BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2132210 · Received June 14, 2011

    Report

    Report Number
    1820334-2011-00317
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 27, 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). EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AN (B)(6) FEMALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR THE ENDOVASCULAR REPAIR THOUGH A PROXIMAL NECK HAD ANGLES, AND THE PROCEDURE WAS CONDUCTED AS LABELED. THE FINAL CONFIRMATORY ANGIOGRAPHY CONFIRMED SOME ENDOLEAKS. (ACT 200 APPROX 350). FOR PROXIMAL TYPE I, ADDITIONAL BALLOONING WAS PERFORMED WITH CODA FOR FURTHER SEALING. ALSO, LARGE STENT OF ANOTHER MFR WAS PLACED AT PROXIMAL NECK. SINCE TYPE III ENDOLEAK WAS ALSO SUSPICIOUS, TWO PIECES OF EXPRESS STENT AND AN ILIAC LEG WERE ADDITIONALLY PLACED AT LEFT JUNCTION PART. (1820334-2011-00318). THE LEAK WAS REDUCED BUT REMAINED. THE PROCEDURE WAS ABANDONED AT THE POINT, AND THE PHYSICIAN DECIDED THAT HE WOULD JUDGE THE TREATMENT COURSES AFTER CT TAKEN AT A LATER DATE. THERE HAS BEEN NO PT OUTCOME PROVIDED BY THE RPTR AND IMAGES WILL BE PROVIDED AT A LATER DATE. UPDATE ON (B)(6) 2011 - ANGIOGRAPHY TAKEN AT A LATER DATE CONFIRMED THAT THE ENDOLEAK WAS SOLVED. NO ADDITIONAL TREATMENT WILL BE ATTEMPTED. HOWEVER, SINCE THERE WERE MANY ENDOLEAKS OBSERVED DURING THE PROCEDURE, THERE ARE DOUBTS ABOUT MID-AND-LONG TERM EFFECTIVENESS. THE FOLLOW-UP SHOULD BE CONTINUED. ONCE ANY PROBLEM OBSERVED, ADDITIONAL TREATMENT WILL BE CONDUCTED.

    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 F2622532

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention