BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2082744 · Received April 28, 2011

    Report

    Report Number
    1820334-2011-00202
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    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

    (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 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 INACCURATE DEPLOYMENT. THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION AS WELL AS THE PHYSICIAN'S COMMENTS: "RIGHT INTERNAL ILIAC ARTERY OCCLUSION WAS THOUGHT TO BE CAUSED SINCE BLOOD VESSEL WAS PUSHED UP WHEN THE STENT GRAFT WAS PLACED." WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ADDITIONAL ACTIONS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE ALTHOUGH THERE WAS SEVERE CIRCUMFERENTIAL CALCIFICATION IN BOTH SIDE OF ACCESS VESSEL. MOREOVER, THE PT'S COMPLICATION WAS CHRONIC RENAL FAILURE (DIALYSIS), OLD MYOCARDIAL INFARCTION, CORONARY ARTERY DISEASE AND TORPOR ON LEFT SIDE OF THE BODY AFTER ENCEPHALORRHAGIA. FINAL ANGIOGRAPHY REVEALED RIGHT INTERNAL ILIAC ARTERY WAS OCCLUDED (1820334-2011-00202) AND ALSO BLOOD FLOW TO PERIPHERAL VESSEL SEEMED WEAKENED (1830334-2011-00203). ANOTHER MANUFACTURER'S STENT WAS PLACED INTO EXTERNAL ILIAC ARTERY AND THE WRINKLES OF THE ILIAC LEG WAS SMOOTHED OUT TO ENSURE BLOOD FLOW TO PERIPHERAL VESSEL. THE PT'S CONDITION AFTER THE PROCEDURE WAS NOT PROVIDED BY REPORTER.

    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 F2539271

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention