BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2963973 · Received February 15, 2013

    Report

    Report Number
    2953200-2013-00266
    Event Type
    Injury
    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). RESULTS: WOUND COMPLICATIONS.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 51 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 27 MONTHS AGO. THE AORTIC NECK WAS 19.9-21.3 MM IN DIAMETER AND 26.7 MM IN LENGTH. THE DISTAL AORTA WAS 30 MM IN DIAMETER. THE DIAMETER OF THE RIGHT ILIAC ARTERY WAS 10.8 MM, AND THE LEFT WAS 10.2 MM. THE DIAMETER OF THE RIGHT FEMORAL ARTERY WAS 7.4 MM AND THE LEFT WAS 8 MM. THE ILIAC ARTERIES WERE MILDLY TORTUOUS WITH 5% STENOSIS ON THE RIGHT, AND 15% STENOSIS ON THE LEFT. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ONE WEEK POST IMPLANT FOR A HEMATOMA IN THE RIGHT GROIN. THIS WAS SURGICALLY CORRECTED AND THE EVENT RESOLVED ON THE SAME DAY. THE PATIENT RECOVERED AND IS DOING FINE. THE INVESTIGATOR ASSESSED THE EVENT TO BE PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66654 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00782532

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention