BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2190814 · Received July 8, 2011

    Report

    Report Number
    2953200-2011-01258
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    April 6, 2010
    Report Date
    June 9, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ARTERIAL/VESSEL OCCLUSION); (TORTUOUS BILATERAL ILIAC ARTERIES). CONCLUSION: (TORTUOUS BILATERAL ILIAC ARTERIES).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.6 CM FUSIFORM ABDOMINAL AORTIC ANEURYSM, APPROX 16 MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS TORTUOUS BILATERAL ILIAC ARTERIES WITH NO STENOSIS; ANGLE BETWEEN PROXIMAL AAA NECK AND MAIN AXIS OF AAA OF 30 DEGREES; AORTIC NECK DIAMETER BELOW THE RENALS OF 28 MM; DISTAL AORTIC NECK DIAMETER OF 25 MM; AND AN AORTIC NECK LENGTH OF 25 MM. IT WAS REPORTED THERE WAS A PROXIMAL TYPE 1 ENDOLEAK THAT WAS CORRECTED BY REMODELING OF THE STENT GRAFT WITH AN AORTIC BALLOON. THE LEFT LIMB OF STENT GRAFT OCCLUDED APPROX ONE WEEK LATER. A RIGHT TO LEFT FEM-FEM CROSSOVER GRAFT WAS PERFORMED AND RIGHT ILIAC LIMB STENT GRAFT WAS PLACED AT THAT TIME. THE INVESTIGATOR ASSESSED THIS EVENT AS DEVICE AND PROCEDURE RELATED. SIX WEEKS AGO, THE PT WAS ADMITTED TO THE HOSPITAL WITH CLAUDICATION. ANOTHER STENT GRAFT OCCLUSION WAS NOTED BY CT SCAN THE FOLLOWING DAY. A RIGHT AXILLO-FEMORAL BYPASS WAS PERFORMED TO THE PRIOR RIGHT TO LEFT FEM-FEM CROSSOVER GRAFT ALONG WITH A THROMBECTOMY OF THE CROSSOVER GRAFT. THE INVESTIGATOR ASSESSED THE EVENT TO BE UNRELATED TO THE DEVICE OR PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00438835

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention