BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2974342 · Received February 22, 2013

    Report

    Report Number
    2953200-2013-00323
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 29, 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: INHERENT RISK OF PROCEDURE (VESSEL OCCLUSION); LACK OF INFORMATION (UNKNOWN CAUSE OF EVENT LEADING TO OCCLUSION). CONCLUSION: LACK OF INFORMATION (UNKNOWN CAUSE OF EVENT LEADING TO OCCLUSION).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 75 MM DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY TWO MONTHS AGO. THE AORTIC NECK WAS 22-23MM IN DIAMETER AND 32MM LONG. THE RIGHT COMMON ILIAC WAS 19-18MM IN DIAMETER, AND 45MM LONG. THE LEFT COMMON ILIAC WAS 8-14MM IN DIAMETER, AND 25MM LONG. THE RIGHT FEMORAL ARTERY WAS 10MM IN DIAMETER, AND THE LEFT FEMORAL ARTERY WAS 4.5MM IN DIAMETER. THE PATIENT'S LEFT LOWER EXTREMITY HAD BEEN AMPUTATED PRIOR TO THE EVAR. IT WAS REPORTED THAT FINAL IMAGING AT THE INDEX PROCEDURE SHOWED BLOOD FLOW THROUGH BOTH ILIAC ARTERIES. ON AN UNKNOWN DATE IT WAS DISCOVERED THAT THE LEFT INTERNAL ILIAC ARTERY WAS OCCLUDED. THE PHYSICIAN STATED THAT THE CAUSE OF THE OCCLUSION IS UNKNOWN, BUT MIGRATION IS ONE POSSIBILITY. THE PATIENT IS DOING FINE AND NO SECONDARY INTERVENTIONS ARE PLANNED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77765 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01707888

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR