER AND DIED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH, SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2706575

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| L| S