BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCUOLAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2132186 · Received June 14, 2011

    Report

    Report Number
    1820334-2011-00306
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - OPEN SURGICAL REPAIR IS LABELED IN THE IFU. (B)(4) - ENDOLEAKS ARE LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE PT UNDERWENT A SECONDARY ABDOMINAL AORTIC ANEURYSM REPAIR DUE TO AN INCREASE IN SIZE OF THE ANEURYSM FROM THE TIME OF THE INITIAL IMPLANT. THE SECONDARY PROCEDURE TOOK PLACE ON (B)(6) 2011. BASED ON THE DECISION MADE TO SURGICALLY OPEN THE PT ABDOMEN, EXPOSING THE GROWING INFRARENAL AORTIC ANEURYSM. AFTER DISSECTING THE ABDOMINAL AORTIC ANEURYSM THE ZENITH STENT GRAFT WAS EXPOSED AND WAS NOTED TO BE "LEAKING" BLOOD THROUGH THE MATERIAL WITHIN A PARTICULAR SEGMENT OF THE GRAFT (THE SUPRACELIAC CLAMP WAS OPENED IN ORDER TO VISUALIZE THE BLOOD FLOWING THROUGH THE DEVICE). IT IS UNCLEAR WHETHER THE LEAK WAS INVOLVING THE SUTURES THAT HOLD THE Z-STENTS TO THE GRAFT OR IF THIS LEAK WAS INDEPENDENT OF THE SUTURES AND JUST PERTAINING TO THE GRAFT FABRIC. THE SURGEONS SUTURED THESE HOLES WITH A PROPYLENE STITCH. THEY THEN DECIDED TO EXCISE THE PORTION OF THE DEVICE THAT THEY FELT WAS LEAKING AND SEW IN A SURGICAL TUBE GRAFT. THE TUBE GRAFT BRIDGED THE PROXIMAL PORTION OF THE MAIN BODY TO THE DISTAL PORTION OF THE MAIN BODY. OPEN REPAIR WAS REQUIRED IN ORDER TO VISUALIZE AND IDENTIFY THE CAUSE OF THE PERSISTENT ENDOLEAK THAT WAS ENLARGING THE ANEURYSM. A PORTION OF THE MAIN BODY STENT GRAFT WAS SURGICALLY REMOVED FROM THE PT'S INFRARENAL AORTA. IT IS SUGGESTED THAT A TYPE III ENDOLEAK (TEAR IN THE STENT GRAFT FABRIC) OCCURRED FROM HEAVY CALCIUM RUBBING AGAINST GRAFT FABRIC AND SUTURE SITES. IT IS ALSO BELIEVED THAT THE ANEURYSM WAS ENLARGING DUE TO LUMBAR ARTERIES (TYPE II ENDOLEAK) AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCUOLAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2171572

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention