BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT LILAC STENT GRAFT

    MDR report key: 2050892 · Received April 1, 2011

    Report

    Report Number
    2953200-2011-00743
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: TREATMENT OF A DISSECTED PENETRATING ULCER, OCCLUSION, SMALL AORTIC BIFURCATION, SHORT AORTA. CONCLUSION: SMALL AORTIC BIFURCATION, SHORT AORTA.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT WAS IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF A DISSECTED PENETRATING ULCER OF THE ABDOMINAL AORTA, APPROX ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS AN AORTIC NECK DIAMETER OF 14 MM AND AN AORTIC BIFURCATION THAT MEASURED 12 MM IN DIAMETER. THE AORTA WAS 9 CM LONG FROM THE LOWEST RENAL ARTERY TO THE TERMINAL AORTA . IT WAS REPORTED THAT AFTER THE BIFURCATED STENT GRAFT AND CONTRALATERAL LIMB WERE IMPLANTED THERE WAS NO PULSE ON THE RIGHT IPSILATERAL SIDE (SEE FILE # 2953200-2011-00742). IMAGES SHOWED THAT THERE WAS NO OUT FLOW ON THE RIGHT SIDE BECAUSE OF THE SMALL TERMINAL AORTA. THE PHYSICIAN IMPLANTED ANOTHER MANUFACTURER'S BALLOON EXPANDABLE STENT TO OPEN THE LIMB; HOWEVER, THE LEFT SIDE CLOSED AT THE LEVEL OF THE TERMINAL AORTA . THE PHYSICIAN THEN IMPLANTED ANOTHER MANUFACTURER'S EXPANDABLE STENT ON THE LEFT SIDE TO KEEP THE LIMB OPEN. THERE WAS GOOD BILATERAL FLOW AT THE END OF THE PROCEDURE. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT LILAC STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00792160

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention