BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 4872358 · Received June 26, 2015

    Report

    Report Number
    2953200-2015-00966
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    May 7, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON A FOLLOW UP CTA, IT SHOWED THE ABDOMINAL AORTIC ANEURYSM HAD INCREASED IN SIZE AND THERE WAS ALSO AN APPEARANCE OF ANEURX STENT GRAFT LIMB SEPARATION ON THE PATIENTS LEFT SIDE. AN ENDURANT II LIMB STENT GRAFT WAS SUCCESSFULLY IMPLANTED TO RE-LINE THE PATIENT'S EXISTING GRAFT ON THE LEFT SIDE AND THE EVENT RESOLVED. THE PHYSICIAN COULD NOT DETERMINE THE CAUSE OF SEPARATION BETWEEN THE DEVICE COMPONENTS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. FILM REVIEW ANALYSIS: A REVIEW OF SEVERAL STILL POST-IMPLANT CTA¿S OF THE ILIAC LIMBS CONFIRMED THAT THERE WAS A SEPARATION BETWEEN THE ANEURX STENT GRAFT LIMBS ON THE LEFT SIDE. THE AMOUNT OF SEPARATION WAS APPROXIMATELY 1CM, AND THERE WAS LITTLE RADIAL MISALIGNMENT. THE LIMBS WERE ESSENTIALLY STRAIGHT AT THIS DETACHED LOCATION WITHIN THE DISTAL ANEURYSM SAC. THE IMAGES RETURNED COULD NOT CONFIRM A TYPE III JUNCTIONAL ENDOLEAK, OR ANY ENDOLEAK, BUT ANY POSSIBLE ENDOLEAK MAY HAVE BEEN CONTAINED BY THROMBUS. THERE WERE ALSO POSSIBLE FRACTURED STENT RINGS NOTED ON THE PROXIMAL END OF THE DISTAL SEPARATED DEVICE. BOTH LIMBS WERE PATENT AND NO OTHER DEVICE ISSUES WERE OBSERVED. THE CAUSE OF THE LIMB DETACHMENT COULD NOT BE DETERMINED FROM THE LIMITED FILMS PROVIDED. EARLIER POST-IMPLANT IMAGES WERE NOT AVAILABLE FOR REVIEW AND THE AMOUNT OF LIMB OVERLAP AT IMPLANT IS UNKNOWN. IT IS POSSIBLE THAT ANEURYSM MORPHOLOGY CHANGES MAY HAVE CONTRIBUTED TO THE SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415444 ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR YRBR2615165

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention