BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3002897 · Received March 13, 2013

    Report

    Report Number
    2953200-2013-00446
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK, DEPLOYMENT DIFFICULTY. CONICALLY SHAPED AORTIC NECK. CONCLUSION: CONICALLY SHAPED AORTIC NECK.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 52 MM DIAMETER ABDOMINAL AORTIC ANEURYSM AND A 45 MM DIAMETER RIGHT ILIAC ARTERY ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE AORTIC NECK WAS 29 MM IN DIAMETER BELOW THE RENAL ARTERIES AND 32 MM DISTALLY WITH A LENGTH OF 26 MM. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT WAS DEPLOYED JUST BELOW THE RENAL ARTERY AND IT TOOK SOME TIME TO RELEASE ONE OF THE SUPRARENAL STENT STRUTS DURING THE DEPLOYMENT DUE TO THE AORTIC NECK ANATOMY. THE STENT GRAFT SEEMED TO HAVE MOVED DISTALLY FROM THE INTENDED LOCATION WHICH CAUSED IT TO BE INACCURATELY DELIVERED AND RESULTED IN A PROXIMAL TYPE I ENDOLEAK. AN ENDURANT AORTIC CUFF WAS IMPLANTED AND TOUCH-UP WITH THE RELIANT BALLOON WAS DONE THREE TIMES; HOWEVER, THE ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN BELIEVES THAT THE TYPE IA ENDOLEAK WILL RESOLVE AND DECIDED TO MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104809 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01728411

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention