BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDIOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1488693 · Received September 29, 2009

    Report

    Report Number
    1820334-2009-00555
    Event Type
    Injury
    Date Received
    September 29, 2009
    Date of Event
    August 12, 2009
    Report Date
    September 2, 2009
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZENITH DEVICE HAS COMPLETED REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU), LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS & PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO THIS FAILURE MODE, THE IFU STATES THAT INACCURATE PLACEMENT OF THE GRAFT MAY RESULT IN AN INCREASED RISK OF ENDOLEAK AND/OR MIGRATION. THE FAILURE MODE ASSIGNED TO THIS INVESTIGATION IS "INACCURATE DEPLOYMENT". THIS IS BASED ON THE PROVIDED EVENT DESCRIPTION, SPECIFICALLY THAT THE USER DEPLOYED BOTH ILIAC LIMBS MORE PROXIMAL THAN INTENDED. ADDITIONALLY, THERE WAS NO MENTION OF THIS GRAFT MIGRATING, AS THERE WAS WITH THE OTHER LEG GRAFT. THE EVENT DESCRIPTION STATED THIS LEG GRAFT WAS UNSTABLY POSITIONED. AT THIS TIME, IT IS UNCLEAR HOW THAT IS DEFINED AND WHAT THE EFFECTS OF THAT WOULD BE. WE WILL CONTINUE TO MONITOR FOR SIMILAR INCIDENTS.

    Description of Event or Problem · 1

    A MALE UNDERWENT AAA REPAIR IN 2008. THE PROCEDURE CONSISTED OF PLACEMENT OF A ZENITH MAIN BODY, TWO ZENITH ILIAC LEGS, AND WAS CONDUCTED WITHOUT REPORTED INCIDENT. IN 2009, THE PATIENT UNDERWENT A SECONDARY PROCEDURE. THE PATIENT HAD VERY TORTUOUS ILIAC ARTERIES AND IN THE INITIAL PROCEDURE, THE PHYSICIAN COULD NOT VISUALIZE THE ORIGIN OF THE HYPOGASTRIC ARTERIES CLEARLY. THE PHYSICIAN ENDED UP DEPLOYING THE ILIAC LIMBS MORE PROXIMAL THAN INTENDED, BECAUSE HE DID NOT WANT TO RISK COVERING THE HYPOGASTRIC ARTERIES. THE PATIENT CAME IN FOR A ROUTINE FOLLOW UP AND THE PHYSICIAN NOTICED THAT THE LEFT ILIAC LIMB HAD RETRACTED PROXIMALLY INTO THE ANEURYSM SAC, BUT WITHOUT AN OBVIOUS TYPE 1B ENDOLEAK (180334-2009-00556). THE PHYSICIAN ELECTED TO EXTEND BOTH LIMBS, BECAUSE ON 3D DESTRUCTION THE RIGHT LIMB WAS ALSO UNSTABLY POSITIONED. THE PHYSICIAN LANDED BOTH EXTENSIONS EXACTLY AS INTENDED AT THE HYPOGASTRIC ARTERIES ON BOTH SIDES. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDIOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 1921376

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention