BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1984590 · Received February 2, 2011

    Report

    Report Number
    1820334-2011-00087
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 20, 2011
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OCCLUSION IS LABELED IN THE IFU. NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST WITH THIS INVESTIGATION. THIS PRODUCT LINE HAS ADDRESSED ALL DESIGN CONTROL REQUIREMENTS AND SHOWN THE DEVICE HAS MET THE PREDETERMINED REQUIREMENTS AND THAT THOSE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH DEVICE IS SENT WITH AN INSTRUCTIONS FOR USE (IFU) WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, SIZING INSTRUCTIONS, AND THE PROPER DEPLOYMENT SEQUENCE. SPECIFIC TO THIS CASE, THE IFU STATES: "INABILITY TO MAINTAIN PATENCY OF AT LEAST ONE INTERNAL ILIAC ARTERY OR OCCLUSION OF AN INDISPENSABLE INFERIOR MESENTERIC ARTERY MAY INCREASE THE RISK OF PELVIC/BOWEL ISCHEMIA." THE FAILURE MODE ASSIGNED TO THIS CASE IS DEPLOYMENT. THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. A QUALITY ENGINEERING RISK ANALYSIS (QERA) WAS PERFORMED AND NO ADD'L ACTIONS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PHYSICIAN PLACED THE IPSILATERAL LEG FIRST, AND THEN PLACED THE CONTRALATERAL LEG. DURING ANGIOGRAPHY, THE PT'S LEFT IIA COULD NOT BE FOUND. THE PHYSICIAN TRIED TO PUSH UP THE LEG WITH DELIVERY SHEATH, BUT IT COULD NOT BE MOVED. THEN THE PHYSICIAN TRIED TO CANNULATE THE WIRE GUIDE, BUT ALSO COULD NOT BE INSERTED. SO THE PHYSICIAN DID ANGIOGRAPHY AND CONFIRMED NO ENDOLEAK. THE PHYSICIAN ENDED THE PROCEDURE. THE PT KEPT UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA F2563916

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other