BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2161875 · Received July 8, 2011

    Report

    Report Number
    2953200-2011-01255
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK, DISSECTION), (SEVERELY ANGULATED NECK), (SEVERELY ANGULATED NECK), (GUIDEWIRE). EVALUATION, CONCLUSION: (SEVERELY ANGULATED NECK), (SEVERELY ANGULATED NECK), (GUIDEWIRE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN APPROXIMATELY 5.4 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THERE WAS DIFFICULTY GETTING THE GUIDE WIRES INTO THE AORTA. THIS PROCESS TOOK 2 HOURS. THE PHYSICIAN DISSECTED THE RIGHT COMMON ILIAC WHEN THE GUIDE WIRE WENT SUBINTIMAL. THE GUIDE WIRE WAS FINALLY ADVANCED INTO THE AORTA. IMAGES TAKEN OF THE PROXIMAL NECK WERE NOT CLEAR. THE PT HAD A RIGHT ACCESSORY RENAL APPROXIMATELY 1 CM BELOW THE DOMINANT RIGHT RENAL ARTERY. THE BIFURCATED STENT GRAFT WAS DEPLOYED WITH THE STENT GRAFT PURPOSELY LANDING ABOVE THE DISTAL AORTA, SO THAT THE IPSILATERAL LIMB WOULD BE POSITIONED ABOVE THE RIGHT COMMON ILIAC. A 16 X 13 TAPERED LIMB WAS ADDED TO THE RIGHT IPSILATERAL SIDE. A 16X16X82 LIMB WAS ADDED TO THE LEFT SIDE. THE IVUS CATHETER BROKE DURING THE PROCEDURE. THE CASE TOOK SEVEN HOURS. AT THE END OF THE CASE, ANGIOGRAM SHOWED A SMALL PROXIMAL TYPE I ENDOLEAK ON THE LEFT ANTERIOR SIDE OF THE BIFURCATED STENT GRAFT. THERE WAS NO JETTING. THE ENDOLEAK DID NOT RESOLVE WITH BALLOONING. THE TYPE I ENDOLEAK MAY BE ANATOMY RELATED DUE TO THE SEVERELY ANGULATED NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00878900

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention