BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADEVANTAGE BIFURCATED STENT GRAFT

    MDR report key: 1222046 · Received November 6, 2008

    Report

    Report Number
    2953200-2008-01010
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    December 29, 2014
    Report Date
    December 29, 2014
    Manufacturer
    MEDTRONIC CARDIO VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: MIGRATION. TYPE II ENDOLEAK. EVALUATION CODE, CONCLUSION: TYPE II ENDOLEAK. PATIENT WILL BE MONITORED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT AND THE TIME OF THE EVENT ARE UNKNOWN. IT WAS REPORTED APPROXIMATELY 10 MONTH POST STENT GRAFT IMPLANTATION THE CT REVEALED THAT 1-3 MM DISTAL STENT GRAFT MIGRATION WITH NO EVIDENCE OF A TYPE I ENDOLEAK. THE PATIENT ALSO HAS A TYPE II ENDOLEAK. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE FILMS FOR THIS CASE HAVE BEEN REVIEWED BY A CONSULTANT PHYSICIAN. AT THE 6 MONTH FOLLOW-UP, THE CT DEMONSTRATED THAT THE STENT GRAFT BEGINS 9 MM BELOW THE LOWEST RENAL ARTERY AND AT THE TOP PART THERE IS SOME LOSS OF APPOSITION OF THE STENT GRAFT TO THE AORTIC WALL BUT DISTALLY THERE IS SEAL. THERE IS NO EVIDENCE OF AN ENDOLEAK ON THIS EXAM. THERE IS GOOD SEAL OF THE DISTAL LIMBS OF THE GRAFTS. HOWEVER, ON THE RIGHT, THERE IS SOME LOSS OF APPOSITION DISTALLY OF THE RIGHT LIMB OF THE GRAFT NEAR THE INTERNAL ILIAC ARTERY. THE AAA MEASURES AT 47 MM IN ITS GREATEST DIAMETER. THREE MONTHS LATER, THE CT FINDINGS ARE VERY SIMILAR TO THE ABOVE FINDINGS. HOWEVER, THE GRAFT MAY HAVE SLIGHTLY MIGRATED DISTALLY AS THERE NOW APPEARS TO BE ABOUT 10-12 MM OF DISTANCE BETWEEN THE LOWEST RENAL ARTERY AND THE FULL APPOSITION OF THE STENT GRAFT. DISTALLY, THERE IS A VERY SMALL TYPE II ENDOLEAK. THIS ENDOLEAK APPEARS TO BE COMING FROM A LUMBAR ARTERY THAT IS FILLING THE ANEURYSM SAC. THERE IS GOOD SEAL DISTALLY. HOWEVER, ON THE RIGHT, THERE IS SOME LOSS OF APPOSITION DISTALLY OF THE RIGHT LIMB OF THE GRAFT NEAR THE INTERNAL ILIAC ARTERY. THE AAA IS MEASURED 47 MM IN ITS GREATEST DIAMETER. THE PATIENT WAS REPORTED TO BE FINE AND NO ADDITIONAL CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SUCCESSFULLY TREATED WITH AN ENDURANT II 36X36X49 CUFF. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADEVANTAGE BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIO VASCULAR NA V00065535

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention