BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX BIFURCATED SG W/XCELERANT DELIVERY SYSTEM

    MDR report key: 5206184 · Received November 5, 2015

    Report

    Report Number
    2953200-2015-01904
    Event Type
    Death
    Date Received
    November 5, 2015
    Date of Event
    October 11, 2015
    Report Date
    October 11, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF FIVE STILL ANGIO IMAGES DURING THE SECONDARY INTERVENTION CONFIRMED THAT THE ANEURX STENT GRAFT WAS ABOUT 30 MM BELOW THE LOWER LEFT RENAL ARTERY AND INSIDE THE ANEURYSM SAC. INJECTION OF THE CONTRAST SHOWED THAT THE CONTRAST WAS FILLING THE ANEURYSM SAC FROM THE PROXIMAL TYPE I ENDOLEAK. THE CURRENT FLOW LUMEN DIAMETER JUST BELOW THE RENAL MEASURED 17 MM IN DIAMETER AND 6 MM IN LENGTH. THE FLOW LUMEN 1 CM DISTAL TO THE RENAL ARTERY MEASURED APPROXIMATELY 30 MM IN DIAMETER. NO OTHER STENT GRAFT ISSUES WERE OBSERVED. THE ENDURANT CUFF WAS SEEN INSERTED THROUGH THE IPSILATERAL LIMB OF THE ANEURX BIFURCATE (LEFT SIDE). THE ENDURANT CUFF WAS POSITIONED JUST BELOW THE LOWEST LEFT RENAL ARTERY INTO THE AORTIC BODY AND DOWN TO THE FLOW DIVIDER. PRE-IMPLANT FILMS AND SIZING INFORMATION ARE NOT AVAILABLE. EARLIER POST IMPLANT FILMS AND POST-INTERVENTION FILMS WERE NOT PROVIDED. CLEAR IMAGES POST CUFF IMPLANT WERE NOT AVAILABLE. THE EXACT CAUSE OF STENT GRAFT MIGRATION LEADING TO THE PROXIMAL TYPE I ENDOLEAK COULD NOT BE DETERMINED; IT APPEARS TO BE DUE TO DISEASE PROGRESSION, NECK DILATATION.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RUPTURED ANEURYSM. IMAGES SHOWED THE DEVICE WAS WELL BELOW THE RENAL ARTERIES AND THERE WAS A LARGE PROXIMAL TYPE 1 ENDOLEAK. THE PHYSICIAN IMPLANTED A 32X32X49 ENDURANT CUFF HOWEVER, THE PATIENT EXPIRED DUE TO COMPLICATIONS OF THE RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737014 ANEURX BIFURCATED SG W/XCELERANT DELIVERY SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA YRBRHXC2615165

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death| R