BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2130003 · Received June 10, 2011

    Report

    Report Number
    2953200-2011-01131
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 12, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: OCCLUSION. LACK OF ANTI-CLOTTING THERAPY. CONCLUSIONS: LACK OF ANTI-CLOTTING THERAPY.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND A LEFT COMMON ILIAC ARTERY ANEURYSM APPROXIMATELY TWO MONTH AGO. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS REPORTEDLY NARROW BUT OTHERWISE UNREMARKABLE. AN ENDURANT BIFURCATED STENT GRAFT (REF MFR#2953200-2011-01130) AND IPSILATERAL EXTENSION, WERE IMPLANTED WITHOUT ISSUES. THE PATIENT WAS TAKEN OFF COUMADIN PRIOR TO THE IMPLANT AND APPARENTLY HAD NOT BEEN PLACED BACK ON THE COUMADIN. THE PATIENT PRESENTED SYMPTOMATICALLY ONE MONTH AGO WITH AN OCCLUDED LEFT SIDE. THERE WAS NO KINKING. A FEM-FEM BYPASS WAS PERFORMED TO RESOLVED THE OCCLUSION. THE EVENT IS MOST LIKELY RELATED TO THE LACK OF ANTI-CLOTTING THERAPY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00850116

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention