BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2974385 · Received February 22, 2013

    Report

    Report Number
    2953200-2013-00330
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    February 7, 2012
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION, STENT GRAFT KINK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A LEFT ILIAC ANEURYSM APPROXIMATELY ONE YEAR AGO. VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WAS NOT REPORTED. IT WAS REPORTED THAT THE PHYSICIAN WAS CONCERNED ABOUT LIMB POSITION AT THE TIME OF PLACEMENT AND BALLOONED THE AORTIC BIFURCATION. THE PROCEDURE WAS COMPLETED AND NO PROBLEMS WERE NOTED. APPROXIMATELY THREE WEEKS AGO THE PATIENT PRESENTED WITH SIGNIFICANT CLAUDICATION. ANGIOGRAM SHOWED THE LEFT LIMB TO BE KINKED JUST DISTAL TO THE AORTIC BIFURCATION. THE PHYSICIAN TREATED THIS WITH A BALLOON EXPANDABLE BARE METAL STENT. THE PHYSICIAN BELIEVES THE EVENT WAS DUE TO THE PATIENT'S ANATOMY, AND ASSESSED THE EVENT TO NOT BE DEVICE RELATED. THE ANGIOGRAM ALSO SHOWED DEVELOPMENT OF MURAL THROMBUS IN THE RIGHT EXTERNAL ILIAC ARTERY THAT EXTENDED INTO THE DISTAL PORTION OF THE RIGHT LIMB OF THE STENT GRAFT. AS THE PATIENT WAS RECOVERING FROM AN UNRELATED SURGERY; THE PHYSICIAN PLANS TO TREAT THE PATIENT FOR THIS AT A LATER DATE TO EXCLUDE THROMBUS IN THIS AREA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78188 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01001216

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention