BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2161864 · Received July 8, 2011

    Report

    Report Number
    2953200-2011-01256
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ENDOLEAK, BILATERAL ILIAC ARTERY THROMBUS. EVALUATION, CONCLUSION: BILATERAL ILIAC ARTERY THROMBUS.

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF BILATERAL ILIAC ARTERY ANEURYSMS WITH THROMBUS, ON AN UNK DATE. AT THE TIME OF IMPLANT, THE LEFT HYPOGASTRIC ARTERY WAS OCCLUDED WITH COILS. A ROUTINE CT, ONE MONTH AGO, SHOWED THAT THE RIGHT ILIAC PORTION OF THE STENT GRAFT HAD LOST ITS SEAL, RESULTING IN A DISTAL TYPE I ENDOLEAK, AS THE THROMBUS WAS TOO SOFT TO MAINTAIN THE SEAL. APPROXIMATELY 4 WEEKS AGO, A 20X12 ANEURX BIFURCATED STENT GRAFT WAS PLACED VIA THE RIGHT SIDE. THE CONTRALATERAL GATE WAS CANNULATED VIA BRACHIAL ACCESS AND PLACED INTO THE RIGHT HYPOGASTRIC SUCCESSFULLY, FOLLOWED BY THE PLACEMENT OF ANOTHER MANUFACTURER'S STENT. 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 V00831427

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention