BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3031653 · Received April 2, 2013

    Report

    Report Number
    2953200-2013-00601
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 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: ARTERIAL DISSECTION. DISEASED ARTERIES. GUIDE WIRE. CONCLUSION: DISEASED ARTERIES. GUIDE WIRE.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. THE PHYSICIAN PERFORMED PTA ON THE LEFT EIA DUE TO STENOSIS FOLLOWED BY IMPLANT OF AN ENDURANT BIFURCATED STENT GRAFT AND CONTRALATERAL LIMB. IT WAS REPORTED THAT DURING THE PROCEDURE A DISSECTION OF THE LEFT EIA WAS OBSERVED. IT IS UNKNOWN WHEN THE DISSECTION OCCURRED. THE PHYSICIAN IMPLANTED AN ENDURANT 101082 ILIAC STENT GRAFT TO ADDRESS THE DISSECTION. THIS RESULTED IN DIMINISHED BLOOD FLOW IN THE LEFT EIA. THE PHYSICIAN STATED THAT THE STENT GRAFT WAS NOT THE CAUSE OF THE EVENT AS THE PATIENT'S ARTERIES WERE IN POOR CONDITION. IT IS LIKELY THAT THE DISSECTION MAY HAVE OCCURRED DURING MANIPULATION OF A GUIDE WIRE AND NOT DURING DELIVERY OF THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134762 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention