BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2080601 · Received April 22, 2011

    Report

    Report Number
    2953200-2011-00874
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ENDOLEAK). RESULTS & CONCLUSION: (ANGULATED AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.6 CM ABDOMINAL AORTIC ANEURYSM APPROX ONE MONTH AGO. THE AORTIC NECK HAD MILD CALCIFICATION, MODERATE TORTUOUSITY AND MEASURED 12 MM IN LENGTH. THE ILIAC ARTERIES HAD SEVERE TORTUOUSITY. IT WAS REPORTED THAT THE FINAL ANGIOGRAM REVEALED A PROXIMAL TYPE I ENDOLEAK AND THIS WAS ATTRIBUTED TO THE AORTIC NECK ANGULATION. THE DECISION WAS MADE TO REPAIR THE TYPE I ENDOLEAK WITH AN ENDURANT AORTIC CUFF; HOWEVER, DURING DEPLOYMENT OF THE AORTIC CUFF THE RENAL ARTERY WAS INADVERTENTLY PARTIALLY COVERED DUE TO THE ANGULATION OF THE AORTIC NECK (REF MFR# 2953200-2011-00875). A 6 MM X 27 MM BALLOON EXPANDABLE COVERED STENT WAS IMPLANTED IN THE RENAL ARTERY AND SUCCESSFULLY RESTORED BLOOD FLOW TO THE KIDNEY. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00808505

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention