BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2963962 · Received February 15, 2013

    Report

    Report Number
    2953200-2013-00264
    Event Type
    Death
    Date Received
    February 15, 2013
    Date of Event
    November 15, 2010
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (LYMPHATIC FISTULA).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 28 MONTHS AGO. IT WAS REPORTED THAT THE PATIENT HAD A WOUND COMPLICATION OF A LYMPHOCELE FISTULA IN THE RIGHT GROIN ONE MONTH POST IMPLANT. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND RELATED TO THE PROCEDURE. THIS WAS CORRECTED BY RE-SECTIONING OF THE LYMPHOCELE AND THE FISTULA RESOLVED. IT WAS ALSO REPORTED THE PATIENT PASSED AWAY DUE TO PULMONARY CANCER ONE YEAR POST IMPLANT. THE INVESTIGATOR ASSESSED THIS EVENT TO NOT BE RELATED TO THE STUDY DEVICE OR TO THE STUDY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68045 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00547754

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Death