BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1810126 · Received August 17, 2010

    Report

    Report Number
    1820334-2010-00378
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 20, 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

    (B)(4). NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION. 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 AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO ENDOLEAKS, THE IFU LISTS SEVERAL WARNINGS/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECTS; ANATOMICAL CRITERIA, ANATOMICAL CONDITIONS, PROPER BALLOONING SITES. WITHOUT ADDITIONAL INFO IT IS DIFFICULT TO DETERMINE A ROOT CAUSE OR HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST AT THIS TIME THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE RESULTED IN THE REPORTED ENDOLEAK. FLOW THROUGH THE GRAFT MATERIAL IS EXPECTED TO CEASE UPON COAGULATION OF THE BLOOD IN THE DEVICE AND HEPARIN NEUTRALIZATION. AS WITH ALL ENDOLEAKS, IT IS IMPORTANT THAT THE TREATING PHYSICIAN FOLLOW THE PT'S ENDOLEAK APPROPRIATELY, AND PROVIDE FURTHER TREATMENT IF THE PHYSICIAN FEELS THE PT IS AT RISK OF ONGOING SAC PRESSURIZATION, ANEURYSM GROWTH, AND POSSIBLE RUPTURE. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR AAA REPAIR. FINAL ANGIOGRAPHY REVEALED TWO KINDS OF ENDOLEAKS; SEEMED TO BE LIKE TYPE I AROUND THE PROXIMAL NECK AND SEEMED TO BE LIKE TYPE IV ENDOLEAK AROUND THE TERMINAL AORTA. BALLOONING WAS PERFORMED AT THE PROXIMAL NECK AND THE JUNCTION PART, HOWEVER, THE ENDOLEAKS WERE NOT RESOLVED. THEN THE ENDOLEAK AROUND THE PROXIMAL NECK WAS CONSIDERED TO BE A TYPE II ENDOLEAK, AND THE ENDOLEAK AROUND THE TERMINAL AORTA WAS CONSIDERED TO BE A TYPE IV ENDOLEAK. THE PHYSICIAN DECIDED TO TAKE FOLLOW UP OBSERVATION. THE PT'S CONDITION AFTER THE PROCEDURE IS UNK.

    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 2515294

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other