BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2003662 · Received February 24, 2011

    Report

    Report Number
    2953200-2011-00506
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF EVAL: ENDOLEAK.

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.9 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 3.5 CM LONG AND 20 MM IN DIAMETER WITH MID ANGULATION AND CALCIFICATION. THE ILIAC ARTERIES HAD MILD ANGULATION BILATERALLY AND MODERATE CALCIFICATION. IT WAS REPORTED THAT THERE MAY HAVE BEEN A TYPE III ENDOLEAK BETWEEN THE BIFURCATED STENT GRAFT AT THE GATE AND THE CONTRALATERAL LIMB. THE DECISION WAS MADE TO IMPLANT ADDITIONAL ILIAC LIMB AT THE JUNCTION BETWEEN THE GATE AND THE CONTRALATERAL LIMB; HOWEVER, THE ENDOLEAK WAS STILL PERSISTENT. (REF MFR 2953200-2011-00504 AND 2953200-2011-00505). THE ENDOLEAK WAS REVIEWED FROM AP AND LATERAL, THE PHYSICIAN DETERMINED THAT THE ENDOLEAK WAS A TYPE IV. NO FURTHER INTERVENTION WAS PERFORMED AND THE ENDOLEAK WILL BE EVALUATED AT THE 30 DAY FOLLOW-UP. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00798983

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention