BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2100746 · Received May 18, 2011

    Report

    Report Number
    2953200-2011-01016
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: (ACCESS FAILURE, CONVERSION TO SURGICAL REPAIR).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED AS A MILD CALCIFICATION AND MILD TORTUOSITY IN THE ILIAC LIMBS. THE BIFURCATED STENT GRAFT (MFR REPORT# 2953200-2011-01015) AND THE CONTRALATERAL ILIAC LIMB (MFR REPORT# 2953200-2011-01016) WERE IMPLANTED. THE ANGIOGRAM REVEALED THAT THE CONTRALATERAL ILIAC LIMB WAS NOT IN THE BIFURCATED CONTRALATERAL LIMB, BUT OUTSIDE OF THE GATE. AT AN UNK TIME, THE PHYSICIAN STATED THAT THERE WAS LOSS OF GUIDEWIRE POSITIONING, RESULTING IN THE INACCURATE PLACEMENT OF THE CONTRALATERAL ILIAC LIMB. THE PHYSICIAN ELECTED TO IMPLANT A TALENT CONVERTER AND PERFORM A FEMORAL TO FEMORAL BYPASS. 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 IRELAND NA V00853854

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention