BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2770884 · Received October 3, 2012

    Report

    Report Number
    2953200-2012-01898
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    June 20, 2011
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM THREE YEARS AGO. ANEURYSM MORPHOLOGY FROM THE TIME OF IMPLANT WAS REPORTED AS THE AORTIC NECK WAS 1 CM LONG AND THE AORTIC NECK DIAMETER AND OTHER VESSEL MORPHOLOGY ARE UNKNOWN. IT WAS REPORTED THAT THE STENT GRAFT WAS ORIGINALLY IMPLANTED RIGHT AT THE LEVEL OF THE RENAL ARTERIES. ONE MONTH AGO, THE PATIENT CAME IN FOR A ROUTINE FOLLOW-UP AND THE STENT GRAFT WAS FOUND TO HAVE MIGRATED 10 MM AND WAS BARELY IN THE NECK, WITH NO ENDOLEAK PRESENT. THE AORTIC NECK CURRENTLY MEASURES 32 MM IN DIAMETER AND THE ANEURYSM IS 10 CM IN DIAMETER. THE PATIENT IS ASYMPTOMATIC. THE DECISION WAS MADE TO PLACE A 36 MM ENDURANT AORTIC CUFF TO RESOLVE THE BIFURCATED STENT GRAFT MIGRATION. IT WAS REPORTED THAT ONE MONTH AGO THE PATIENT PRESENTED SYMPTOMATICALLY. IT WAS REPORTED THAT AN INTERVENTION TOOK PLACE TO RESOLVE A TYPE III ENDOLEAK (SEPARATION) WHICH OCCURRED BETWEEN THE BIFURCATED STENT GRAFT AND THE 36 MM ENDURANT CUFF. THE PHYSICIAN ELECTED TO REPAIR THE ENDOLEAK WITH ANOTHER MANUFACTURER'S STENT GRAFT. THIS REPAIR WAS REPORTED TO BE UNSUCCESSFUL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. FILM REVIEW OF RETURNED FILMS TWO YEARS POST-IMPLANT SHOWED THAT THE BIFURCATE STENT GRAFT IS 15-20MM BELOW THE RENAL ARTERIES; THE IPSILATERAL LIMB IS ON THE RIGHT SIDE AND TAKES AN ABRUPT ANGLE WITHIN THE ANEURYSM SAC. AN ENDURANT AORTIC CUFF WAS PLACED AT THE RENAL ARTERIES OVERLAPPING THE BIFURCATE BY APPROXIMATELY 2CM. NO OBVIOUS ENDOLEAK IS SEEN. POST-IMPLANT CTA'S THREE YEARS POST INDEX PROCEDURE SHOW THAT THE BIFURCATE STENT GRAFT IS 2.5-3CM BELOW THE RENAL ARTERIES, AND THE CUFF REMAINS JUST BELOW THE RENAL ARTERIES. THERE IS APPROXIMATELY 15-20MM OF OVERLAP BETWEEN THE CUFF AND BIFURCATE. THERE IS AN ENDOLEAK SEEN APPROXIMATELY 5CM BELOW THE RENAL ARTERIES; POSSIBLY A TYPE III SEPARATION OR TYPE III FABRIC ENDOLEAK. THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention