BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3953860 · Received July 23, 2014

    Report

    Report Number
    2953200-2014-01453
    Event Type
    Death
    Date Received
    July 23, 2014
    Date of Event
    October 3, 2013
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 55 MM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK HAD AN ANGLE OF 55 DEGREES. IT WAS 20.5-22.8 MM IN DIAMETER AND 10 MM IN LENGTH. THE ILIAC ARTERIES WERE MODERATELY TORTUOUS. IT WAS REPORTED THAT THE STENT GRAFT UNINTENTIONALLY COVERED THE RIGHT RENAL ARTERY. DURING THE PROCEDURE THE DEVICE WAS PULLED DOWN AND THE RIGHT RENAL ARTERY HAD PERMEABILITY ON FINAL ANGIOGRAM. IN THE FINAL ANGIOGRAM, THE PERMEABILITY OF THE RENAL ARTERY CAN BE OBSERVED AND THERE WAS NO RENAL FAILURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A UROLOGIC EVENT APPROXIMATELY THREE YEARS POST IMPLANT AND EXPIRED ONE MONTH LATER. THE PATIENT HAD CHRONIC RENAL INSUFFICIENCY DEVELOP AFTER THE PROCEDURE AND THE RIGHT RENAL ARTERY WAS UNINTENTIONALLY COVERED BY THE DEVICE AT THREE YEARS POST IMPLANT. THE PATIENT WAS ADMITTED FOR A UROLOGIC SURGERY (PROSTATIC BENIGN PATHOLOGY). THE PATIENT DEVELOPED AN INFECTIOUS COMPLICATION AND ACUTE RENAL INSUFFICIENCY. THE INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431475 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00548880

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Death