BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2010847 · Received March 3, 2011

    Report

    Report Number
    2953200-2011-00593
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    March 30, 2009
    Report Date
    February 1, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P10002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ARTERIAL/VESSEL OCCLUSION). RESULTS/CONCLUSIONS: (MODERATELY TORTUOUS ILIACS BILATERALLY WITH 40% STENOSIS).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT APPROX 3 YEARS AGO FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM, 5.6CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM WITH A DISTAL DIAMETER OF 20 MM AT THE BIFURCATION. CALCIFICATION WAS NOT REPORTED. ILIACS WERE MODERATELY TORTUOUS BILATERALLY WITH 40% STENOSIS. THE RIGHT EXTERNAL AND RIGHT COMMON ILIACS HAD MULTIFOCAL STENOSIS, WITH SEVERE STENOSIS OF THE DISTAL RIGHT COMMON ILIAC ARTERY. THE AORTIC NECK WAS 54 MM LONG, 19 MM IN DIAMETER PROXIMALLY, AND 17 MM IN DIAMETER DISTALLY, WITH AN INFRARENAL ANGLE OF 40 DEGREES AND A SUPRARENAL ANGLE OF 35 DEGREES. IT WAS REPORTED THAT THIS PT WAS IMPLANTED WITH AN ENDURANT BIFURCATED STENT VIA THE RIGHT SIDE WITHOUT ENDOLEAKS, KINKING OR TWISTING. APPROX 3 WEEKS POST-IMPLANT, THE PT WAS ADMITTED FOR BACK PAIN AND DYSPNEA AND A GRAFT LIMB OCCLUSION IN THE BIFURCATED STENT GRAFT AND THE IPSILATERAL LIMB. THE INVESTIGATOR ASSESSED THAT THE OCCLUSION IS RELATED TO THE PROCEDURE AND THE DEVICE. TWENTY-THREE MONTHS AGO THE PT HAD A FEMORAL-FEMORAL BYPASS TO TREAT THE OCCLUSION OF THE RIGHT LIMB. OCCLUSION WAS NOTED AGAIN AT THE 1, 3, AND 6 MONTH F/U VISITS AFTER THIS PROCEDURE. SEVEN MONTHS AGO AND ONE MONTH AGO, CT SCANS WITH CONTRAST SHOWED A CONTINUED STENT GRAFT OCCLUSION AND STENT GRAFT THROMBOSIS. NO FURTHER INTERVENTION HAS BEEN PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. REF MFR # 2953200-2011-005392.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM NONE MIH MEDTRONIC CARDIOVASCULAR NA V00186569

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention