BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2963959 · Received February 15, 2013

    Report

    Report Number
    2953200-2013-00262
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    April 30, 2011
    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). RESULTS: LYMPHATIC COMPLICATION.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 60 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 30 MONTHS AGO. THE AORTIC NECK WAS 25-28 MM IN DIAMETER FROM PROXIMAL TO DISTAL AND 16 MM IN LENGTH. THE RIGHT ILIAC ARTERY WAS MODERATELY TORTUOUS AND THE LEFT ILIAC ARTERY WAS SEVERELY TORTUOUS. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR A LYMPH FISTULA IN THE RIGHT GROIN NINE MONTHS POST IMPLANT. THIS WAS SURGICALLY CORRECTED AND THE EVENT RESOLVED ON THE SAME DAY. THE INVESTIGATOR ASSESSED THE EVENT TO BE PROCEDURE RELATED. THE PATIENT RECOVERED AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68044 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00518734

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention