BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 2190793 · Received July 8, 2011

    Report

    Report Number
    2953200-2011-01262
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK, MIGRATION); (DISEASE PROGRESSION; NECK DILATATION). CONCLUSION: (DISEASE PROGRESSION; NECK DILATATION).

    Description of Event or Problem · 1

    AN ANEURX (REF MFR 2953200-2011-01262) ABDOMINAL STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 43 MONTHS AGO. VESSEL MORPHOLOGY FROM THE INDEX PROCEDURE IS UNK. CURRENT VESSEL MORPHOLOGY WAS REPORTED AS WAS SOME ANGULATION IN THE NECK, WHICH HAS DILATED TO A 34 MM DIAMETER AT THE RENALS, WITH A 2 CM LENGTH; AND NO CALCIFICATION IN THE NECK. IT WAS REPORTED THAT ONE MONTH AGO, THE ORIGINAL STENT GRAFT HAD MIGRATED 4 CM AND THERE WAS A TYPE 1 ENDOLEAK, PROBABLY DUE TO DISEASE PROGRESSION AND NECK DILATATION. THE PHYSICIAN PLACED A 36X16X124 TALENT CONVERTER (REF MFR 2953200-2011-01263) INTO THE RIGHT ANEURX LIMB, AND EXTENDED WITH A 16X65 ANEURX LIMB. AN 18 MM TALENT OCCLUDER WAS PLACED ON THE LEFT. TWELVE DAYS LATER, THERE APPEARED TO BE A QUESTIONABLE LEAK AT THE PROXIMAL ASPECT OF THE CONVERTER ON A FOLLOW-UP CT. A PALMAZ STENT WAS PLACED DUE TO A PLEAT IN THE GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00032759

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention