BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2010785 · Received March 2, 2011

    Report

    Report Number
    2953200-2011-00577
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: MIGRATION, ENDOLEAK, DISEASE PROGRESSION AND ENLARGEMENT OF THE AORTA. EVALUATION, CONCLUSION: DISEASE PROGRESSION AND ENLARGEMENT OF THE AORTA.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC RUPTURE APPROXIMATELY 3 YEARS AGO. THE VESSEL MORPHOLOGY SHOWED THAT THE NECK WAS APPROXIMATELY 2 CM LONG, CONICAL AND SOMEWHAT ANGULATED. THE WHOLE AORTA WAS ANGULATED AS WELL. OTHER VESSEL MORPHOLOGY IS UNK. THE ANEURYSM WAS FOUND TO HAVE GROWN BETWEEN THE STUDIES 2 YEARS AGO AND 2 MONTHS AGO FROM 4.1 X 5.7 CM TO 5.5 X 6.2 CM. THE ANEURX DEVICE HAS MIGRATED TO 3.2 CM DISTAL TO THE LOWER RENAL ARTERY WITH A TYPE I ENDOLEAK. AN ENDURANT BIFURCATED STENT GRAFT AND CONTRALATERAL LIMB WERE IMPLANTED APPROXIMATELY 3 WEEKS AGO WHICH RESOLVED THE ENDOLEAK / MIGRATION. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00100826

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention