BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3944862 · Received July 18, 2014

    Report

    Report Number
    2953200-2014-01414
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AFTER THE INDEX PROCEDURE, THE PHYSICIAN IMPLANTED A TWO ENDURANT STENT GRAFTS TO RESOLVE A TYPE IB ENDOLEAK IN THE LEFT ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF RETURNED PRE-IMPLANT CTA'S REVEALED THAT THE PROXIMAL NECK WAS ANGULATED APPROXIMATELY 60 DEGREES A-P, AND THE NECK DIAMETER WAS APPROXIMATELY 27MM. THE AAA MAXIMUM DIAMETER MEASURED 8.5CM. THE LEFT COMMON ILIAC ARTERY WAS EXTREMELY TORTUOUS AND CALCIFIED. AT THE ORIGIN OF THE LEFT COMMON ILIAC THE DIAMETER WAS APPROXIMATELY 15MM, AND AT THE ILIAC BIFURCATION WAS 13MM. THE RIGHT COMMON ILIAC ARTERY DIAMETER WAS 26MM; THE RIGHT ILIAC WAS TORTUOUS AND CALCIFIED. IMAGES POST-IMPLANT REVEALED THAT THE BIFURCATE WAS IMPLANTED JUST BELOW THE RENAL ARTERIES; THE IPSILATERAL LIMB AND EXTENSION WERE PLACED INTO THE LEFT COMMON ILIAC, AND THE CONTRA LIMB CROSSED THE IPSILATERAL LIMB AND IS POSITIONED INTO THE RIGHT COMMON ILIAC. THE MAXIMUM DIAMETER AAA MEASURED 9.5CM. CONTRAST WAS SEEN IN THE PROXIMAL PORTION OF THE AAA SAC AT THE LEVEL OF THE BIFURCATE FLOW DIVIDER. THE ENDOLEAK TYPE AND CAUSE COULD NOT BE DETERMINED FROM THESE IMAGES. THERE IS ALSO A DISTAL TYPE I ENDOLEAK FROM THE LEFT LIMB. THE LEFT LIMB OD IS APPROXIMATELY 17MM AND THERE IS ALSO MINIMAL DISTAL SEAL LENGTH AS THE END OF THE LIMB ENDS JUST PROXIMAL TO THE SEVERE ILIAC ARTERY ANGULATION. THE RIGHT CONTRA LIMB ALSO HAS MINIMUM SEAL LENGTH WITHIN THE RIGHT ILIAC, BUT NO TYPE I ENDOLEAK IS VISIBLE. EARLIER POST-IMPLANT IMAGES WERE NOT PROVIDED, AND FILMS POST-SECONDARY IMPLANT TO REPAIR THE ENDOLEAK WERE NOT PROVIDED. THE CAUSE OF THE TYPE IB ENDOLEAK MAY BE DUE TO DISEASE PROGRESSION, ILIAC ARTERY TORTUOSITY, AND VESSEL MORPHOLOGY CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423034 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04002549

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention