BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3900330 · Received June 27, 2014

    Report

    Report Number
    2953200-2014-01300
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(40. EXACT EVENT DATE UNK.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE DIAMETER OF THE PROXIMAL NECK IS 26MM AND 20MM IN LENGTH. DEGREE OF ANGULATION WAS NOTED AS 10 DEGREES. VESSEL CALCIFICATION WAS NOTED AS MILD. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LEG PAIN AND CLAUDICATION. THE PHYSICIAN PERFORMED AN ULTRASOUND WHICH IDENTIFIED AN OCCLUSION AT THE LEFT LIMB AND EXTENDED ALL THE WAY TO THE ENTIRE CENTRAL LATERAL SIDE. THE PHYSICIAN TREATED THE PATIENT WITH THROMBOLYSIS FOR 24HRS AND PERFORMED AN INTERVENTION WHERE ANOTHER MANUFACTURER'S BARE METAL STENT WAS IMPLANTED. THE PHYSICIAN NOTED THE CAUSE OF THE OCCLUSION DUE TO THE STENT GRAFT BEING COMPRESSED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE. A REVIEW OF RETURNED ANGIO IMAGES 2-MONTHS POST-IMPLANT REVEALED THE BIFURCATE WAS POSITIONED JUST BELOW THE RENALS. THE IPSI LIMB WAS PLACED INTO THE RIGHT COMMON ILIAC, AND THE CONTRA LIMB INTO THE LEFT COMMON ILIAC ARTERY; THE LIMBS WERE CROSSED. THE CONTRA LIMB WAS COMPLETELY OCCLUDED BEGINNING AT THE FLOW DIVIDER. THE CAUSE OF THE OCCLUSION COULD NOT BE IDENTIFIED FROM THESE IMAGES. FILMS FROM THE SECONDARY PROCEDURE SHOWED THAT THE OCCLUSION WAS RESOLVED FOLLOWING THROMBOLYSIS AND PLACEMENT OF A STENT INSIDE THE CONTRA/LEFT LIMB. THE CAUSE OF THE LIMB OCCLUSION COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376570 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04170477

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention