BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2951098 · Received February 8, 2013

    Report

    Report Number
    2953200-2013-00218
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    May 21, 2012
    Report Date
    January 15, 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: INHERENT RISK OF PROCEDURE (HEMATOMA).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR 5.9 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY TWO YEARS AGO. THE AORTIC NECK WAS 28 MM IN DIAMETER PROXIMALLY, 36 MM DISTALLY AND 12 MM IN LENGTH. THE RIGHT ILIAC ARTERY WAS 11 MM IN DIAMETER. THE RIGHT FEMORAL ARTERY WAS 8 MM IN DIAMETER AND THE LEFT FEMORAL ARTERY WAS 7 MM IN DIAMETER. THE ILIAC ARTERIES WERE MODERATELY TORTUOUS BILATERALLY. IT WAS REPORTED THAT 15 MONTHS POST IMPLANT DURING A ROUTINE FOLLOW-UP CT SCAN, IT WAS NOTED THAT THE PATIENT HAD AN INTRAMURAL HEMATOMA. THE INTRAMURAL HEMATOMA WAS MOST LIKELY AN INFLAMMATORY TISSUE. THE PATIENT WILL BE MONITORED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55027 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00435377

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR