BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1013778 · Received March 14, 2008

    Report

    Report Number
    2953200-2008-00133
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 18, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: ENDOLEAK. TORTUOUS AORTIC NECK. EVALUATION: CONCLUSION: TORTUOUS AORTIC NECK.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM WAS 6 X 5 CM AND TORTUOUS AORTIC NECK. IT WAS REPORTED THERE WERE NO COMPLICATIONS REPORTED SINCE IMPLANT; HOWEVER, A RECENT RADIOLOGY REPORT DOCUMENTED THAT COMPARISON IS MADE TO A PRIOR FROM 8 MONTHS AGO WHERE THERE WAS MARKED AORTIC TORTUOUSITY AGAIN NOTED. THERE HAS BEEN A CHANGE IN THE CONFIGURATION OF THE AORTO-ILIAC STENT GRAFT. THE ANEURYSM CURRENTLY MEASURED 5.8 X 6.8 CM AND THIS RAISED THE POSSIBILITY OF INTERVAL LEAKAGE BUT NO OBVIOUS ENDOGRAFT LEAK WAS IDENTIFIED. THE ANEURYSM TAPERED AT THE DIVERSION OF THE ILIAC PORTION OF THE STENT. DELAYED IMAGES DEMONSTRATED NO OBVIOUS CONTRAST EXTRAVASATION OR INCREASED ATTENUATION; HOWEVER, SOME DEGREE OF LEAKAGE IS SUSPECTED GIVEN THE INTERVAL INCREASE IN SIZE. THE REMAINDER OF THE EXAM IS UNCHANGED. IT WAS ALSO REPORTED THAT ANOTHER MANUFACTURER'S AORTIC CUFF WAS IMPLANTED ON AN UNKNOWN DATE, BUT THAT DID NOT RESOLVE THE ENDOLEAK. CLOSE INTERVAL FOLLOW-UP WAS RECOMMENDED. THE DECISION WAS MADE TO PERFORM AN OPEN SURGICAL REPAIR TO EXPLANT THE STENT GRAFTS, BUT WHEN THE PATIENT WAS SENT TO SURGERY THE DECISION WAS TO EXPLANT THE OTHER MANUFACTURER'S CUFF ONLY AND ANEURX STENT GRAFTS WERE LEFT IN PLACE. A DACRON GRAFT WAS SEWN TO THE AORTA JUST BELOW THE RENAL ARTERIES AND TO THE TOP OF THE ANEURX BIFUR AND SUCCESSFULLY ELIMINATED THE PROXIMAL TYPE 1 ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA C02511

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention