BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2023369 · Received March 16, 2011

    Report

    Report Number
    2953200-2011-00653
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (OCCLUSION); (STENOSIS DISTAL TO THE IPSILATERAL LIMB); (OTHER MFR'S STENTS). EVAL, CONCLUSION: (OTHER MFR'S STENTS).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM, APPROXIMATELY TWO MONTHS AGO. THE PT HAD A 42.4 MM DIAMETER AAA. THE BIFURCATED STENT GRAFT WAS IMPLANTED ON THE PT'S LEFT SIDE. ANEURYSM AND VESSEL MORPHOLOGY WERE AORTIC NECK 22 MM IN DIAMETER AND 26 MM LONG, WITH MILD ANGULATION, MILD THROMBUS, AND MILD CALCIFICATION. ILIACS HAD MILD CALCIFICATION OTHER THAN AN AREA OF STENOSIS DISTAL TO THE IPSILATERAL LIMB. IT WAS REPORTED THAT THE PHYSICIAN PLACED ANOTHER MFR'S 9MM STENT IN THE AREA OF STENOSIS AND FLARED IT INTO THE ENDURANT LIMB AND DISTALLY INTO THE EXTERNAL ILIAC ARTERY. APPROX THREE WEEKS LATER, THE IPSILATERAL LIMB WAS FOUND TO HAVE OCCLUDED ALL THE WAY UP TO THE FLOW DIVIDER POSSIBLE BECAUSE THE OTHER MFR'S STENT MAY HAVE KINKED. WITH DIFFICULTY, THE WIRE WAS INSERTED AND A BALLOON WAS USED TO REMOVE AS MUCH OF THE CLOT AS POSSIBLE. THE OTHER MFR'S STENT WAS BALLOONED TO STRAIGHTEN IT. THERE WAS A PIECE OF CLOT SITTING AT THE FLOW DIVIDER THAT COULD NOT BE REMOVED; THEREFORE, THE RIGHT SIDE WAS ACCESSED, BUT THE REMAINDER OF THE CLOT COULD NOT BE REMOVED. THE PHYSICIAN THEN PLACED TWO ENDURANT ILIAC EXTENSION LIMBS, ONE ON EITHER SIDE OF THE FLOW DIVIDER, USING THE KISSING TECHNIQUE, WHICH SECURED THE CLOT BETWEEN THEM. THE PT WAS PUT ON COUMADIN. THERE WAS GOOD BLOOD FLOW BILATERALLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00563753

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention