BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3903142 · Received June 30, 2014

    Report

    Report Number
    2953200-2014-01313
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 10, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: IMPLANTING DEVICE IN A SHORT AND ANGULATED AORTIC NECK.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS SHORT AND ANGULATED. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN. THE CT REVEALED THAT THERE WAS STENT GRAFT OCCLUSION. THE PHYSICIAN STATED THE RISKS ASSOCIATED WITH TRYING TO REMOVE THE BLOOD CLOT WERE TOO HIGH CONSIDERING THE EXTREMELY HOSTILE AORTIC NECK. THE PHYSICIAN ELECTED TO PERFORM A FEMORAL TO FEMORAL BYPASS AND THE BLOOD WAS RESTORED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. FILMS WERE REVIEWED; REVIEW OF PRE-IMPLANT CTA'S REVEALED THAT THE PATIENT HAD A 5 CM MAXIMUM DIAMETER AAA, WHICH CONTAINED THROMBUS (2CM AVERAGE FLOW LUMEN DIAMETER). THE PROXIMAL NECK WAS ANGULATED 50DEG (L-R), AND THE NECK DIAMETER (FLOW LUMEN) JUST BELOW THE RENAL ARTERIES WAS 20 X 18MM. THE DISTAL AORTIC DIAMETER WAS APPROXIMATELY 15MM AND CALCIFIED. THE TAKE-OFF OF THE LEFT COMMON ILIAC ARTERY WAS ACUTELY ANGULATED APPROXIMATELY 90 DEG, AND VERY CALCIFIED. THE LCIA DIAMETER WAS 10MM. THE RIGHT COMMON ILIAC ARTERY WAS MILDLY CALCIFIED/TORTUOUS. THE RGIA DIAMETER WAS 13 - 9MM. THE EXTERNALS WERE 7 -8 MM IN DIAMETER; BILATERALLY. IMAGES POST-IMPLANT WERE NOT PROVIDED. THE CAUSE OF THE REPORTED STENT GRAFT OCCLUSION ON THE LEFT SIDE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE SMALL AND CALCIFIED AORTIC BIFURCATION AND SEVERELY ANGULATED AND CALCIFIED LEFT COMMON ILIAC ARTERY MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381269 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04186606

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention