BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1193296 · Received October 7, 2008

    Report

    Report Number
    1820334-2008-00584
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 12, 2008
    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

    EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE WITH ISCHEMIC HEART DISEASE AND A PREVIOUS HISTORY OF HYPERTENSION AND PROSTATE CANCER UNDERWENT AAA REPAIR IN 2008. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR AAA REPAIR BUT THE AORTIC BIFURCATION WAS SLIGHTLY NARROW. THE PROCEDURE WENT AS LABELED. CONFIRMATORY ANGIOGRAPHY REVEALED A PROXIMAL TYPE I ENDOLEAK, AND TYPE III ENDOLEAK, AND STENOSIS (1820334-2008-00585) IN THE CONTRALATERAL ILIAC LEG GRAFT AT THE AORTIC BIFURCATION. THE PROXIMAL NECK WAS BALLOONED, BUT THE ENDOLEAK PERSISTED. THE TYPE III ENDOLEAK WAS CONFIRMED TO BE LEAKAGE FROM THE CONTRALATERAL ILIAC LEG, AND AN ADDITIONAL ILIAC LEG GRAFT WAS DEPLOYED INSIDE THE CONTRALATERAL ILIAC LEG GRAFT. AFTER THAT, THE ENDOLEAK WAS SEALED. THEN ANOTHER MANUFACTURER'S STENT WAS PLACED INSIDE THE CONTRALATERAL ILIAC LEG GRAFT AND THE STENOSIS WAS RESOLVED. THE PHYSICIAN COMMENTED THAT TYPE I ENDOLEAK MAY HAVE BEEN A RESULT OF CALCIUM. THE ENDOLEAK REMAINED AFTER BALLOONING, BUT IT WAS BELIEVED THAT THE ENDOLEAK WOULD SUBSIDE AFTER THE HEPARIN WORE OFF. PT WAS FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC. NA F2205592

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention