BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION

    MDR report key: 1233844 · Received November 11, 2008

    Report

    Report Number
    1820334-2008-00642
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE ANATOMICAL REQUIREMENTS, WARNINGS, PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. SPECIFICALLY, THE IFU STATES THAT KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SEVERE PROXIMAL NECK ANGULATION, SHORT PROXIMAL AORTIC NECK, AN INVERTED FUNNEL SHAPE, AND CIRCUMFERENTIAL THROMBUS AND/OR CALCIUM AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND DISTAL ILIAC ARTERY INTERFACE. IRREGULAR CALCIFICATION AND/OR PLAQUE MAY COMPROMISE THE FIXATION AND SEALING OF THE IMPLANTATION SITES. NECKS EXHIBITING THESE KEY ANATOMIC ELEMENTS MAY BE MORE CONDUCIVE TO GRAFT MIGRATION. THE DEVICE REMAINS IMPLANTED AND NO IMAGES WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THE EVENT WAS DUE TO PATIENT ANATOMY. HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE WITH A CONICAL NECK ANGLED AT 60 DEGREES RIGHT AT THE RENALS, HAD ONE FUNCTIONING KIDNEY, COPD, AND A BAD HEART UNDERWENT AAA REPAIR IN 2008. THE PHYSICIAN RAN 5MM NON CONTRAST CT AND PLACED ONE FLEX MAIN BODY, TWO ILIAC LEG GRAFTS, AND ONE AORTIC CUFF. FOLLOW UP REVEALED A LEAK AT THE JUNCTION OF THE MAIN BODY AND THE LIMB. PRIOR TO THE REPAIR, THE PATIENT ENDED UP ON DIALYSIS, SO THE PHYSICIAN DECIDED TO COVER THE RENAL. THE FIRST RUN REVEALED A PROXIMAL TYPE 1 ENDOLEAK WHICH WAS REPAIRED WITH PLACEMENT OF AN ADDITIONAL CUFF ON EIGHT MONTHS LATER. WHEN THE PHYSICIAN CANNULATED THE HYPO, HE SAW A MASSIVE TYPE II ENDOLEAK ON BOTH SIDES. ONE OFF THE BRANCH OF THE RIGHT HYPOGASTRIC AND ONE FROM THE IMA. THE PHYSICIAN COIL EMBOLIZED BOTH. PATIENT IS FINE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 1783641

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention