BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 3973104 · Received August 1, 2014

    Report

    Report Number
    2953200-2014-01498
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.1CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE DISTAL AORTIC DIAMETER IS 29.8MM. THE RIGHT COMMON PROXIMAL ILIAC DIAMETER IS 15.2MM. THE RIGHT COMMON ILIAC DIAMETER IS 78.3MM. THE RIGHT COMMON DISTAL ILIAC DIAMETER IS 14.1MM. THE ACCESS DIAMETER (RIGHT FEMORAL) IS 12.5MM AND THE RIGHT COMMON ILIAC LENGTH IS 69MM. DURING A FOLLOW UP A CT IDENTIFIED THE ABDOMINAL AND LEFT ILIAC ANEURYSM HAS REGRESSED. A POSSIBLE TYPE III (SEPARATION) WAS IDENTIFIED ON THE RIGHT SIDE AND THE ANEURYSM IS CURRENTLY AT 8.5CM. THE CAUSE IS UNKNOWN. AN ANGIOGRAM WAS PERFORMED AND THE TYPE III ENDOLEAK WAS CONFIRMED. THE PHYSICIAN PERFORMED AN INTERVENTION WERE A 16C16X82 ENDURANT LIMB WAS PLACED INSIDE THE TWO DEVICES, POST DILATED WITH A BALLOON AND THE ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE. A REVIEW OF RETURNED FILMS FROM 3 YEARS POST-IMPLANT REVEALED THAT THE BIFURCATE WAS POSITIONED APPROXIMATELY 1CM BELOW THE RENALS. THE PROXIMAL NECK WAS ESSENTIALLY STRAIGHT. THE IPSI LIMB AND EXTENSION WERE PLACED INTO THE RCIA AND THE CONTRA LIMB AND EXTENSION INTO THE LCIA. THE MAX DIAMETER AAA IS 4.5CM, THE LCIA MAX DIAMETER IS 3.6CM AND THE RCIA MAX DIAMETER IS 8.3CM. WITHIN THE RIGHT COMMON ILIAC ANEURYSM, THERE IS A LIKELY TYPE III SEPARATION SEEN BETWEEN THE IPSI LIMB AND IPSI EXTENSION. NO DISTAL TYPE I ENDOLEAK IS SEEN. THERE IS MINIMAL OR NO DEVICE OVERLAP BETWEEN THESE 2 COMPONENTS. THE JUNCTION OF THE LIMBS ARE ANGULATED 90 DEG A-P AND 45 DEG LATERALLY. EARLIER POST-IMPLANT FILMS WERE NOT PROVIDED, AND THE AMOUNT OF OVERLAP AT IMPLANT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449860 ENDURANT BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00801651

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention