BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2063872 · Received April 15, 2011

    Report

    Report Number
    2953200-2011-00814
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    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

    (B)(4). EVALUATION, RESULTS: OCCLUSION. MILDLY TORTUOUS AND MILDLY CALCIFIED, AORTIC NECK ANGULATION, CALCIFICATION. AORTIC CUFF WAS IMPLANTED LOWER THAN INTENDED AND OCCLUDED THE CONTRALATERAL LIMB. CONCLUSIONS: MILDLY TORTUOUS AND MILDLY CALCIFIED, AORTIC NECK ANGULATION, CALCIFICATION. AORTIC CUFF WAS IMPLANTED LOWER THAN INTENDED AND OCCLUDED THE CONTRALATERAL LIMB.

    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. VESSEL MORPHOLOGY WAS REPORTED AS MILDLY TORTUOUS AND MILDLY CALCIFIED, WITH AN AORTIC NECK, CALCIFICATION AND ANGULATION SLIGHTLY LESS THAN 45 DEGREES. THE AORTIC NECK DIAMETER WAS 21-23 MM WITH A LENGTH OF 20 MM. A PROXIMAL TYPE I ENDOLEAK WAS NOTED AND A 26 CM CUFF WAS PLACED WHICH CORRECTED THE ENDOLEAK (REF MFR # 2953200-2011-00125). IT WAS REPORTED THE PATIENT HAD A ROUTINE CT THREE MONTHS POST-IMPLANT, WHICH DEMONSTRATED A PROXIMAL TYPE I ENDOLEAK AND THERE WAS OCCLUSION OF THE CONTRALATERAL LIMB. (REF MFR # 2953200-2011-00813). IT APPEARS THAT THE AORTIC CUFF THAT WAS IMPLANTED FOR THE REPORTED INITIAL TYPE I ENDOLEAK WAS IMPLANTED LOWER THAN INTENDED OCCLUDING OFF THE CONTRALATERAL LIMB. THE PATIENT WAS BACK AT A LATER DATE AND AN ENDURANT AORTIC CUFF WAS IMPLANTED AND SUCCESSFULLY RESOLVED THE PROXIMAL ENDOLEAK. CURRENTLY THE PATIENT HAS COLLATERAL CIRCULATION AND NO SYMPTOMS OR ISSUES DUE TO THE OCCLUDED STENT GRAFT. FILMS WERE RECEIVED AND THEIR EVALUATION WAS COMPLETED. REVIEW OF THE THREE MONTH POST-IMPLANT FILMS SHOW CALCIFICATION WITHIN THE AORTIC NECK WHICH MAY HAVE CONTRIBUTED TO THE PROXIMAL TYPE I ENDOLEAK. THE FILMS ALSO CONFIRMED THAT THE CUFF HAD BEEN PLACED LOW IN THE BIFURCATE AORTIC BODY AND WAS COVERING THE CONTRALATERAL LIMB. THE CONTRA LIMB WAS OCCLUDED DISTALLY FROM THE FLOW DIVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC IRELAND NA V00553178

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention