BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3945206 · Received July 18, 2014

    Report

    Report Number
    2953200-2014-01419
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 22, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE (PRE-OPERATIVE RUPTURE).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THERE WAS ALSO AN ILIAC ANEURYSM THAT WAS UNTREATED. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH BELLY PAIN. A CT SCAN SHOWED THAT THE LEFT ILIAC ARTERY HAD A TYPE IB ENDOLEAK CAUSED BY DISEASE PROGRESSION. THE ABDOMINAL AORTIC ANEURYSM WAS 10.5 CM IN DIAMETER AND RUPTURED DUE TO THE TYPE IB ENDOLEAK, BUT IT WAS CONTAINED AND NOT ACTIVELY BLEEDING. IT WAS SUCCESSFULLY REPAIRED BY EXTENDING THREE ENDURANT STENT GRAFTS INTO THE LEFT EXTERNAL ILIAC. THE BIFURCATE AND CUFF WERE CLOSE TO SEPARATION, WITH THE BIFUR WAS BELOW THE MINIMUM OVERLAP MARKER, BUT THERE WAS NO SEPARATION OR ENDOLEAK OBSERVED, AND A 32X70 ENDURANT II CUFF WAS USED TO PROPHYLACTICALLY COVER THE AREA. IT IS UNKNOWN IF THERE WAS GREATER OVERLAP AT THE INDEX PROCEDURE. THE ILIAC ANEURYSM IS CURRENTLY 36 MM IN DIAMETER. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT PASSED AWAY EIGHT DAYS AFTER THE SECONDARY PROCEDURE. THE PHYSICIAN NEEDED TO REINTUBATE THE PATIENT, AND THE PATIENT WAS NOT EATING. THE FAMILY WITHDREW CARE AND THE PATIENT EXPIRED. PER THE PHYSICIAN, THE DEATH WAS UNRELATED TO THE DEVICE OR PROCEDURE. THE FAMILY DECIDED THEY DID NOT WANT TO REINTUBATE, AND DID NOT WANT TO CONTINUE CARE. A REVIEW OF SEVERAL RETURNED STILL ANGIO IMAGES REVEALED THAT THE AORTIC CUFF WAS POSITIONED APPROXIMATELY 1CM BELOW THE RENAL ARTERIES. THE BIFURCATE IPSILATERAL LIMB AND EXTENSION WERE PLACED INTO THE RIGHT ILIAC. THE REPORTED DISTAL TYPE IB ENDOLEAK OF THE LEFT ILIAC COULD NOT BE SEEN ON THE FILMS. A SMALL DIAMETER STENT GRAFT LIMB WAS SEEN EXTENDING INTO THE LEFT ILIAC, WELL BEYOND THE 22MM LEFT ILIAC LIMB, AND MAY HAVE BEEN PLACED TO RESOLVE THE REPORTED ENDOLEAK. APPROXIMATELY 1CM OF OVERLAP WAS SEEN BETWEEN THE AORTIC CUFF AND BIFURCATE, AND NO TYPE III OR OTHER ENDOLEAK WAS OBSERVED. THE STENT GRAFTS WERE NOT ANGULATED. AN ENDURANT CUFF WAS THEN SEEN IMPLANTED JUST PROXIMAL TO THE AORTIC CUFF EXTENDING DISTALLY INTO THE BIFURCATE AORTIC BODY. EARLIER FOLLOW-UP IMAGES WERE NOT PROVIDED. THE CAUSE OF THE TYPE IB ENDOLEAK COULD NOT BE DETERMINED; MAY BE DUE TO DISEASE PROGRESSION. THE CAUSE OF THE REPORTED CUFF/BIFURCATE SEPARATION ALSO COULD NOT BE DETERMINED. THE AMOUNT OF OVERLAP AT IMPLANT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422771 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04255637

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death