BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2985670 · Received March 1, 2013

    Report

    Report Number
    2953200-2013-00366
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHODS: FILMS. RESULTS: OCCLUSION. DISEASED NARROW DISTAL AORTA. CONCLUSION: DISEASED NARROW DISTAL AORTA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RECENT FILM REVIEW REVEALED THAT THE BIFURCATED STENT GRAFT 2816124, THE CONTRALATERAL LIMB 1610124 AND THE C ONTRALATERAL EXTENSION 161082 WERE OCCLUDED. THE NATIVE ILIAC ARTERY WAS DISEASED AND NARROW IN DIAMETER PRIOR TO THE INITIAL IMPLANTATION. THE PHYSICIAN STATED THAT THE OCCLUSION STARTED IN THE NATIVE ARTERY. DUE TO THE LOW BLOOD FLOW AND NARROW IN DIAMETER DISTAL AORTA THE STENT GRAFTS BECAME OCCLUDED STARTING IN THE NATIVE ARTERY UP TO THE AORTIC BIFURCATION OF THE BIFURCATED STENT GRAFT. THE PHYSICIAN PERFORMED A FEMORAL TO FEMORAL BYPASS AND THE BLOOD FLOW WAS RESTORED TO THE LOWER EXTREMITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89751 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01107142

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention