BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2951146 · Received February 8, 2013

    Report

    Report Number
    2953200-2013-00236
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FILM. RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION, STENT GRAFT KINK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (NARROW DISTAL AORTA). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (NARROW DISTAL AORTA).

    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 APPROXIMATELY SIX MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT DURING THE INITIAL IMPLANT THE STENT GRAFTS WERE MODELED WITH A BALLOON. A CT POST IMPLANT REVEALED THAT THE DISTAL AORTA WAS 15 MM IN DIAMETER WITH THE STENT GRAFTS IMPLANTED AND THE ILIAC LIMBS WERE CROSSED. THREE WEEKS AGO THE PATIENT PRESENTED WITH LOWER LEG PAIN AND A CT REVEALED THAT THE CONTRALATERAL SIDE WAS OCCLUDED UP TO THE FLOW DIVIDER RESULTING IN LIMITED BLOOD FLOW. THE CONTRALATERAL ILIAC STENT GRAFT LIMB AND THE GATE OF THE BIFURCATED STENT GRAFT WERE KINKED. THE PHYSICIAN BELIEVES THAT THE COMBINATION OF THE SMALL DIAMETER DISTAL AORTA AND THE MODELING THE STENT GRAFT WITH A BALLOON ONE SIDE AT A TIME (NO KISSING BALLOON) MOST LIKELY CAUSED THE OCCLUSION. THE DECISION WAS MADE TO PERFORM A FEMORAL TO FEMORAL BYPASS WHICH SUCCESSFULLY RESTORED BLOOD FLOW TO THE LOWER EXTREMITIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF SEVERAL RETURNED STILL ANGIO IMAGES SHOWED THAT THE CONTRALATERAL LIMB WAS WITHIN THE LEFT ILIAC, CROSSING OVER THE IPSILA TERAL LIMB. THE CONTRALATERAL LIMB IS OCCLUDED FROM ABOVE THE FLOW DIVIDER THROUGH THE ENTIRE LENGTH OF THE CONTRALATERAL LIMB. THE LEFT LIMB APPEARS KINKED APPROXIMATELY 2 RINGS BELOW THE GATE, POSSIBLY IN THE AREA OF THE DISTAL AORTA WHERE IT CROSSES THE IPSIL ATERAL LIMB. THE CAUSE APPEARS ANATOMY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53522 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01126827

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention