BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ILIAC STENT GRAFT

    MDR report key: 2160632 · Received July 6, 2011

    Report

    Report Number
    2953200-2011-01244
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ARTERIAL OCCLUSION). (A TORTUOUS AORTA). CONCLUSION: (A TORTUOUS AORTA).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM TWO MONTHS AGO. THE ILIAC ARTERIES HAD MODERATE TORTUOSITY AND A SMALL AMOUNT OF CALCIFICATION. IT WAS REPORTED THAT AN AUI DEVICE WAS PLANNED AS THE PATIENT ALREADY HAD A FEMORAL TO FEMORAL CROSSOVER IN SITU. THE LEFT INTERNAL ILIAC WAS EMBOLIZED SUCCESSFULLY PRIOR TO ENDURANT AUI PLACEMENT (REF MFR 2953200-2011-01242). TWO ILIAC LIMBS WERE ALSO IMPLANTED (REF MFR 2953200-2011-01243). THERE WERE NO COMPLICATIONS DURING PROCEDURE. A SMALL BLUSH WAS NOTED AT FINAL ANGIOGRAPHY RUN. THE SURGEON DECIDED TO REVIEW THE BLUSH AT THE POST-OPERATIVE VISIT. THE POST-OPERATIVE CT CONFIRMED THAT THE BLUSH WAS RESOLVED. ONE MONTH AGO, THE PATIENT PRESENTED WITH AN OCCLUDED STENT GRAFT. THE PATIENT WAS ON WARFARIN FOR ATRIAL FIBRILLATION, THEREFORE, NO CAUSE FOR THE OCCLUSION COULD BE IDENTIFIED; HOWEVER, A PROXIMAL CLOT FROM A TORTUOUS AORTA WAS SUSPECTED. THE PATIENT HAS HAD AN AXILLO-FEMORAL BYPASS AND WAS DISCHARGED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. AN INTERNAL REVIEW OF RETURNED FILMS AT IMPLANT SHOW A LIKELY TYPE IV ENDOLEAK SEEN ON BOTH SIDES OF THE STENT GRAFT NEAR THE MID-LENGTH OF THE AUI MAIN BODY. THE ILIAC APPEARED NON-ANGULATED AND PATENT. FILMS POST-IMPLANT SHOW AN OCCLUDED STENT GRAFT BEGINNING AT THE PROXIMAL GRAFT MARGIN AND CONTINUING DISTALLY WITHIN ALL THE DEVICES. THE DISTAL ILIAC MEASURED AN APPROXIMATELY 11-12 MM DIAMETER AND THERE DID NOT APPEAR TO BE ANY KINKING OR CRUSHING ALONG THE LENGTH OF THE STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ILIAC STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00854645

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention