BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2051265 · Received April 6, 2011

    Report

    Report Number
    2953200-2011-00757
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: (ARTERIAL OCCLUSION), (CIRCUMFERENTIAL AORTIC MURAL THROMBUS/CALCIFICATION AND ILIAC TORTUOSITY).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.6CM DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2010. THE PATIENT HAS A HISTORY OF USE, CARDIAC DISEASE, MI, ANGINA, CAD, VASCULAR DISEASE, PVD. THERE WAS MILD RIGHT ILIAC TORTUOSITY AND MODERATE LEFT ILIAC TORTUOSITY. THERE WAS 100% CIRCUMFERENTIAL AORTIC MURAL THROMBUS/CALCIFICATION AT THE PROXIMAL NECK. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING 12 MONTHS OF LEFT LEG PAIN PRIOR TO AAA TREATMENT. AT THE TIME OF IMPLANT THE RIGHT HYPOGASTRIC ARTERY WAS EMBOLIZED. ON (B)(6) 2011, THE PATIENT HAD AN ULTRASOUND WHERE IT WAS NOTED THAT THERE WAS STENT GRAFT OCCLUSION AND STENT GRAFT STENOSIS. AN ANGIOGRAM WAS PERFORMED AND IT WAS NOTED THAT THERE WAS STENT GRAFT KINKING IN THE LEFT LIMB AS IT PASSES THROUGH THE COMMON ILIAC ARTERY. THE ANEURYSM MEASURED 57 MM IN DIAMETER. ONE WEEK PRIOR TO THIS, THE PATIENT WAS COMPLAINING OF NUMBNESS ON THE LATERAL ASPECT OF HIS RIGHT CALF. THE ULTRA SOUND CONFIRMED AN OCCLUDED RIGHT LIMB OF THE GRAFT (THIS WAS WHERE THE INTERNAL ILIAC WAS EMBOLIZED AND THE LIMB WAS EXTENDED INTO THE EXTERNAL ILIAC). ON THE LEFT SIDE A SIGNIFICANT STENOSIS IN THE COMMON ILIAC ARTERY IS NOTED. CLOPIDOGREL WAS ADMINISTERED URGENTLY TO INITIATE DUAL ANTI-PLATELET THERAPY. ANGIOPLASTY AND STENTING OF STENOSIS TO THE LEFT LIMB OF EVAR STENT GRAFT PROCEDURE WAS PERFORMED ON (B)(6) 2011. THE PATIENT RECOVERED AND WAS DISCHARGED. THE INVESTIGATOR'S ASSESSMENT STATES THAT THE STENT GRAFT OCCLUSION AND STENT GRAFT STENOSIS ARE RELATED TO THE DEVICE AND TO THE PROCEDURE (REF MFR# 2953200-2011-00758). IT WAS ALSO REPORTED THAT THE PATIENT HAD PERIPHERAL ISCHEMIA ON (B)(6) 2011. THIS WAS ASSESSED TO BE PROCEDURE RELATED AND FEM-FEM BYPASS WAS PERFORMED AND RESOLVED THE ISCHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00536520

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention