BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2003586 · Received February 22, 2011

    Report

    Report Number
    2953200-2011-00479
    Event Type
    Injury
    Date Received
    February 22, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK), (SEVERELY ANGULATED AND TORTUOUS VESSEL). EVAL, CONCLUSION: (SEVERELY ANGULATED AND TORTUOUS VESSEL).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYS WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.2 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 20-21 MM IN DIAMETER AND 10 MM LONG WITHOUT ANGULATION OR CALCIFICATION, BUT HAD THROMBUS. THE COMMON ILIAC ARTERIES WERE ACUTELY ANGLED AT ABOUT 80 DEGREES, AND THE RIGHT ILIAC HAD STENOSIS WITH CALCIUM. IT WAS REPORTED THAT THE ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED VIA THE RIGHT SIDE, AND A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED, DUE TO THE THROMBOSED AORTIC NECK. ALSO, A TYPE IV BLUSH WAS SEEN NEAR THE FLOW DIVIDER AND THE TYPE IV ENDOLEAK WAS LEFT UNTREATED. AN ENDURANT AORTIC CUFF (REF MFR 2953200-2011-00478) WAS PLACED PROXIMALLY TO TREAT THE TYPE I ENDOLEAK; HOWEVER, THE TYPE I ENDOLEAK WAS STILL PRESENT, SO A PALMAZ STENT WAS PLACED, WHICH RESOLVED THE TYPE I LEAK. IN ADDITION, AS A PREVENTIVE MEASURE DUE TO THE SEVERELY ACUTELY ANGLED ILIAC ARTERY, ANOTHER MFR'S BALLOON EXPANDABLE STENTS WERE PLACED INTO THE IPSILATERAL LIMB AND CONTRALATERAL LIMB (REF MFR 2953200-2011-00480) IN THE DISTAL AORTA AND DILATED. 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 V00797247

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention