BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1772364 · Received July 23, 2010

    Report

    Report Number
    2953200-2010-01378
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 24, 2010
    Report Date
    June 24, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: (ENDOLEAK, RUPTURED VESSEL/ANEURYSM), (SEVERELY-DISEASED AND MODERATELY TORTUOUS VESSELS), OTHER (LOT NUMBER UNKNOWN).

    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 APPROXIMATELY TWO YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY, AND THE CT DEMONSTRATED THAT THERE WAS A DISTAL TYPE I ENDOLEAK AND A CONTAINED RUPTURE. AT THE TIME OF THE EVENT, THE VESSEL MORPHOLOGY WAS REPORTED AS SEVERELY-DISEASED, MODERATE TORTUOSITY, AND MILD CALCIFICATION. THE PHYSICIAN ELECTED TO INTERVENE BY PLACING A TALENT ILIAC LIMB, WHICH SUCCESSFULLY RESOLVED THE DISTAL ENDOLEAK. IN ADDITION, ALTHOUGH THERE WAS NO PROXIMAL TYPE I ENDOLEAK, THE PHYSICIAN ELECTED TO PLACE TWO ANEURX AORTIC CUFFS PROXIMALLY AS A PREVENTIVE MEASURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention