BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2973063 · Received February 21, 2013

    Report

    Report Number
    2953200-2013-00315
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    December 26, 2012
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT KINKING); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ILIAC ARTERY ANGULATION, TYPE II ENDOLEAK). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ILIAC ARTERY ANGULATION, TYPE II ENDOLEAK).

    Description of Event or Problem · 1

    (B)(4)

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.4 CM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY EIGHT MONTHS AGO. THE INFRA-RENAL NECK ANGLE WAS 55 DEGREES. THE AORTIC NECK WAS 28 MM IN DIAMETER AND 10 MM IN LENGTH. THE RIGHT AND LEFT ILIAC ARTERIES WERE 16MM IN DIAMETER. THE DIAMETER OF THE RIGHT FEMORAL ARTERY WAS 7MM, AND THE LEFT WAS 8MM. IT WAS REPORTED THAT THERE WAS MODERATE KINKING OBSERVED IN THE LEFT CONTRALATERAL LIMB SINCE THE DATE OF THE IMPLANT PROCEDURE WHICH HAS BEEN LEFT UNCORRECTED. THE PHYSICIAN STATED THIS WAS DUE TO ANGULATION OF THE ILIAC ARTERY. IT WAS ALSO REPORTED THAT A TYPE II ENDOLEAK WAS OBSERVED ON THE IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77415 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01087775

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR