BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2130584 · Received June 14, 2011

    Report

    Report Number
    2953200-2011-01135
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS: ARTERIAL/VESSEL OCCLUSION; SEVERELY TORTUOUS ILIACS BILATERALLY, WITH A SMALL DISTAL AORTA OF APPROX 22-24MM WITH CALCIFICATION. EVAL, CONCLUSION: SEVERELY TORTUOUS ILIACS BILATERALLY, WITH A SMALL DISTAL AORTA OF APPROX 22-24MM WITH CALCIFICATION.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.4 CM ABDOMINAL AORTIC ANEURYSM APPROX TWO MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS AN AORTIC NECK THAT WAS 19 MM TO 20 MM IN DIAMETER AND 26 MM LONG WITH CIRCUMFERENTIAL THROMBUS. IMA AND 4 LUMBAR ARTERIES ARE PATENT. THERE WAS 90 DEGREE ANGULATION AND CIRCUMFERENTIAL THROMBUS OF THE PROXIMAL RIGHT ILIAC ARTERY. THE ACCESS VESSELS WERE UNREMARKABLE AND 9-11 MM IN DIAMETER ON THE RIGHT AND 11 MM IN DIAMETER ON THE LEFT. IT WAS REPORTED THAT THE PT PRESENTED WITH AN ACUTE ISSUE OF THE LEFT LEG. THE LEFT CONTRALATERAL LIMB AND VESSEL WERE FOUND TO BE OCCLUDED BY THROMBUS. THE PHYSICIAN TRIED TO OPEN THE VESSEL WITH A PERIPHERAL INFUSION SYSTEM AND A FOGARTY BALLOON PROCEDURE AND PUT 2 KISSING STENTS AT THE AORTA BIFURCATION. THE FLOW IMPROVED BUT WAS NOT COMPLETELY RESOLVED OR ALL THE THROMBUS REMOVED, SO A FEMORAL TO FEMORAL BYPASS WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. INTERNAL REVIEW OF THE RETURNED FILMS AT PRE-IMPLANT SHOW SEVERELY TORTUOUS ILIACS BILATERALLY, WITH A SMALL DISTAL AORTA OF APPROX 22-24MM WITH CALCIFICATION. POST-IMPLANT FILMS SHOW AN OCCLUDED CONTRALATERAL (LEFT) LIMB BEGINNING PROXIMAL TO THE FLOW DIVIDER, AND THE LIMBS ARE SQUEEZED TOGETHER AT THE DISTAL AORTA (THE CONTRALATERAL LIMB IS PINCHED MORE THAN THE IPSILATERAL). THE DISTAL LEFT ILIAC TAKES AN ABRUPT TURN JUST PAST THE DISTAL ILIAC STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00840655

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention