BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2090096 · Received May 6, 2011

    Report

    Report Number
    1820334-2011-00228
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 7, 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) STENOSIS IS NOT SPECIFICALLY LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A (B)(6) MALE PT UNDERWENT AAA REPAIR. THE PT'S ANATOMICAL FORM WAS NOT SUITABLE FOR THE PROCEDURE BECAUSE THE PROXIMAL NECK WAS SHORT AS THE AORTA WAS ANEURYSMAL RIGHT UNDER THE RENAL ARTERIES. THEREFORE THE LEFT RENAL ARTERY HAD TO BE COVERED BY MAINBODY. THE PROCEDURE WAS CONDUCTED AS LABELED AND THE FINAL ANGIOGRAPHY SHOWED PROXIMAL TYPE I ENDOLEAK. IT WAS NOT SOLVED AFTER ADDITIONAL BALLOONING. IT BECAME MUCH BETTER AFTER PLACEMENT OF BODY EXTENSION BUT STILL PERSISTED. THE PHYSICIAN DECIDED TO TAKE A WAIT AND SEE APPROACH. (1820334-2011-00227). THEN ANGIOGRAPHY SHOWED A LEFT ADRENAL ARTERY WAS STENOSED. THE PHYSICIAN ATTEMPTED TO TREAT THE STENOSIS BUT FOUND ANOTHER ADRENAL ARTERY ABOVE, SO DECIDED TO TAKE A WAIT AND SEE APPROACH. THE PT'S CONDITION IS UNK AS NOT PROVIDED BY REPORTER.

    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 F2604455

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other