BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (HDM FLEXIBLE) WITH XPEDIENT

    MDR report key: 1080737 · Received July 23, 2008

    Report

    Report Number
    2953200-2008-00573
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 25, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: (SEVERE DEGENERATIVE CHANGES AND SCOLIOSIS WITHIN THE LUMBAR SPINE), (MIGRATION). CONCLSUION (SEVERE DEGENERATIVE CHANGES AND SCOLIOSIS WITHIN THE LUMBAR SPINE). OTHER - (REQUIRES SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 37 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. A CT OF THE ABDOMEN PERFORMED FOR THE 1 YR FOLLOW-UP DOCUMENTED UNCHANGED APPEARANCE AND POSITION OF THE ABDOMINAL AORTIC ANEURYSM STENT GRAFT AND NO EVIDENCE OF MIGRATION. IT ALSO DOCUMENTED SEVERE DEGENERATIVE CHANGES AND SCOLIOSIS WITHIN THE LUMBAR SPINE WITH MARKED FACET ARTHROPATHY AT MULTIPLE LEVELS. AN ANGIO ABDOMEN AND PELVIS APPROX ONE MONTH AGO DOCUMENTED THE ANEURYSM IS IDENTIFIED MEASURING 5.8 X 4.9 CM IN MAXIMUM DIAMETER. A STENT GRAFT IS IN PLACE AND BEGINS WELL BELOW THE ORIGINS OF THE RENAL ARTERIES AND EXTENDS INTO THE ILIAC VESSELS BILATERALLY "POTENTIAL MIGRATION". THERE IS NO EVIDENCE OF AN ENDOLEAK OBSERVED. NO ADD'L INFO WAS PROVIDED AND NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (HDM FLEXIBLE) WITH XPEDIENT MIH MEDTRONIC CARDIOVASCULAR NA 358148

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention