BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ILIAC STENT GRAFT

    MDR report key: 2830638 · Received November 13, 2012

    Report

    Report Number
    2953200-2012-02183
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 22, 2012
    Report Date
    July 30, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION). (UNKNOWN CAUSE OR LOCATION OF THE OCCLUSION). CONCLUSION: (UNKNOWN CAUSE OR LOCATION OF THE OCCLUSION).

    Description of Event or Problem · 1

    RECEIVED UPDATED INFORMATION STATING THE OCCLUSION THAT WAS PREVIOUSLY REPORTED, HAS BEEN UPDATED TO NO OCCLUSION.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.9 CM IN DIAMETER SACCULAR ABDOMINAL AORTIC ANEURYSM WAS REPORTED WITH AN INFRA-RENAL ANGLE OF 38 DEGREES. PROXIMAL AORTA WAS 33 MM IN DIAMETER AND 27 MM IN LENGTH. DISTAL AORTA WAS 30 MM IN DIAMETER. RIGHT ILIAC ARTERY WAS 11 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 9 MM IN DIAMETER. THE RIGHT AND LEFT AORTIC ILIACS WERE MILDLY TORTUOUS. THE STENT GRAFTS WERE IMPLANTED ON THE RIGHT SIDE WITH THE PLANNED FEMORAL TO FEMORAL BY-PASS TO THE LEFT SIDE WITHOUT ISSUE. IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP, THE CT WITHOUT CONTRAST DISCOVERED THE LEFT ILIAC ARTERY HAD OCCLUDED. THE INVESTIGATOR INDICATED THAT THIS WAS PREVIOUSLY SEEN, AND NOT A NEW CLINICAL EVENT. THE PHYSICIAN WILL MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00456937

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR