BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3140253 · Received May 31, 2013

    Report

    Report Number
    2953200-2013-01035
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 5, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, METHOD: (FILM); RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (NARROW AORTIC BIFURCATION, SMALL, SEVERELY CALCIFIED AND TORTUOUS ILIAC ARTERIES). CONCLUSION: INHERENT RISK OF A PROCEDURE (OCCLUSION); DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (NARROW AORTIC BIFURCATION, SMALL, SEVERELY CALCIFIED AND TORTUOUS ILIAC ARTERIES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 6.7 X 6.4 CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 15 MM IN LENGTH, 21 MM IN DIAMETER PROXIMALLY, THE 22 MM AND 24 MM DISTALLY. THE AORTIC BIFURCATION IS 26 X 26 MM. THE LEFT ILIAC ARTERY WAS 11, 12, 10 MM FROM PROXIMAL TO DISTAL AND THE RIGHT WAS 12, 16 AND 14 MM FROM PROXIMAL TO DISTAL. THE ILIAC ARTERIES WERE DESCRIBED AS SMALL, SEVERELY CALCIFIED AND TORTUOUS. IT WAS REPORTED THAT APPROXIMATELY FOUR WEEKS POST IMPLANT, THE PATIENT PRESENTED TO THE HOSPITAL WITH NO PULSE ON THE LEFT SIDE. A CT WAS DONE AND SHOWED THAT THE CONTRALATERAL LIMB WAS PARTIALLY OCCLUDED AND INVOLVED THE FLOW DIVIDER OF THE BIFURCATED STENT GRAFT. A FORGARTY CATHETER WAS USED TO REMOVE THROMBUS FROM WITHIN THE STENT GRAFTS, THEN TWO ENDURANT STENT GRAFTS A 13 X 13 AND A 16 X 16 WERE USED TO RELINE THE CONTRALATERAL LIMB FROM THE FLOW DIVIDER DOWN TO THE HYPOGASTRIC ARTERY IN ORDER TO CRUSH ANY RESIDUAL THROMBUS BETWEEN THE PREVIOUSLY IMPLANTED STENT GRAFT AND THE NEWLY IMPLANTED STENT GRAFTS. A 9X38 I-CAST STENT WAS IMPLANTED IN THE AREA OF TORTUOSITY AND THIS SUCCESSFULLY RESOLVED THE OCCLUSION. THE PHYSICIAN STATED THE EVENT IS ANATOMY RELATED AND NOT RELATED TO THE STENT GRAFTS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED FILMS PRE-IMPLANT CONFIRMED THAT THE ILIAC ARTERIES WERE SEVERELY CALCIFIED AND TORTUOUS. THE MAXIMUM ANEURYSM DIAMETER WAS 6.5CM, AND IT CONTAINED THROMBUS, AND THE AORTIC NECK WAS SEVERELY ANGULATED. SEVERAL POST-IMPLANT STILL ANGIO IMAGES AND A VIDEO WERE ALSO REVIEWED. THE DISTAL LEFT ILIAC LIMB (3 STENTS FROM THE DISTAL END) WAS SEEN KINKED TO 90DEG NEAR THE ORIGIN OF THE LEFT COMMON ILIAC ARTERY. AS NO CONTRAST WAS USED; THE AMOUNT OF OCCLUSION COULD NOT BE ASSESSED. AFTER RE-INTERVENTION, THE LEFT ILIAC LIMB SIGNIFICANTLY STRAIGHTENED, AND NO OCCLUSION WAS SEEN ON THE FINAL ANGIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241289 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04002133

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention