BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3150702 · Received June 6, 2013

    Report

    Report Number
    2953200-2013-01083
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: OCCLUSION. ANATOMY RELATED; NARROW AND TORTUOUS LEFT ILIAC ARTERY. CONCLUSION: OCCLUSION. ANATOMY RELATED; NARROW AND TORTUOUS LEFT ILIAC ARTERY.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 4.6CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 22 MM IN DIAMETER AND 16 MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 10 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 12 MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 9 MM IN DIAMETER AND THE LEFT EXTERNAL ILIAC ARTERY MEASURED 8 MM IN DIAMETER. IT WAS REPORTED THAT THE PATIENT HAD AN OCCLUSION OF THE CONTRALATERAL LIMB DUE TO STENOSIS. ANOTHER MANUFACTURE¿S 14MM STENT AND AN ENDURANT STENT GRAFT WERE IMPLANTED. THE PHYSICIAN STATED THAT THE CAUSE WAS DUE TO THE LEFT NARROW ILIAC ARTERY WITH CURVATURE WHICH WAS CHECKED BY CT BEFORE EVAR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250878 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04006724

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention