BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3944223 · Received July 18, 2014

    Report

    Report Number
    2953200-2014-01411
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: AORTIC NECK NARROW TO <(><<)> 18 MM IN DIAMETER.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4 48 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 40 MM IN LENGTH. AT ABOUT 2CM BELOW THE RENAL ARTERY THE AORTIC NECK DIAMETER NARROWED TO APPROXIMATELY 14MM AND IT WAS CALCIFIED. IT WAS REPORTED THAT AFTER THE STENT GRAFT WAS IMPLANTED AND BALLOONED A SMALL TYPE I ENDOLEAK REMAINED. THE PHYSICIAN BALLOONED MORE AGGRESSIVELY A SECOND TIME. WHEN THE NARROW AREA WAS BALLOONED WITH ANOTHER MANUFACTURER'S BALLOON, THE NARROWED AREA APPEARED TO ABRUPTLY GIVE WAY AND EXPAND. THE BALLOON WAS EXPOSED 1 CM TO THE VESSEL WALL ABOVE THE STENT GRAFT BUT BELOW THE ANCHORS. IT IS UNKNOWN HOW MUCH FLUID WAS USED TO INFLATE THE BALLOON. UPON SUBSEQUENT ANGIOGRAPHY IT WAS NOTICED THE ENDOLEAK WAS SEALED; HOWEVER, THERE APPEARED TO BE A RUPTURE AND POSSIBLY A HOLE IN THE STENT GRAFT NEAR THE AREA OF THE CALCIUM IN THE AORTIC NECK. THE PHYSICIAN OBSERVED EXTRAVASATION OF CONTRAST OUTSIDE THE STENT GRAFT IN AN AREA WHERE IT WAS NOT PREVIOUSLY OBSERVED AND THE CONTRAST WAS DENSE AND FOCAL. AN ENDURANT AORTIC CUFF OF THE SAME DIAMETER AS THE BIFURCATED STENT GRAFT WAS IMPLANTED TO GAIN 1CM OF SEAL BETWEEN THE TOP OF THE BIFURCATED STENT GRAFT AND THE RENAL ARTERY. THE FINAL ANGIOGRAM RUN REVEALED THAT THE ENDOLEAK/RUPTURE (OR HOLE IN THE GRAFT) WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED PRE-IMPLANT CTAS REVEALED THAT THE PROXIMAL AORTIC NECK WAS SEVERELY CALCIFIED. THE AORTIC NECK DIAMETER JUST BELOW THE RENAL ARTERIES MEASURED 18MM. JUST ABOVE THE START OF THE ANEURYSM THE PROXIMAL AORTIC NECK MEASURED APPROXIMATELY 12 X 13MM AND WAS SEVERELY CALCIFIED. THE MAXIMUM ANEURYSM DIAMETER WAS 47MM, AND CONTAINED THROMBUS. THE DISTAL AORTIC DIAMETER WAS APPROXIMATELY 15MM AND WAS ALSO CALCIFIED. BOTH ILIAC ARTERIES WERE MODERATELY TORTUOUS AND CALCIFIED. IMAGES INTRA-OPERATIVELY OR POST-IMPLANT WERE NOT PROVIDED. THE CAUSE OF THE PERFORATION COULD NOT BE CONFIRMED; HOWEVER, IT IS LIKELY THAT BALLOONING WITHIN THE SMALL AND CALCIFIED AORTA MAY HAVE CAUSED THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422913 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04060000

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention